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Key Sessions

Eliana Clark

Biomanufacturing facilities of the future

Biogen

Roman Necina

Next generation biomanufacturing - Enabling accelerated product development and affordable medicines

Shire

Oct 09
Show Filter
07:50 - 09:00

Registration

Showing of Streams
10:40 - 11:20

Morning Coffee

Showing of Streams
12:50 - 14:10

Lunch & Live Labs

Showing of Streams
15:40 - 16:10

Afternoon Coffee

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

End of Day 1 and Evening Entertainment

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
more
09:00 - 09:10 10 mins
Cell Culture & Upstream Process Development
Chairperson's Opening Remarks
  • Tommy Fanning - Head of Biopharmaceuticals & Food, IDA
more
09:00 - 09:10 10 mins
Manufacturing Strategy & Technology
Chairperson's Opening Remarks
  • Tommy Fanning - Head of Biopharmaceuticals & Food, IDA
more
09:00 - 09:10 10 mins
Downstream Processing
Chairperson's Opening Remarks
  • Tommy Fanning - Head of Biopharmaceuticals & Food, IDA
more
09:00 - 09:10 10 mins
Microbial Manufacturing
Chairperson's Opening Remarks
  • Tommy Fanning - Head of Biopharmaceuticals & Food, IDA
more
09:00 - 09:10 10 mins
Smart Factories
Chairperson's Opening Remarks
  • Tommy Fanning - Head of Biopharmaceuticals & Food, IDA
more
09:00 - 09:10 10 mins
Bioanalytical Congress
Chairperson's Opening Remarks
09:10 - 09:40 30 mins
Continuous Manufacturing
Biomanufacturing facilities of the future
  • Eliana Clark - Vice President - International Manufacturing Operations, Biogen
more
09:10 - 09:40 30 mins
Cell Culture & Upstream Process Development
Biomanufacturing facilities of the future
  • Eliana Clark - Vice President - International Manufacturing Operations, Biogen
more
09:10 - 09:40 30 mins
Manufacturing Strategy & Technology
Biomanufacturing facilities of the future
  • Eliana Clark - Vice President - International Manufacturing Operations, Biogen
more
09:10 - 09:40 30 mins
Downstream Processing
Biomanufacturing facilities of the future
  • Eliana Clark - Vice President - International Manufacturing Operations, Biogen
more
09:10 - 09:40 30 mins
Microbial Manufacturing
Biomanufacturing facilities of the future
  • Eliana Clark - Vice President - International Manufacturing Operations, Biogen
more
09:10 - 09:40 30 mins
Smart Factories
Biomanufacturing facilities of the future
  • Eliana Clark - Vice President - International Manufacturing Operations, Biogen
more
09:10 - 09:40 30 mins
Bioanalytical Congress
Method validation based on total error
  • Harry Yang - Senior Director, Head of Statistical Sciences, Medimmune, USA
more
09:40 - 10:10 30 mins
Continuous Manufacturing
Next generation biomanufacturing - Enabling accelerated product development and affordable medicines
  • Roman Necina - SVP Process Science & Technical Operations, Shire
more

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.

09:40 - 10:10 30 mins
Cell Culture & Upstream Process Development
Next generation biomanufacturing - Enabling accelerated product development and affordable medicines
  • Roman Necina - SVP Process Science & Technical Operations, Shire
more

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.

09:40 - 10:10 30 mins
Manufacturing Strategy & Technology
Next generation biomanufacturing - Enabling accelerated product development and affordable medicines
  • Roman Necina - SVP Process Science & Technical Operations, Shire
more

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.

09:40 - 10:10 30 mins
Downstream Processing
Next generation biomanufacturing - Enabling accelerated product development and affordable medicines
  • Roman Necina - SVP Process Science & Technical Operations, Shire
more

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.

09:40 - 10:10 30 mins
Microbial Manufacturing
Next generation biomanufacturing - Enabling accelerated product development and affordable medicines
  • Roman Necina - SVP Process Science & Technical Operations, Shire
more

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.

