Informa Life Sciences is part of the Knowledge and Networking Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 3099067.

Informa
Key Sessions

Geoffrey Pot

Next Generation Biomanufacturing data via data Intergration & Predictive analytics

Shire

Sofie Stille

Safeguarding the biomanufacturing supply chain: practical steps to manage raw material and process risks

GE Healthcare

Oct 09
Show Filter
07:50 - 09:00

Registration

More
Showing of Streams
10:40 - 11:20

Morning Coffee

More
Showing of Streams
12:50 - 13:15

Lunch

More
13:15 - 13:20
Live Labs: Meet at the KNect365 Registration Desk
Info

Live Labs: Meet at the KNect365 Registration Desk

Join the Live Labs tour to gain an insight into some of the most innovative equipment and services to hit today’s biopharmaceutical market.


More
13:20 - 13:30
Info

Live Lab Tour: GE Healthcare

Overcoming today’s bioprocessing challenges – this app can help Modern bioprocessing faces significant challenges including the need for CAPEX investments that ensure process efficiency and speed to market. Meeting these demands requires the right technology from a trusted partner. Join GE Healthcare Life Sciences during the Live Labs Tour and experience a single-use biomanufacturing application that can simplify your journey. Learn about current trends and quickly identify solutions to overcome your specific pain points.

More
13:30 - 13:40
Info

Live Labs Tour: Gyros Protein

Bioprocess development has rapidly evolved to incorporate Quality-by-Design (QbD) principles that depend on deep scientific understanding about each process. Scaled down models and high-capacity testing generates large numbers of samples for analysis, increasing the demand for efficient and timely analytical support to monitor quantity and quality in products and processes.

Gyrolab® xPand provides automation and throughput that enables the rapid and efficient generation of data for large numbers of bioprocess samples. This throughput together with software designed to support bioprocess workflows streamlines and accelerates the implementation of QbD strategies in bioprocess development

More
13:40 - 13:50
Info

Live Lab Tour: Hamilton

Online monitoring of bioprocesses is an important tool in R&D, process development and production and is fundamental for process control. Its foremost advantage is the monitoring of sudden changes of critical process parameters by virtually unlimited sample numbers. 

Hamilton is one of the worldwide leaders in the design and manufacture of process instrumentation. Innovative process sensors are offered for online monitoring of pH, dissolved oxygen and cell density.


During the Live Lab Tour you will learn about the intelligent Arc sensors, the advantages of online cell density monitoring and single use products for upstream processes

More
13:50 - 14:00
Info

Live Lab Tour: Meissner Filtration Products

Meissner’s BioLink™ Modular Overmolding Technology reduces risk in your process by expanding upon the best attributes of conventional overmolding, while incorporating the process flexibility and adaptability of traditional mechanical connections. BioLink™ helps increase fluid path robustness, eliminates manually produced mechanical connections, delivers secure and permanent connectivity to filters and SGTs (singleuse gauge tees), and reduces the total number of fluid contact materials. This presentation will cover the basic BioLink™ components, which include lengths of Meissner’s own proprietary BioFlex® TPE tubing with BioLink™ overmolded unitized end-fittings, and standardized polypropylene modules and filter adaptors that are injection molded out of the same resin as Meissner’s filter product portfolio.

More
14:00 - 14:10
Info

Live Lab Tour: Saint-Gobain - ZERO® Capsule Filters:

Increase yield during filtration processes by eliminating downstream filter holdup. Saint-Gobain’s ZERO® filter capsules are engineered to
reduce liquid hold-up, permitting the maximum amount of valuable process intermediaries and drug product to pass through to downstream processes. These sterilizing-grade Capsule Filters incorporate a patented aseptic recovery port which prevents the loss of liquid held up in the filter without dilution, contamination, or over-pressurization.

More
Showing of Streams
15:40 - 16:10

Afternoon Coffee

More
Showing of Streams
Showing of Streams
18:25 - 20:25

End of Day 1 and Evening Entertainment

More
07:50 - 09:00 70 mins
Registration
09:00 - 09:10 10 mins
Continuous Manufacturing
Chairperson's Opening Remarks
  • Tommy Fanning - Head of Biopharmaceuticals & Food, IDA
09:00 - 09:10 10 mins
Cell Culture & Upstream Process Development
Chairperson's Opening Remarks
  • Tommy Fanning - Head of Biopharmaceuticals & Food, IDA
09:00 - 09:10 10 mins
Downstream Processing
Chairperson's Opening Remarks
  • Tommy Fanning - Head of Biopharmaceuticals & Food, IDA
09:00 - 09:10 10 mins
Manufacturing Strategy & Technology
Chairperson's Opening Remarks
  • Tommy Fanning - Head of Biopharmaceuticals & Food, IDA
09:00 - 09:10 10 mins
Smart Factories
Chairperson's Opening Remarks
  • Tommy Fanning - Head of Biopharmaceuticals & Food, IDA
09:00 - 09:10 10 mins
Microbial Manufacturing
Chairperson's Opening Remarks
  • Tommy Fanning - Head of Biopharmaceuticals & Food, IDA
09:00 - 09:10 10 mins
Bioanalytical Congress
Chairperson's Opening Remarks
09:10 - 09:50 40 mins
Info
Continuous Manufacturing
Next Generation Biomanufacturing data via data Intergration & Predictive analytics
  • Geoffrey Pot - VP Technical Services, Shire

Availability of clinical trial material meeting all safety and quality relevant parameters is very often the bottleneck for effective and efficient product development at the same time high costs for routine GMP manufacturing are prohibiting global availability of novel, meaningful therapies. Recently introduced platform approaches, manufacturing technologies, single-use/disposable systems and Process Analytical technology (PAT) have helped to accelerate and de-risk product development and reduce cost of goods (COGS) for commercial products but patient requirements are still not met and affordability of meaningful therapies is still a hurdle for global launches. Digitalisation, automatization, new modalities and novel therapeutic approaches like gene editing and gene therapy are adding complexity but are also offering new opportunities for acceleration of product development and a significant reduction of COGs.

09:10 - 09:50 40 mins
Info
Cell Culture & Upstream Process Development
Next Generation Biomanufacturing data via data Intergration & Predictive analytics
  • Geoffrey Pot - VP Technical Services, Shire

Availability of clinical trial material meeting all safety and quality relevant parameters is very often the bottleneck for effective and efficient product development at the same time high costs for routine GMP manufacturing are prohibiting global availability of novel, meaningful therapies. Recently introduced platform approaches, manufacturing technologies, single-use/disposable systems and Process Analytical technology (PAT) have helped to accelerate and de-risk product development and reduce cost of goods (COGS) for commercial products but patient requirements are still not met and affordability of meaningful therapies is still a hurdle for global launches. Digitalisation, automatization, new modalities and novel therapeutic approaches like gene editing and gene therapy are adding complexity but are also offering new opportunities for acceleration of product development and a significant reduction of COGs.

09:10 - 09:50 40 mins
Info
Downstream Processing
Next Generation Biomanufacturing data via data Intergration & Predictive analytics
  • Geoffrey Pot - VP Technical Services, Shire

Availability of clinical trial material meeting all safety and quality relevant parameters is very often the bottleneck for effective and efficient product development at the same time high costs for routine GMP manufacturing are prohibiting global availability of novel, meaningful therapies. Recently introduced platform approaches, manufacturing technologies, single-use/disposable systems and Process Analytical technology (PAT) have helped to accelerate and de-risk product development and reduce cost of goods (COGS) for commercial products but patient requirements are still not met and affordability of meaningful therapies is still a hurdle for global launches. Digitalisation, automatization, new modalities and novel therapeutic approaches like gene editing and gene therapy are adding complexity but are also offering new opportunities for acceleration of product development and a significant reduction of COGs.