09:40 - 10:10 30 mins
Smart Factories
Next generation biomanufacturing - Enabling accelerated product development and affordable medicines
  • Roman Necina - SVP Process Science & Technical Operations, Shire
more

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.

09:40 - 10:10 30 mins
Bioanalytical Congress
Global regulations for bioanalytical method development and validation
  • Anne-Marie Murphy - Global Lead, Pfizer
  • Declan Lowney - Associate Director, Janssen
more
  • 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
10:10 - 10:40 30 mins
Continuous Manufacturing
Next generation biomanufacturing and facility implementation: Technical advances in manufacturing technologies to improve process productivity
10:10 - 10:40 30 mins
Cell Culture & Upstream Process Development
Next generation biomanufacturing and facility implementation: Technical advances in manufacturing technologies to improve process productivity
10:10 - 10:40 30 mins
Manufacturing Strategy & Technology
Next generation biomanufacturing and facility implementation: Technical advances in manufacturing technologies to improve process productivity
10:10 - 10:40 30 mins
Downstream Processing
Next generation biomanufacturing and facility implementation: Technical advances in manufacturing technologies to improve process productivity
10:10 - 10:40 30 mins
Microbial Manufacturing
Next generation biomanufacturing and facility implementation: Technical advances in manufacturing technologies to improve process productivity
10:10 - 10:40 30 mins
Smart Factories
Next generation biomanufacturing and facility implementation: Technical advances in manufacturing technologies to improve process productivity
10:10 - 10:40 30 mins
Bioanalytical Congress
Spotlight session
10:40 - 11:20 40 mins
Morning Coffee
11:20 - 11:50 30 mins
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
more

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
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
more

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
Manufacturing Strategy & Technology
Strategies for aligning Industry 4.0 and a smart manufacturing vision with biopharmaceutical production
  • John Levesley - Senior Process Engineer, PM Group
more
  • 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
Downstream Processing
Validation of next gen depth filter technology in a commercial downstream process
  • Kim Hermans - Team Lead MSAT Purification, Sanofi
more
11:20 - 11:50 30 mins
Microbial Manufacturing
Thought leader’s discussion panel: Where is, microbial production going?
more
  • 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
Smart Factories
Strategies for aligning Industry 4.0 and a smart manufacturing vision with biopharmaceutical production
  • John Levesley - Senior Process Engineer, PM Group
more
  • 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
Bioanalytical Congress
Demystifying the USP Chapters on Bioassay Development and Analysis
  • Steven Walfish - Principal Scientist and Standards Liaison, USP
more

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
Continuous Manufacturing
Development of Perfusion Scale-Down Models for Medium Development
  • Amy Johnson - Associate Director, Cell Culture & Media Development, Regeneron Pharmaceuticals Inc.
more

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
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.
more

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
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
more

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
Downstream Processing
Protein A comparability and a path to dual sourcing
  • Aled Charles - R&D Manager, Purification Process Sciences, MedImmune
more
11:50 - 12:20 30 mins
Microbial Manufacturing
Online monitoring of protein refolding
  • Dr Cécile Brocard - Director Downstream Development, Biopharma Process Science, Boehringer Ingelheim RCV GmbH & Co KG
more

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
Smart Factories
Case study Bioplant (UCB, Switzerland), our e-plant setup and future roadmap
  • Anna Marya Jobe - Project Lead, BioPlant Operations, UCB Farchim SA
more