09:10 - 09:50 40 mins
Info
Manufacturing Strategy & Technology
Next Generation Biomanufacturing data via data Intergration & Predictive analytics
  • Geoffrey Pot - VP Technical Services, Shire

Availability of clinical trial material meeting all safety and quality relevant parameters is very often the bottleneck for effective and efficient product development at the same time high costs for routine GMP manufacturing are prohibiting global availability of novel, meaningful therapies. Recently introduced platform approaches, manufacturing technologies, single-use/disposable systems and Process Analytical technology (PAT) have helped to accelerate and de-risk product development and reduce cost of goods (COGS) for commercial products but patient requirements are still not met and affordability of meaningful therapies is still a hurdle for global launches. Digitalisation, automatization, new modalities and novel therapeutic approaches like gene editing and gene therapy are adding complexity but are also offering new opportunities for acceleration of product development and a significant reduction of COGs.

09:10 - 09:50 40 mins
Info
Smart Factories
Next Generation Biomanufacturing data via data Intergration & Predictive analytics
  • Geoffrey Pot - VP Technical Services, Shire

Availability of clinical trial material meeting all safety and quality relevant parameters is very often the bottleneck for effective and efficient product development at the same time high costs for routine GMP manufacturing are prohibiting global availability of novel, meaningful therapies. Recently introduced platform approaches, manufacturing technologies, single-use/disposable systems and Process Analytical technology (PAT) have helped to accelerate and de-risk product development and reduce cost of goods (COGS) for commercial products but patient requirements are still not met and affordability of meaningful therapies is still a hurdle for global launches. Digitalisation, automatization, new modalities and novel therapeutic approaches like gene editing and gene therapy are adding complexity but are also offering new opportunities for acceleration of product development and a significant reduction of COGs.

09:10 - 09:50 40 mins
Info
Microbial Manufacturing
Next Generation Biomanufacturing data via data Intergration & Predictive analytics
  • Geoffrey Pot - VP Technical Services, Shire

Availability of clinical trial material meeting all safety and quality relevant parameters is very often the bottleneck for effective and efficient product development at the same time high costs for routine GMP manufacturing are prohibiting global availability of novel, meaningful therapies. Recently introduced platform approaches, manufacturing technologies, single-use/disposable systems and Process Analytical technology (PAT) have helped to accelerate and de-risk product development and reduce cost of goods (COGS) for commercial products but patient requirements are still not met and affordability of meaningful therapies is still a hurdle for global launches. Digitalisation, automatization, new modalities and novel therapeutic approaches like gene editing and gene therapy are adding complexity but are also offering new opportunities for acceleration of product development and a significant reduction of COGs.

09:10 - 09:40 30 mins
Bioanalytical Congress
Method validation based on total error
  • Harry Yang - Senior Director, Head of Statistical Sciences, Medimmune, USA
09:40 - 10:10 30 mins
Info
Bioanalytical Congress
Global regulations for bioanalytical method development and validation
  • Declan Lowney - Associate Director, Janssen
  • What are the expectations of the FDA vs. EMA vs. Asian regulators for method development, validation and transfer?
  • Experiences with meeting global regional regulatory requirements
  • ICH harmonising requirements
  • Sharing strategies used to meet expectations
09:50 - 10:30 40 mins
Info
Continuous Manufacturing
Safeguarding the biomanufacturing supply chain: practical steps to manage raw material and process risks
  • Sofie Stille - GM BioProcess Downstream, GE Healthcare

Biomanufacturing supply chains are growing quickly to service a rapidly expanding industry delivering critical medical products. The increasing demand for often complex raw materials and a limited ability to change approved processes challenge the entire industry to greater focus on strategies to manage raw material variability and its impact on process performance. The presentation will look at our experience managing the quality of complex raw materials, the challenges of securing their supply, which may require multiple sources, and how we can best secure long-term process robustness. In the near term, this is driven by increased focus on supply chain transparency and management, attention to raw material and process analytics and a robust implementation of QBD in both suppliers and drug manufacturers. Longer term, we expect increasing ability to use raw material and process analytical data to better understand how raw materials impact efficiency and quality in biopharmaceutical manufacturing.

09:50 - 10:30 40 mins
Info
Cell Culture & Upstream Process Development
Safeguarding the biomanufacturing supply chain: practical steps to manage raw material and process risks
  • Sofie Stille - GM BioProcess Downstream, GE Healthcare

Biomanufacturing supply chains are growing quickly to service a rapidly expanding industry delivering critical medical products. The increasing demand for often complex raw materials and a limited ability to change approved processes challenge the entire industry to greater focus on strategies to manage raw material variability and its impact on process performance. The presentation will look at our experience managing the quality of complex raw materials, the challenges of securing their supply, which may require multiple sources, and how we can best secure long-term process robustness. In the near term, this is driven by increased focus on supply chain transparency and management, attention to raw material and process analytics and a robust implementation of QBD in both suppliers and drug manufacturers. Longer term, we expect increasing ability to use raw material and process analytical data to better understand how raw materials impact efficiency and quality in biopharmaceutical manufacturing.

09:50 - 10:30 40 mins
Info
Downstream Processing
Safeguarding the biomanufacturing supply chain: practical steps to manage raw material and process risks
  • Sofie Stille - GM BioProcess Downstream, GE Healthcare

Biomanufacturing supply chains are growing quickly to service a rapidly expanding industry delivering critical medical products. The increasing demand for often complex raw materials and a limited ability to change approved processes challenge the entire industry to greater focus on strategies to manage raw material variability and its impact on process performance. The presentation will look at our experience managing the quality of complex raw materials, the challenges of securing their supply, which may require multiple sources, and how we can best secure long-term process robustness. In the near term, this is driven by increased focus on supply chain transparency and management, attention to raw material and process analytics and a robust implementation of QBD in both suppliers and drug manufacturers. Longer term, we expect increasing ability to use raw material and process analytical data to better understand how raw materials impact efficiency and quality in biopharmaceutical manufacturing.

09:50 - 10:30 40 mins
Info
Manufacturing Strategy & Technology
Safeguarding the biomanufacturing supply chain: practical steps to manage raw material and process risks
  • Sofie Stille - GM BioProcess Downstream, GE Healthcare

Biomanufacturing supply chains are growing quickly to service a rapidly expanding industry delivering critical medical products. The increasing demand for often complex raw materials and a limited ability to change approved processes challenge the entire industry to greater focus on strategies to manage raw material variability and its impact on process performance. The presentation will look at our experience managing the quality of complex raw materials, the challenges of securing their supply, which may require multiple sources, and how we can best secure long-term process robustness. In the near term, this is driven by increased focus on supply chain transparency and management, attention to raw material and process analytics and a robust implementation of QBD in both suppliers and drug manufacturers. Longer term, we expect increasing ability to use raw material and process analytical data to better understand how raw materials impact efficiency and quality in biopharmaceutical manufacturing.

09:50 - 10:30 40 mins
Info
Smart Factories
Safeguarding the biomanufacturing supply chain: practical steps to manage raw material and process risks
  • Sofie Stille - GM BioProcess Downstream, GE Healthcare

Biomanufacturing supply chains are growing quickly to service a rapidly expanding industry delivering critical medical products. The increasing demand for often complex raw materials and a limited ability to change approved processes challenge the entire industry to greater focus on strategies to manage raw material variability and its impact on process performance. The presentation will look at our experience managing the quality of complex raw materials, the challenges of securing their supply, which may require multiple sources, and how we can best secure long-term process robustness. In the near term, this is driven by increased focus on supply chain transparency and management, attention to raw material and process analytics and a robust implementation of QBD in both suppliers and drug manufacturers. Longer term, we expect increasing ability to use raw material and process analytical data to better understand how raw materials impact efficiency and quality in biopharmaceutical manufacturing.

09:50 - 10:30 40 mins
Info
Microbial Manufacturing
Safeguarding the biomanufacturing supply chain: practical steps to manage raw material and process risks
  • Sofie Stille - GM BioProcess Downstream, GE Healthcare

Biomanufacturing supply chains are growing quickly to service a rapidly expanding industry delivering critical medical products. The increasing demand for often complex raw materials and a limited ability to change approved processes challenge the entire industry to greater focus on strategies to manage raw material variability and its impact on process performance. The presentation will look at our experience managing the quality of complex raw materials, the challenges of securing their supply, which may require multiple sources, and how we can best secure long-term process robustness. In the near term, this is driven by increased focus on supply chain transparency and management, attention to raw material and process analytics and a robust implementation of QBD in both suppliers and drug manufacturers. Longer term, we expect increasing ability to use raw material and process analytical data to better understand how raw materials impact efficiency and quality in biopharmaceutical manufacturing.

10:10 - 10:40 30 mins
Bioanalytical Congress
Current Analytical Approaches to Biophysical Characterisation in a Regulatory Environment
  • Anshuman Shukla - Principal Scientist - Biophysical Analysis, Intertek
10:40 - 11:20 40 mins
Morning Coffee
11:20 - 11:50 30 mins
Info
Cell Culture & Upstream Process Development
Multivariate analysis of perfusion process data: Insights on process control strategies with respect to product quality
  • Sarantos Kyriakopoulos - MSAT Scientist, Cell Culture, BioMarin International

Multivariate analysis (MVA) is a statistical approach frequently used to generate meaningful information from the vast amount of data recorded from mammalian cell culture. However, the application of MVA is not straightforward, since there are a multitude of approaches and methods that can be used. Here, a novel framework is presented to gain valuable insight on perfusion bioreactor control strategies and how these influence product quality and productivity. Firstly, two-way hierarchical clustering is applied to the process data. This analysis enables the isolation of the intervals that present, statistically, the highest and lowest correlation with process performance indicators (specific productivity, product titre and cumulative daily productivity). For these intervals, the process variables which correlate with the highest and lowest overall productivity are identified and evaluated. The results are subsequently cross-validated using partial least squares (PLS) regression and pairwise correlations. The same workflow is applied for process intervals with high and low product quality. By comparing and contrasting the variables in the two aforementioned workflows, a shortlist of variables is provided that allows to define process control strategies to increase bioreactor productivity, without impacting product quality.

11:20 - 11:50 30 mins
Info
Continuous Manufacturing
Multivariate analysis of perfusion process data: Insights on process control strategies with respect to product quality
  • Sarantos Kyriakopoulos - MSAT Scientist, Cell Culture, BioMarin International

Multivariate analysis (MVA) is a statistical approach frequently used to generate meaningful information from the vast amount of data recorded from mammalian cell culture. However, the application of MVA is not straightforward, since there are a multitude of approaches and methods that can be used. Here, a novel framework is presented to gain valuable insight on perfusion bioreactor control strategies and how these influence product quality and productivity. Firstly, two-way hierarchical clustering is applied to the process data. This analysis enables the isolation of the intervals that present, statistically, the highest and lowest correlation with process performance indicators (specific productivity, product titre and cumulative daily productivity). For these intervals, the process variables which correlate with the highest and lowest overall productivity are identified and evaluated. The results are subsequently cross-validated using partial least squares (PLS) regression and pairwise correlations. The same workflow is applied for process intervals with high and low product quality. By comparing and contrasting the variables in the two aforementioned workflows, a shortlist of variables is provided that allows to define process control strategies to increase bioreactor productivity, without impacting product quality.

11:20 - 11:50 30 mins
Info
Downstream Processing
Protein A comparability and a path to dual sourcing
  • Aled Charles - R&D Manager, Purification Process Sciences, MedImmune

As the bioprocess industry matures, many therapies are coming to market with alternative purification strategies as defined by standardised platform processes. A common factor for all Fc based therapies is the use of Protein A chromatography resins for their resolving power and efficiency compared to non-affinity based processes. Several new resin manufacturers have developed hydroxide stable protein A resins to compete with the established vendors. This has driven suppliers to evolve current offerings in terms of stability, productivity and price. Additional drivers in the industry also require increased security of supply and marketing authorisation holders want operational flexibility to manage inventory and reduce cost.

In this presentation we will address the comparability between Protein A resins on three test molecules to compare key characteristics that could create a plug and play resin environment where dual sourcing of resins could become a reality. We will also highlight strategies for implementing this approach within the product lifecycle where clinical forethought can support long term operating success.

11:20 - 11:50 30 mins
Info
Manufacturing Strategy & Technology
Strategies for aligning Industry 4.0 and a smart manufacturing vision with biopharmaceutical production
  • Samet Yildirim - Manager, Technology & Innovation, Global Technology Management, Boehringer Ingelheim Fremont, Inc.
  • John Levesley - Senior Process Engineer, PM Group
  • Stephen Goldrick - Post-doctoral Researcher, University College London
  • Smart Manufacturing Vision: What is needed to align industry 4.0 and smart manufacturing within the biopharmaceutical sector?
  • Technologies and impact on manufacturing processes
  • Sensor development to handle harsh chemical environments
  • Connectivity: How to reduce waste by connecting all devices in manufacturing?
  • New process platforms, increased intensity for different cell modalities
  • Adapting batch originated biopharmaceutical manufacturing with smart manufacturing vision – Implementing continuous manufacturing for highly autonomous smart facility
  • Applicability of robotics, automation and software platforms in biopharmaceutical manufacturing environment
  • Designing feasible, fully operational smart product agonist facilities
  • Digitalisation initiatives applied in biopharma for process intensification
  • People and digital environment - Identifying the right workforce skill set required for digitalisation and where people are needed in automated field?
  • How can 3D printing be part of disposable processes?
  • Regulatory expectations and requirements for smart factories in the biopharmaceutical sector
11:20 - 11:50 30 mins
Info
Smart Factories
Strategies for aligning Industry 4.0 and a smart manufacturing vision with biopharmaceutical production
  • Samet Yildirim - Manager, Technology & Innovation, Global Technology Management, Boehringer Ingelheim Fremont, Inc.
  • John Levesley - Senior Process Engineer, PM Group
  • Stephen Goldrick - Post-doctoral Researcher, University College London
  • Smart Manufacturing Vision: What is needed to align industry 4.0 and smart manufacturing within the biopharmaceutical sector?
  • Technologies and impact on manufacturing processes
  • Sensor development to handle harsh chemical environments
  • Connectivity: How to reduce waste by connecting all devices in manufacturing?
  • New process platforms, increased intensity for different cell modalities
  • Adapting batch originated biopharmaceutical manufacturing with smart manufacturing vision – Implementing continuous manufacturing for highly autonomous smart facility
  • Applicability of robotics, automation and software platforms in biopharmaceutical manufacturing environment
  • Designing feasible, fully operational smart product agonist facilities
  • Digitalisation initiatives applied in biopharma for process intensification
  • People and digital environment - Identifying the right workforce skill set required for digitalisation and where people are needed in automated field?
  • How can 3D printing be part of disposable processes?
  • Regulatory expectations and requirements for smart factories in the biopharmaceutical sector
11:20 - 11:50 30 mins
Info
Microbial Manufacturing
Approaches for cost efficient inclusion body processes
  • Dr Christian Eichmueller - Head Downstream Process Development, Bioprocess Developmement Kundl, Sandoz GmbH
  • Oliver Spadiut - Assoc. Prof.; Integrated Bioprocess Development, TU Wien
  • Where is, microbial production going?
  • Where do we see microbial hosts in the bioproduction space?
  • What technologies could change the market for microbial production?
  • What technologies and product advances are driving industry away from traditional CHO platforms?
  • Advantages, recent improvements and advances of microbial expression – yeast and E. coli
  • Microbial vs. Mammalian Expression:
  • Titres and Volumes
  • Impurity levels
  • Process timeframes
  • Product quality
  • Scalability
  • Process robustness
  • Tech transfer
  • Cost of Goods/ Production
  • Commercial development and production risk factors
  • Feasibility for integrated end to end continuous biomanufacturing
  • Developing platform approaches
11:20 - 11:50 30 mins
Info
Bioanalytical Congress
Demystifying the USP Chapters on Bioassay Development and Analysis
  • Steven L. Walfish - Principal Scientist and Standards Liaison, USP

USP Chapter <1032>, Design and Development of Bioassay provides a framework for bioassay development, though many of the statistical concepts are not implemented from lack of understanding. This talk will cover the use of different statistical designs and analysis for developing a bioassay that is robust.