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
Bioanalytical Congress
The use of sensitivity analysis to set acceptance criteria in the validation of biological assays
  • Graham Healey - Senior Biostatistician, Oncimmune
more
12:20 - 12:50 30 mins
Cell Culture & Upstream Process Development
Spotlight presentation: A representative from CMC
12:20 - 12:50 30 mins
Manufacturing Strategy & Technology
Spotlight presentation: A representative from Asahi
12:20 - 12:50 30 mins
Downstream Processing
Spotlight presentation: A representative from Parker
12:20 - 12:50 30 mins
Microbial Manufacturing
Spotlight presentation: A representative from Batavia Biosciences
12:20 - 12:50 30 mins
Smart Factories
Spotlight presentation: A representative from Sartorius
12:20 - 12:50 30 mins
Bioanalytical Congress
Spotlight session
12:50 - 14:10 80 mins
Lunch & Live Labs
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.
more
14:10 - 14:40 30 mins
Cell Culture & Upstream Process Development
Understanding cell culture media variability
  • Rui Oliveira - Associate Professor, FCT/UNL
more
  • 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
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.
more
14:10 - 14:40 30 mins
Downstream Processing
Alternative capture methods for mAbs: crystallisation, flocculation, precipitation, etc.
  • Alois Jungbauer - Professor, University of Natural Resources and Life Sciences Vienna
more
14:10 - 14:40 30 mins
Microbial Manufacturing
Downstream challenges with highly hydrophobic proteins: A case study
  • Dr Christian Eichmueller - Head Downstream Process Development, Bioprocess Developmement Kundl, Sandoz GmbH
more

We will present challenges encountered during the downstream process development for a highly hydrophobic protein expressed as inclusion bodies. Conventional DSP techniques using aqueous buffer systems failed due to limited protein solubility and poor recovery from chromatographic media. While RPC proofed suitable for the capture step, the 2nd orthogonal purification step required a rather unusual cation exchange chromatography with a solvent background.

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.
more
14:10 - 14:40 30 mins
Bioanalytical Congress
Implementing bioassays for a kλ-Body
  • Anaëlle Dos Santos - Head of Bioanalytics Unit, Novimmune
more
14:40 - 15:10 30 mins
Continuous Manufacturing
Establishing fully integrated end to end continuous processing
more
  • Development and implementation of integrated continuous processing
  • Step by step implementation and impact: What is needed for fully integrated continuous systems?
  • Integrating upstream and downstream processing for a continuous approach
  • Update of technology advances to enable integrated continuous bioprocessing
  • Case study transferring from batch to integrated continuous processing to improve productivity
  • Case studies on developing new materials for continuous process lines and fully integrated continuous systems
14:40 - 15:10 30 mins
Cell Culture & Upstream Process Development
Using fluorescence spectroscopy for the analysis of raw material and cell culture media variability: a fast, integrated approach.
  • Alan Ryder - Principal Investigator - Nanoscale Biophotonics, NUI Galway
more

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
Manufacturing Strategy & Technology
Establishing fully integrated end to end continuous processing
more
  • Development and implementation of integrated continuous processing
  • Step by step implementation and impact: What is needed for fully integrated continuous systems?
  • Integrating upstream and downstream processing for a continuous approach
  • Update of technology advances to enable integrated continuous bioprocessing
  • Case study transferring from batch to integrated continuous processing to improve productivity
  • Case studies on developing new materials for continuous process lines and fully integrated continuous systems
14:40 - 15:10 30 mins
Downstream Processing
Alternatives to Protein A for the capture of Fc-containing bispecific antibodies
  • Steven Chamow - Principal, Chamow & Associates, Inc.
more

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.

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

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
Smart Factories
Case study: BPOG Digital Plant Maturity Model (awaiting final confirmation)
14:40 - 15:10 30 mins
Bioanalytical Congress
High-throughput Release N-glycan Method for Product Quality Assessment
  • Vithiya Vimalraj - Associate Scientist, GlaxoSmithKline
more

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.

15:10 - 15:40 30 mins
Cell Culture & Upstream Process Development
Spotlight session
15:10 - 15:40 30 mins
Manufacturing Strategy & Technology
Spotlight presentation: A representative from Sartorius
15:10 - 15:40 30 mins
Downstream Processing
Spotlight session - A representative from 3M
15:10 - 15:40 30 mins
Microbial Manufacturing
Value adding microbial-based solutions for the GMP-production of recombinant proteins
  • Guido Seidel - Managing Director Operations, Wacker Biotech (Operations)
more

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
Smart Factories
Spotlight presentation: A representative from BioProduction Group
15:10 - 15:40 30 mins
Bioanalytical Congress
Spotlight session
15:40 - 16:10 30 mins
Afternoon Coffee
16:10 - 16:40 30 mins
Continuous Manufacturing
Characterisation of a perfusion-based vaccine production process
  • Perrine Rouel - Upstream Processing Scientist, Janssen Vaccines, The Netherlands
more

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.