11:50 - 12:20 30 mins
Info
Cell Culture & Upstream Process Development
Development of Perfusion Scale-Down Models for Medium Development
  • Amy Johnson - Associate Director, Cell Culture & Media Development, Regeneron Pharmaceuticals Inc.

Due to the complex nature of bioreactor medium, high through-put scale-down models that simulate the perfusion bioreactor system while supporting large multivariate design of experiment approaches are necessary.  For that purpose, two models were developed, optimized, and applied for perfusion medium development. With this first-generation perfusion medium, a cell line developed for fed-batch application achieved over 3-fold increase in productivity.

11:50 - 12:20 30 mins
Info
Continuous Manufacturing
Development of Perfusion Scale-Down Models for Medium Development
  • Amy Johnson - Associate Director, Cell Culture & Media Development, Regeneron Pharmaceuticals Inc.

Due to the complex nature of bioreactor medium, high through-put scale-down models that simulate the perfusion bioreactor system while supporting large multivariate design of experiment approaches are necessary.  For that purpose, two models were developed, optimized, and applied for perfusion medium development. With this first-generation perfusion medium, a cell line developed for fed-batch application achieved over 3-fold increase in productivity.

11:50 - 12:20 30 mins
Info
Downstream Processing
Process development considerations for novel highly potent recombinant proteins
  • David Gruber - Head of Downstream Process Development, Ipsen Biopharm

Botulinum neurotoxin is effective in the treatment of several movement disorders. Native BoNT/A is comprised of a family of highly related neurotoxins produced by Clostridium botulinum bacteria and BoNT/A (subtype A1) is notable as the strain used to produce the commercial products such as abobotulinumtoxinA (Dysport).
An increased understanding of the structure-function relationship of BoNT provides an opportunity to engineer recombinant (r) BoNTs with unique pharmacologic properties and therapeutic applications. This presentation will describe the challenges and opportunities associated with Process Development and GMP manufacture for rBoNT products

11:50 - 12:20 30 mins
Info
Manufacturing Strategy & Technology
Case study Bioplant (UCB, Switzerland), our e-plant setup and future roadmap
  • Anna Marya Jobe - Project Lead, BioPlant Operations, UCB Farchim SA

The Bioplant built in 2013-2015 at the UCB, Bulle site (Switzerland) aimed to be a paperless plant. In order to achieve this many digital systems were put into place and interfaced to each other. As part of our continuous improvement process, other systems/interfaces have been added or are planned. Our e-plant setup and roadmap covers for example: manufacturing control, sampling data management, process data management, scheduling, equipment management.

11:50 - 12:20 30 mins
Info
Smart Factories
Case study Bioplant (UCB, Switzerland), our e-plant setup and future roadmap
  • Anna Marya Jobe - Project Lead, BioPlant Operations, UCB Farchim SA

The Bioplant built in 2013-2015 at the UCB, Bulle site (Switzerland) aimed to be a paperless plant. In order to achieve this many digital systems were put into place and interfaced to each other. As part of our continuous improvement process, other systems/interfaces have been added or are planned. Our e-plant setup and roadmap covers for example: manufacturing control, sampling data management, process data management, scheduling, equipment management.

11:50 - 12:20 30 mins
Info
Microbial Manufacturing
Online monitoring of protein refolding
  • Dr Cécile Brocard - Director Downstream Development, Biopharma Process Science, Boehringer Ingelheim RCV GmbH & Co KG

The need for diversity and flexibility in process development is constantly increasing in the biopharmaceutical industry. Working with microbial expression systems offers low cost and high yield production of non-glycosylated proteins. Exogenous proteins expressed in E. coli are often difficult to produce in other cell types and frequently lead to the formation of inclusion bodies in the bacteria. Although IBs represent an easy-to-harvest source of highly pure recombinant proteins, they are associated with complex purification processes including protein refolding. The complexity relies in the lack of reliable assay to examine the structural steady-state of the target protein. Currently, the most consistent approach to show refolding includes a capture step to evaluate the chromatographic performance of the refolded product. The scale up of refolding as a unit operation can also prove to be a challenging task. Here, we will discuss strategies to monitor the structural changes of a model protein using online sensors.

11:50 - 12:20 30 mins
Info
Bioanalytical Congress
The use of sensitivity analysis to set acceptance criteria in the validation of biomarker assays.
  • Graham Healey - Senior Biostatistician, Oncimmune

In biomarker diagnostic work, an analyte assay may lead to a binary or qualitative outcome such as disease or not-disease, or to-treat or not-to-treat. It is important to know what level of random change in the analytes can be tolerated to guarantee the claimed diagnostic performance. We can define the maximum allowable deviation (MAD) such that the binary endpoint claim is maintained. It can be determined from previously run validation datasets by varying analyte signals in small increments and then creating ruggedness plots. These can then be used to set acceptance limits for validation studies of operational factors. For multi-analyte assays this is not entirely straightforward, but summary measures including logistic regression scores make it possible. It still remains to confirm if such limits are achievable given the underlying variability of the analytes. An accelerated stability example is presented.

12:20 - 12:50 30 mins
Cell Culture & Upstream Process Development
High-Throughput Technology in Process Characterisation and Flexible Manufacturing Solutions to Accelerate Timelines to BLA Filing
  • Kasper Møller - General Manager and Site Head, AGC Biologics
12:20 - 12:50 30 mins
Info
Downstream Processing
Demystifying Extractable Testing
  • Graeme Proctor - Product Manager, single-use technology, Parker Bioscience Division, UK

With single-use technology now at the forefront of existing new and upcoming biopharmaceutical manufacturing processes, the industry is finding that it is playing catch-up with regards to the characterization of single use components through extractable testing. Different approaches to testing have emerged in guidelines from organizations such as BPOG, USP and BPSA but how can the end-user confidently assess and mitigate risk when vendor extractable data is confusing and difficult to compare?

12:20 - 12:50 30 mins
Info
Manufacturing Strategy & Technology
Manufacturing strategy: Designing a Next Generation “Smart” Biomanufacturing Facility
  • Martin G. Smyth, PhD - Global Tech expert, mAb/rhProtein, bioprocess Solutions, Sartorius Stedim UK Ltd
  • Dr. Jim Mills - Senior Vice President – Technical Operations, Abzena

In the biopharmaceutical industry “time to market” is a major driver. An aspect of recent technology development which has shown promise to help address this driver is the use of flexible, single-use manufacturing solutions. These solutions not only decrease or eliminate entirely the time required for production equipment preparation and cleaning, but also significantly decrease the capital investment required for construction of new production plants. IN addition with the adoption of intensified processing further significant productivity gains can be made

During this webinar the design of a state-of-the-art bioproduction plant based on the use of single-use systems throughout the manufacturing process will be described. Particular emphasis will be placed on the flexibility of single-use systems. This will also be explained from the point of view of the contract manufacturing organisation Abzena Overseeing all of these systems is the automation that enables modern process equipment to be operated efficiently in a controlled manner. Sartorius’ approach to automation & analytics with the comprehensive implementation of the Umetrics suite within Abzena’s facilities and how it has been adopted at Abzena will also be described.

12:20 - 12:50 30 mins
Info
Smart Factories
Manufacturing strategy: Designing a Next Generation “Smart” Biomanufacturing Facility
  • Martin G. Smyth, PhD - Global Tech expert, mAb/rhProtein, bioprocess Solutions, Sartorius Stedim UK Ltd
  • Dr. Jim Mills - Senior Vice President – Technical Operations, Abzena

In the biopharmaceutical industry “time to market” is a major driver. An aspect of recent technology development which has shown promise to help address this driver is the use of flexible, single-use manufacturing solutions. These solutions not only decrease or eliminate entirely the time required for production equipment preparation and cleaning, but also significantly decrease the capital investment required for construction of new production plants. IN addition with the adoption of intensified processing further significant productivity gains can be made

During this webinar the design of a state-of-the-art bioproduction plant based on the use of single-use systems throughout the manufacturing process will be described. Particular emphasis will be placed on the flexibility of single-use systems. This will also be explained from the point of view of the contract manufacturing organisation Abzena Overseeing all of these systems is the automation that enables modern process equipment to be operated efficiently in a controlled manner. Sartorius’ approach to automation & analytics with the comprehensive implementation of the Umetrics suite within Abzena’s facilities and how it has been adopted at Abzena will also be described.

12:20 - 12:50 30 mins
Info
Microbial Manufacturing
Latest advancements in producing difficult to express proteins in E. coli
  • Sagrario Arias Rivas - Program Manager & Scientific Liaison, Batavia Biosciences

Full length recombinant antibodies represent one of the fastest growing classes of biopharmaceuticals. The downside is that the manufacturing of these antibodies is expensive, requires extensive production times and yield relatively low product as they are currently made on mammalian cells. Batavia’s SCOPETM microbial fermentation technology is a novel platform for highly controlled regulation of protein expression and high yields in E. coli. This technology allows very cost-effective manufacturing processes for proteins or antibody fragments, which does not require glycosylation. We will present our latest data for the production of a functional scFv antibody fragment.

12:20 - 12:50 30 mins
Info
Bioanalytical Congress
Interlaboratory Performance Metrics from the MAM Consortium New Peak Detection Round Robin Study
  • Richard Rogers - Principal Scientist, Just Biotherapeutics, USA

New peak detection, the purity component of the MAM, ensures novel modifications on biotherapeutics are not overlooked. The MAM consortium has completed a New Peak Detection round robin study. The study had 32 participants from around the world. The NIST mAb was used for the study.   The study included a reference sample, peptide spiked sample, stressed sample, and unknown sample.  Multiple types of mass spectrometers and software packages were evaluated.

12:50 - 13:15 25 mins
Lunch
13:15 - 13:20 5 mins
Info
Live Labs: Meet at the KNect365 Registration Desk

Join the Live Labs tour to gain an insight into some of the most innovative equipment and services to hit today’s biopharmaceutical market.


13:20 - 13:30 10 mins
Info
Live Lab Tour: GE Healthcare

Overcoming today’s bioprocessing challenges – this app can help Modern bioprocessing faces significant challenges including the need for CAPEX investments that ensure process efficiency and speed to market. Meeting these demands requires the right technology from a trusted partner. Join GE Healthcare Life Sciences during the Live Labs Tour and experience a single-use biomanufacturing application that can simplify your journey. Learn about current trends and quickly identify solutions to overcome your specific pain points.

13:30 - 13:40 10 mins
Info
Live Labs Tour: Gyros Protein

Bioprocess development has rapidly evolved to incorporate Quality-by-Design (QbD) principles that depend on deep scientific understanding about each process. Scaled down models and high-capacity testing generates large numbers of samples for analysis, increasing the demand for efficient and timely analytical support to monitor quantity and quality in products and processes.

Gyrolab® xPand provides automation and throughput that enables the rapid and efficient generation of data for large numbers of bioprocess samples. This throughput together with software designed to support bioprocess workflows streamlines and accelerates the implementation of QbD strategies in bioprocess development

13:40 - 13:50 10 mins
Info
Live Lab Tour: Hamilton

Online monitoring of bioprocesses is an important tool in R&D, process development and production and is fundamental for process control. Its foremost advantage is the monitoring of sudden changes of critical process parameters by virtually unlimited sample numbers. 

Hamilton is one of the worldwide leaders in the design and manufacture of process instrumentation. Innovative process sensors are offered for online monitoring of pH, dissolved oxygen and cell density.


During the Live Lab Tour you will learn about the intelligent Arc sensors, the advantages of online cell density monitoring and single use products for upstream processes

13:50 - 14:00 10 mins
Info
Live Lab Tour: Meissner Filtration Products

Meissner’s BioLink™ Modular Overmolding Technology reduces risk in your process by expanding upon the best attributes of conventional overmolding, while incorporating the process flexibility and adaptability of traditional mechanical connections. BioLink™ helps increase fluid path robustness, eliminates manually produced mechanical connections, delivers secure and permanent connectivity to filters and SGTs (singleuse gauge tees), and reduces the total number of fluid contact materials. This presentation will cover the basic BioLink™ components, which include lengths of Meissner’s own proprietary BioFlex® TPE tubing with BioLink™ overmolded unitized end-fittings, and standardized polypropylene modules and filter adaptors that are injection molded out of the same resin as Meissner’s filter product portfolio.

14:00 - 14:10 10 mins
Info
Live Lab Tour: Saint-Gobain - ZERO® Capsule Filters:

Increase yield during filtration processes by eliminating downstream filter holdup. Saint-Gobain’s ZERO® filter capsules are engineered to
reduce liquid hold-up, permitting the maximum amount of valuable process intermediaries and drug product to pass through to downstream processes. These sterilizing-grade Capsule Filters incorporate a patented aseptic recovery port which prevents the loss of liquid held up in the filter without dilution, contamination, or over-pressurization.

14:10 - 14:40 30 mins
Info
Cell Culture & Upstream Process Development
Understanding cell culture media variability
  • Dr. Rui Oliveira - Associate Professor, FCT/UNL
  • Role of trace elements in cell culture performance and product quality
  • How cofactors, lipids, vitamins, etc. affect quality attributes
  • Information about new media that is available
14:10 - 14:40 30 mins
Continuous Manufacturing
Digital transformation and smart biomanufacturing facilities: Case study from Boehringer Ingelheim
  • Samet Yildirim - Manager, Technology & Innovation, Global Technology Management, Boehringer Ingelheim Fremont, Inc.
14:10 - 14:40 30 mins
Info
Downstream Processing
Continuous integrated purification of mAbs: Constant mass flow and alternative technologies.
  • Peter Satzer - Department of Biotechnology, University of Natural Resources and Life Sciences Vienna

Current technologies for continuous mAb purification have a continuous inflow, but a discontinuous outflow. As all continuous downstream steps available for polishing need a constant inflow, steps with discontinuous outflow are impossible to run integrated without surge vessels between steps. Truly integrated unit operations need a constant mass flow in and out from the unit to be truly continuous and to remove all surge and hold tanks in the downstream process (DSP) of the future. We present two unit operations that can be operated continuously without any surge tanks before or after the unit operation: flocculation and precipitation. In line flocculation with the addition of pDADMAC in combination with a tubular reactor for floc development and a parallelized depth filtration for continuous removal of cells was developed and demonstrated on lab scale. With the cells removed, we used a new continuous integrated capture step based on PEG precipitation and continuous microfiltration TFF for precipitate concentration and washing. Yields above 95% were achieved for both unit operations making them viable for industrial application. The flocculation step already removed 99% of the DNA by co-flocculation with the cells reducing the strain on the polishing step, while the PEG based continuous capture removed the majority of host cell proteins. Moreover, precipitation is a unit operation inherently insensitive to changing product concentrations, which simplifies the control strategies significantly. Both unit operations, flocculation and precipitation, are truly continuous, meaning they have a constant mass flow into and out of the unit and can therefore be integrated into any continuous integrated DSP without the need for surge vessels. With new unit operations capable of a constant mass flow through the unit we are one step closer to a truly continuous integrated DSP omitting all hold tanks and surge vessels.