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

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.

16:10 - 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
more
16:10 - 16:40 30 mins
Downstream Processing
Process development considerations for novel highly potent recombinant proteins - Building the Development Pipeline
  • David Gruber - Head of Downstream Process Development, BioPharmaceutical Development, Ipsen Biopharm
more

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

16:10 - 16:40 30 mins
Microbial Manufacturing
Industry case study: Design and validation of scale down models for process characterisation in microbial manufacturing
16:10 - 16:40 30 mins
Smart Factories
Digital and disruptive technologies in biomanufacturing - Merging classical engineering with smart algorithms
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  • What is a factory in 4.0 looking like?
  • What type of new technologies companies investing in e.g. new reactors, new sensors, new setups of how factories are build e.g. flexible.
  • What is an optimal way to start digitalisation?
  • Do you need to replace all old technologies?
  • How to in bed smart technologies into classical systems?
  • What technology and hardware can be made smart in traditional biomanufacturing factory?
  • Future of hardware – Bedding in smart algorithms into technologies
16:10 - 16:40 30 mins
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
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  • An overlook of the evolution of our automation line addressing scientific as well as data handling matters.
16:40 - 17:10 30 mins
Continuous Manufacturing
Case Study: Continuous connected downstream processing
  • Gorazd Hribar - Project Manager, nextBioPharmDSP, Lek
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16:40 - 17:10 30 mins
Cell Culture & Upstream Process Development
Upstream process development for novel formats
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  • How to apply standard mAb methodologies and technologies to the production of novel formats
  • Difficulties with standard assays and monitoring methods
  • Challenges associated with expression at low titres
16:40 - 17:10 30 mins
Manufacturing Strategy & Technology
Managing variability and scalability in single use facilities
  • Justyna Adamczyk - Senior Technology Transfer and Process Validation Specialist, Polpharma
  • Adriana Kiędzierska-Mencfeld - Head of Production Department, Polpharma Biologics
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  • 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
Downstream Processing
Case Study: Continuous connected downstream processing
  • Gorazd Hribar - Project Manager, nextBioPharmDSP, Lek
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16:40 - 17:10 30 mins
Microbial Manufacturing
Automation and miniaturisation of a microbial fermentation platform for the production of antibody fragments
  • Geoff Brown - Principal Scientist, Upstream Process Sciences, UCB
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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.

16:40 - 17:10 30 mins
Smart Factories
Towards bioprocess digitalisation through smart supervisory control based on Raman spectroscopy
  • Alessandro Butte - Senior Scientist and Lecturer, ETH Zurich
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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.

16:40 - 17:10 30 mins
Bioanalytical Congress
Round-Table Discussion: Automating analytical workflows
  • Mario Richter - Principal Scientist DMPK-BA, AbbVie Deutschland GmbH & Co. KG
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  • Future focuses
  • Data analysis and evaluation strategies
  • Moving away or moving on to alternatives
  • Strategies to implement automation into existing workflows
17:10 - 17:40 30 mins
Continuous Manufacturing
Advanced Control using Process Analytics for Purification and Particle Engineering
  • Dylan Jones - Development Lead, Sanofi
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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
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
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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
Manufacturing Strategy & Technology
The challenges of building high containment facilities
  • Barry Stevenson - Facilities and Technical Support Manager, BioPharmaceutical Development, Ipsen Biopharm
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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
Downstream Processing
Advanced Control using Process Analytics for Purification and Particle Engineering
  • Dylan Jones - Development Lead, Sanofi
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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
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
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17:10 - 17:40 30 mins
Smart Factories
Utilisation of AI and IOT in data driven biopharmaceutical manufacturing decision making
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  • How does the IOT and 4.0 direct better decisions?
  • Smart biomanufacturing using data driven decisions from IOT
  • Utilisation of AI systems and process development and supply chain data to aid data driven decision making
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
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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
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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
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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
more
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
more
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
more
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
more
18:25 - 20:25 120 mins
End of Day 1 and Evening Entertainment