Acknowledgements:

This project has received funding from the European Union's Horizon 2020 research and innovation programme under grant agreement No 635557.

14:10 - 14:40 30 mins
Manufacturing Strategy & Technology
Digital transformation and smart biomanufacturing facilities: Case study from Boehringer Ingelheim
  • Samet Yildirim - Manager, Technology & Innovation, Global Technology Management, Boehringer Ingelheim Fremont, Inc.
14:10 - 14:40 30 mins
Smart Factories
Digital transformation and smart biomanufacturing facilities: Case study from Boehringer Ingelheim
  • Samet Yildirim - Manager, Technology & Innovation, Global Technology Management, Boehringer Ingelheim Fremont, Inc.
14:10 - 14:40 30 mins
Microbial Manufacturing
Approaches for cost efficient inclusion body processes
  • Dr Christian Eichmueller - Head Downstream Process Development, Bioprocess Developmement Kundl, Sandoz GmbH
14:10 - 14:40 30 mins
Bioanalytical Congress
Validation and transfer of analytical methods for biologicals
  • Cyrille C. Chéry - Principal Scientist, UCB
14:40 - 15:10 30 mins
Info
Cell Culture & Upstream Process Development
Using fluorescence spectroscopy for the analysis of raw material and cell culture media variability
  • Alan Ryder - Principal Investigator, NUI Galway

Fluorescence excitation-emission matrix (EEM) spectroscopy offers unique possibilities for the quantitative and qualitative analysis of nearly all types of cell culture media used in the manufacture of biopharmaceuticals.  EEM measurements produce a unique molecular fingerprint for complex biogenic mixtures such as cell culture media that contain multiple fluorophores (e.g. tyrosine, tryptophan, riboflavin, etc. ).  EEM spectra of cell culture media are very sensitive to compositional change, degradation, and improper sample handling.  These effects can be easily identified and quantified using multivariate analysis techniques (chemometrics).  In Galway we have been developing the use of EEM-chemometrics to rapidly and robustly analyse all the various types of cell culture media encountered during manufacturing including raw materials, cell culture media, bioreactor broths, and proteins.  We will illustrate the efficacy of this approach by presenting a wide range of case studies including the analysis of hydrolysate variance, chemically defined media photodamage, variance analysis of basal and feed media, and the analysis of media preparation and filtration methods.  This methodology is suitable for all media types, can also be applied to macromolecule characterisation, and has low capital and unit test costs, making it an ideal PAT tool for bioproduction.

14:40 - 15:10 30 mins
Info
Continuous Manufacturing
Large Scale Single Use Bulk Drug Substance Freeze and Thaw Platform
  • Thomas Hilfer - Senior Scientist, Biologics Engineering, MSD, USA

This presentation is an overview of a novel single use end to end solution for freeze, thaw, handling, and transportation of Bulk Drug Substance. It will touch on topics like points of design consideration, scalability, stability, and proof of concept.

14:40 - 15:10 30 mins
Downstream Processing
Innovative Purification Techniques and Downstream Process Development for Next Generation Therapeutics
  • David O'Connell - Lecturer in Biotherapeutics, School of Biomolecular & Biomedical Science at University College Dublin, Ireland, University College Dublin
14:40 - 15:10 30 mins
Info
Manufacturing Strategy & Technology
Large Scale Single Use Bulk Drug Substance Freeze and Thaw Platform
  • Thomas Hilfer - Senior Scientist, Biologics Engineering, MSD, USA

This presentation is an overview of a novel single use end to end solution for freeze, thaw, handling, and transportation of Bulk Drug Substance. It will touch on topics like points of design consideration, scalability, stability, and proof of concept.

14:40 - 15:10 30 mins
Info
Smart Factories
BioPhorum Single use hardware Plug and Play Initiative
  • Dave Wolton - Operations Consultant, PM Group

The presentation aims to explain why the BioPhorum plug and play initiative is important for the next generation facility. It then seeks to describe how the aggressive timelines are being achieved through focussed teamwork and collaboration across both suppliers and end users. Finally it describes a vision of what the future could hold for automation.

14:40 - 15:10 30 mins
Info
Microbial Manufacturing
How to purify Fabs from "dirty“ E. coli cell lysates?
  • Thomas Gundinger - PhD student, TU Wien

Nowadays the use of microbial expression systems for the production of antibody fragments instead of mammalian cell culture is getting increasingly important. The possibility to produce these highly important proteins by use of “simple” organisms provides several advantages, especially in upstream processing, e.g. short cultivation times as well as high expression rates. However, in most cases subsequent downstream processing of these proteins still represents the main challenge on the way to the final product. Since microbial systems generally do not excrete recombinantly produced proteins, they have to be purified from crude cell lysates after high pressure homogenization. Unfortunately, these lysates do not only contain the desired proteins, but mainly impurities, such as HCPs, DNA and lipids, which cause complications in the purification of the target protein. In my talk, I will show how we tackled this challenge and purified a Fab from E. coli crude cell lysate using different chromatography-based strategies. We developed and investigated an affinity-based as well as a non-affinity-based Fab purification strategy which we compared regarding purification performance (product purity and product recovery) as well as the necessity of pre-treatment of the crude cell lysate for purification. Summarizing, you will learn different possibilities of how to purify a high-value antibody fragment from a “dirty” E. coli crude cell lysate.

14:40 - 15:10 30 mins
Bioanalytical Congress
Implementing bioassays for a kλ-Body
  • Anaëlle Dos Santos - Head of Bioanalytics Unit, Novimmune
15:10 - 15:40 30 mins
Info
Cell Culture & Upstream Process Development
Challenges and opportunities of perfusion cell culture for process intensification and quality improvements
  • Jean-Marc Bielser - Assistant Scientist, BioProcess Science, Merck Serono Switzerland

Scale-down applications of perfusion cell culture are complicated for technical reasons, such as continuous media exchange and cell retention. In this frame, we developed a semi-continuous experiment for screening application, and for the determination of a CSPRmin value. An example with a number of different clones will be presented to illustrate this method. Opportunities of perfusion cell culture will be discussed based on the development of another cell line, expressing a bispecific fusion protein.

15:10 - 15:40 30 mins
Info
Continuous Manufacturing
Challenges and opportunities of perfusion cell culture for process intensification and quality improvements
  • Jean-Marc Bielser - Assistant Scientist, BioProcess Science, Merck Serono Switzerland

Scale-down applications of perfusion cell culture are complicated for technical reasons, such as continuous media exchange and cell retention. In this frame, we developed a semi-continuous experiment for screening application, and for the determination of a CSPRmin value. An example with a number of different clones will be presented to illustrate this method. Opportunities of perfusion cell culture will be discussed based on the development of another cell line, expressing a bispecific fusion protein.

15:10 - 15:40 30 mins
Downstream Processing
Chromatographic Clarification as a Tool to Remove Problematic Host Cell Proteins
  • Dr. Hani El-Sabbahy - Application Engineering Specialist, 3M, UK
15:10 - 15:40 30 mins
Info
Manufacturing Strategy & Technology
Striving for bioprocessing excellence – balancing modern approaches to manufacturing
  • Fredrik Lundström - Product Manager, GE Healthcare, Sweden

With the anticipated growth in diversity of molecules entering the clinical pipeline, and the ever-increasing pressure to improve manufacturing productivity, flexibility, and cost efficiency, there will be a relentless focus on implementing different processing tools and manufacturing approaches to achieve improved process outcomes.

However, there is no silver bullet that can address all types of production scenarios. Instead, effective outcomes can only be achieved through targeted implementation of processing tools. This session will discuss existing and new single-use technologies coming to the market. It will focus on the benefits of choosing each processing tool with the goal of achieving desired outcomes.

15:10 - 15:40 30 mins
Smart Factories
Ramping-up to Maximum Plant Capacity in a Biotech Facility Using Simulation and Scheduling Tools
  • Anna Marya Jobe - Project Lead, BioPlant Operations, UCB Farchim SA
15:10 - 15:40 30 mins
Info
Microbial Manufacturing
Value adding microbial-based solutions for the GMP-production of recombinant proteins
  • Guido Seidel - Managing Director Operations, Wacker Biotech (Operations)

Wacker Biotech, known as THE MICROBIAL CDMO, handles several GMP production sites in Europe with capacities to deliver multiple hundred grams of drug substance per batch. We will present case studies for our innovative and cost-saving E. coli technologies for the production of difficult-to-make biopharmaceuticals. Our approach to process design and problem solving enables our customers to meet their challenging timelines during clinical development as well as to match their needs by reaching the commercial phase.

15:10 - 15:40 30 mins
Info
Bioanalytical Congress
Using a data driven approach to improve biomanufacturing processes
  • Kai Touw - Market Manager (Bio)Pharma, Sartorius Stedim Data Analytics
  • The industry is challenged to improve its manufacturing process robustness and reduce the costs associated with limited process understanding;
  • An increasing range of technical advances becomes available to improve process efficiency;
  • The application of sophisticated PAT tools in combination with multivariate data analytics has a high impact on commercial processing;
  • This presentation gives an insight on how data driven approaches can help to evaluate technological advances to improve production processes.
15:40 - 16:10 30 mins
Afternoon Coffee
16:10 - 16:40 30 mins
Cell Culture & Upstream Process Development
Case Study: Reduction of copper in cell culture media during scale up from 1L to 12000L
  • Dr. Jan Bechmann - Associate Director in cell culture process development, Boehringer Ingelheim Pharma GmbH & Co. KG
16:10 - 16:40 30 mins
Info
Downstream Processing
Alternatives to Protein A for the capture of Fc-containing bispecific antibodies
  • Steven Chamow - Principal, Chamow & Associates, Inc.

Bispecific antibodies (BsAb) are an important new class of protein therapeutics.  BsAb are designed to recognize and bind to two different antigens, often for the purpose of retargeting immune effector cells to kill cancer cells.  Currently two BsAb are approved as therapeutics by EMA and one by FDA.  Using UniRatTM human heavy chain antibody technology, we have produced several BsAb, each targeting a tumor antigen and CD3.  Our lead BsAb are monoclonal IgG4 antibodies engineered in the CH2 and hinge domains to silence Fc-function and prevent arm exchange, respectively.  The molecules comprise 3 chains, two non-identical human heavy chains—one full length, the other derived from the UniRatTM and lacking the CH1 domain. The third is a human kappa light chain bound to the full-length heavy chain.  Correct pairing of heavy chains is achieved through knobs-into-holes technology.  For this and many BsAb, the use of Protein A for capture is problematic due to the presence of Fc-containing product variants in the crude BsAb mixture.  In designing a manufacturing process for BsAb, alternative Fc affinity methods for capture were investigated and a suitable alternative was found.  Properties and performance characteristics of alternative capture methods will be discussed.

16:10 - 16:40 30 mins
Manufacturing Strategy & Technology
Hybrid facilities: Case study on the integration of stainless steel and disposables
  • Ron Bates - Director, Bristol-Myers Squibb
16:10 - 16:40 30 mins
Info
Smart Factories
Towards bioprocess digitalisation through smart supervisory control based on Raman spectroscopy
  • Alessandro Butte - Senior Scientist and Lecturer, ETH Zurich

Within the last years, we elaborated a digitalization platform for bioprocesses in direct collaboration with leading companies for process digitalization, advanced monitoring sensors and cell cultures (Siemens, Kaiser Optical Systems and Merck). The implementation facilitates the handling of process wide information, gained by classical sensors and modern process analyzers like Raman spectroscopy, implemented in upstream and downstream. Furthermore, the platform enables the integration of several developed digital solutions for the analysis, modeling, interpretation, monitoring and control of bioprocesses, embedded in a holistic framework. Those digital solutions are based on advanced engineering statistics, machine learning as well as deterministic approaches, combined in a new generation of models- hybrid bioprocess models. The obtained results demonstrate the high flexibility of statistical models combined with the robustness of deterministic models, leading to a significant reduction of required experiments, while showing a decent prediction accuracy. Moreover, the tools were integrated into the process development workflow in several collaboration projects with the biopharmaceutical industry.

16:10 - 16:40 30 mins
Info
Microbial Manufacturing
Automation and miniaturisation of a microbial fermentation platform for the production of antibody fragments
  • Geoff Brown - Principal Scientist, Upstream Process Sciences, UCB

The benefits of automating and miniaturising our Microbial fermentation process development work include reducing our process development timelines by increasing our throughput and making better use of available resources. This presentation will discuss how the two systems recently implemented in our lab (namely the Ambr250 Modular system from Sartorius and the Freedom Evo 200 from Tecan) are being used to aid our evaluation of process performance and product quality as well as considering future challenges.

16:10 - 16:40 30 mins
Info
Bioanalytical Congress
High-throughput Release N-glycan Method for Product Quality Assessment
  • Vithiya Vimalraj - Senior Scientist, GlaxoSmithKline

N-Glycosylation of biotherapeutics is an important critical quality attribute. Glycans can influence protein stability, serum clearance, immunogenicity and pharmacokinetics. Therefore it is crucial to monitor the full glycan profile of a glycoprotein throughout discovery, clinical and manufacturing phases. A High-throughput RapifluorMS N-glycan method has been employed in our lab to address the challenges that are encountered with product quality support and meet aggressive timelines. This presentation will provide an overview of the development workflow to automate all the steps from sample preparation to data analysis of the RapifluorMS released N-glycan analysis.

16:40 - 17:10 30 mins
Info
Cell Culture & Upstream Process Development
Characterisation of a perfusion-based vaccine production process
  • Perrine Rouel - Upstream Processing Scientist, Janssen Vaccines, The Netherlands

Janssen Vaccines has recently moved towards late stage development and hence characterized its vaccine manufacturing process. The robustness of the perfusion-based process to produce the vaccine at the targeted quality has been demonstrated using Quality by Design (QbD) and a science and risk-based approach.

In this talk, we present how the manufacturing process was characterized at Janssen Vaccines. The presentation focuses on the upstream process characterization: from the criticality assessment through the definition of Proven Acceptable Ranges for each critical USP parameter, including the use of a reduced-scale model.

16:40 - 17:10 30 mins
Continuous Manufacturing
Case Study: Continuous connected downstream processing
  • Luka Jeromel, Lek
16:40 - 17:10 30 mins
Downstream Processing
Case Study: Continuous connected downstream processing
  • Luka Jeromel, Lek
16:40 - 17:10 30 mins
Info
Manufacturing Strategy & Technology
Managing variability and scalability in single use facilities
  • Justyna Adamczyk - Senior Technology Transfer and Process Validation Specialist, Polpharma
  • Adriana Kiędzierska-Mencfeld, PhD - Technical Operations Director, Polpharma Biologics
  • How to deal with scalability in biomanufacturing?
  • How large can you go using single use bioreactors?
  • Linking stainless steel and single use systems for scalable solutions
  • Managing rapid scale up of biomanufacturing
  • Managing variability in biomanufacturing using single use systems
16:40 - 17:10 30 mins
Info
Smart Factories
Applying Raman spectroscopy to the monitoring and control of cell culture processes
  • Carl Rafferty - PhD student, Janssen Sciences Ireland UC

Raman spectroscopy is a tool that is currently at the cutting edge of bioprocess monitoring and control. The principle of this technology is based on the analysis of chemical bond signals generated with a laser. Raman data is harnessed through the use of predictive modeling (Partial Least Squares (PLS)). This presentation is based on research using a Raman spectroscopic probe applied to reduced scale (1L & 5L) and manufacturing scale (2000L) bioreactors to monitor glucose, lactate, ammonia and other cellular process components. The historical cell culture process was limited by the number of data points obtained by daily samples. In the same time frame Raman spectral acquisition can generate up to 95 times more data points for modelled variables compared to daily sampling alone. Experiments were continued at reduced scale (1L) to test the implementation of an automated feedback control loop for the feeding process. The previously gathered Raman spectral data had highlighted fluctuation in glucose control due to the standard process of daily bolus feeding. A low glucose concentration was targeted using the predicted value from Raman spectra obtained in real-time. Each predicted value allowed the automated system to calculate when a volume of feed was to be supplied to the cell culture to maintain the consistent glucose concentration. It resulted in a less variable glucose profile for the process and a 20% increase in biotherapeutic product titer. These findings demonstrated that Raman spectroscopy can be used to increase process visibility of important variables and enabled an automated feeding system to be defined by the setpoint of a critical process variable.

16:40 - 17:10 30 mins
Info
Microbial Manufacturing
Assembling toolboxes, platform technologies and defining workflows for high throughput process development
  • Marco Oldiges - Head of Bioprocesses and Bioanalytical Group, Forschungszentrum Jülich GmbH

Biotechnological production of metabolites and chemicals as well as heterologous protein production using microbial systems is an important field. One important key to success is the increasing speed of genetic manipulations possible for platform organisms like Escherichia coli or Corynebacterium glutamicum and others. This allows engineering microbial strains in a fast way, easily providing large strain libraries.

However, the capability for detailed phenotyping of such libraries at well-defined bioprocess level is orders of magnitude slower and represents a substantial bottleneck in strain engineering and bioprocess development. On top of that, best performing strains need to be identified under process relevant conditions instead of artificial screening conditions.

Miniaturization, parallelization and automation are powerful approaches to increase cultivation throughput in microbial phenotyping, metabolic engineering and bioprocess development. However, to fully release the potential of such approaches, standard and tailor-made automated workflows need to be put in place, comprising the full experimental cultivation pipeline from upstream processing, cultivation, process analytics, data management and design-of-experiment. This is illustrated using case studies with different microbial systems, demonstrating how developments in miniaturized cultivation combined with smart lab automation and data processing are amalgamated in workflows for more efficient microbial phenotyping and bioprocess development.

16:40 - 17:10 30 mins
Info
Bioanalytical Congress
Biotherapeutics Formulation Design in the Age of Lab Automation and Biological Performance Screening
  • Kathrin Schäker-Theobald - Senior Scientist I, NBE HTS Operation & Analytics, AbbVie Deutschland
  • An overlook of the evolution of our automation line addressing scientific as well as data handling matters.
17:10 - 17:40 30 mins
Info
Cell Culture & Upstream Process Development
Providing high biosimilarity by harnessing the analytical technologies during upstream development
  • Duygu Ayyildiz Tamiş - Head of Process Development, Turgut Pharmaceuticals

Consistent high-quality antibody production is a main goal for biosimilar mAb manufacturing. Process variables have high effect on products’ quality in different ways. Here, two case studies are discussed to understand how critical process parameters affect the N-glycan structure of a mAb. To understand the clonal and molecule effects on the N-glycosylation behaviors, two different CHO-M cell clones, producing stable TNF alpha and VEGF blocker monoclonal antibodies, were cultivated in 3-L bioreactors. The impact of feeding strategies, cultivation temperature, culture pH and galactose addition were investigated on glycan pattern and cell behavior in bioreactors. The results showed that temperature effects on G0F-GN and G0F may vary depending on the molecule even the same cell line was used. On the other side, pH had significant effects on fucosylated complexes in both molecules. In order to provide the high biosimilarity in terms of glycosylation and charge variant profiles, process conditions were optimized for both molecules using a variety of different strategies. After providing the high biosimilarity in 3 L bioreactors, a successful scale-up strategy was applied to 200 L GMP production by keeping the products’ quality in critical quality attributes.

17:10 - 17:40 30 mins
Info
Continuous Manufacturing
Advanced Control using Process Analytics for Purification and Particle Engineering
  • Dylan Jones - Development Lead, Sanofi

The development of continuous downstream manufacturing processes is not without its challenges: whether it is finding continuous processing solutions to batch unit operations that are ‘inherently controllable’; designing real-time analytics that can provide timely information of a sufficient quality; or control systems that can handle the complexity. This presentation discusses continuous processing alternatives to chromatography and lyophilisation in DSP - two die-hard batch unit operations - and how we might go about creating automation capable of six sigma levels of control.

17:10 - 17:40 30 mins
Info
Downstream Processing
Advanced Control using Process Analytics for Purification and Particle Engineering
  • Dylan Jones - Development Lead, Sanofi

The development of continuous downstream manufacturing processes is not without its challenges: whether it is finding continuous processing solutions to batch unit operations that are ‘inherently controllable’; designing real-time analytics that can provide timely information of a sufficient quality; or control systems that can handle the complexity. This presentation discusses continuous processing alternatives to chromatography and lyophilisation in DSP - two die-hard batch unit operations - and how we might go about creating automation capable of six sigma levels of control.

17:10 - 17:40 30 mins
Info
Manufacturing Strategy & Technology
The challenges of building high containment facilities
  • Barry Stevenson - Facilities and Technical Support Manager, BioPharmaceutical Development, Ipsen Biopharm

Ipsen Biopharm have invested significantly in the design and build of a state of the art containment suite for the development and manufacture of future pipeline products. This talk will highlight the challenges to overcome when delivering such specialist facilities.

17:10 - 17:40 30 mins
Info
Bioanalytical Congress
Round-Table Discussion: Automating analytical workflows
  • Mario Richter - Principal Scientist DMPK-BA, AbbVie Deutschland GmbH & Co. KG
  • Future focuses
  • Data analysis and evaluation strategies
  • Moving away or moving on to alternatives
  • Strategies to implement automation into existing workflows
17:40 - 18:25 45 mins
Cell Culture & Upstream Process Development
Rosetta - Philae and Hayabusa 2 - MASCOT: Long Term Space Projects with Landers
  • Stephan Ulamec - Philae Project Manager, German Aerospace Center, Germany
17:40 - 18:25 45 mins
Continuous Manufacturing
Rosetta - Philae and Hayabusa 2 - MASCOT: Long Term Space Projects with Landers
  • Stephan Ulamec - Philae Project Manager, German Aerospace Center, Germany
17:40 - 18:25 45 mins
Downstream Processing
Rosetta - Philae and Hayabusa 2 - MASCOT: Long Term Space Projects with Landers
  • Stephan Ulamec - Philae Project Manager, German Aerospace Center, Germany
17:40 - 18:25 45 mins
Manufacturing Strategy & Technology
Rosetta - Philae and Hayabusa 2 - MASCOT: Long Term Space Projects with Landers
  • Stephan Ulamec - Philae Project Manager, German Aerospace Center, Germany
17:40 - 18:25 45 mins
Smart Factories
Rosetta - Philae and Hayabusa 2 - MASCOT: Long Term Space Projects with Landers
  • Stephan Ulamec - Philae Project Manager, German Aerospace Center, Germany
17:40 - 18:25 45 mins
Microbial Manufacturing
Rosetta - Philae and Hayabusa 2 - MASCOT: Long Term Space Projects with Landers
  • Stephan Ulamec - Philae Project Manager, German Aerospace Center, Germany
17:40 - 18:25 45 mins
Bioanalytical Congress
Rosetta - Philae and Hayabusa 2 - MASCOT: Long Term Space Projects with Landers
  • Stephan Ulamec - Philae Project Manager, German Aerospace Center, Germany
18:25 - 20:25 120 mins
End of Day 1 and Evening Entertainment