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Key Sessions

Anthony Mire-Sluis

Technology and Strategies towards the Future Vision of Biomanufacturing

AstraZeneca

Dirk Voelkel

Industry 4.0: Digital Transformation to Tackle Productivity and Growth Challenges

GE Healthcare

07:50 - 09:00

Registration

Showing of Streams
10:30 - 11:20

Morning Coffee and Networking

Showing of Streams
12:50 - 13:20

Lunch in the Exhibition Hall and Live Labs

13:20 - 14:10

Live Labs - Meet at 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.

13.30 Finesse, part of Thermo Fisher Scientific

13.40 GE Healthcare - Reimagine capacity for success MabSelect™PrismA Protein A chromatography resin

13.50 Hamilton

more
Showing of Streams
15:20 - 15:50

Afternoon Coffee

Showing of Streams
16:50 - 17:00

Plenary Change Over

Showing of Streams
17:45 - 17:50
Closing Remarks from the Chair

Closing Remarks from the Chair

17:50 - 19:50

End of Conference Day 1 and Offsite Evening Entertainment. Coaches will depart from outside the Congress Centre between 18:00 and 18:15

07:50 - 09:00 70 mins
Registration
09:00 - 09:10 10 mins
Plenary Session
Chairperson's Opening Remarks
  • Tommy Fanning - Head of Biopharmaceuticals & Food, IDA Ireland
more
09:10 - 09:50 40 mins
Plenary Session
Technology and Strategies towards the Future Vision of Biomanufacturing
  • Anthony Mire-Sluis - Head of Global Quality, AstraZeneca
more

There are multiple areas that can contribute to moving Biomanufacturing forward. These include more on-line and at-line analytical testing, process verification data systems as well as novel process development tools that can result in more robust manufacturing. In addition, facility design, incorporating disposable technology, ‘closed’ manufacturing and modular unit operations can advance manufacturing as can personnel considerations.

09:50 - 10:30 40 mins
Plenary Session
Industry 4.0: Digital Transformation to Tackle Productivity and Growth Challenges
  • Dirk Voelkel - Chief Technology Officer, Innovation and Analytics, GE Healthcare
more

Today, 3 billion people worldwide are connected to the consumer internet. By 2020, 30 billion machines will be connected to the industrial internet and this will transform the way people and machines interact by using data and analytics to drive efficiency, accelerate productivity, and achieve operational excellence. A convergence of trends and technologies are making it possible to realize real benefits.

We will discuss how Industry 4.0 is being used to positively impact the biopharmaceutical industry. In our case studies, we will show how combining brilliant machines with best-in-class digital industrial technologies delivers valuable new insights that were never before possible. We will explore new ways to gain process understanding and prediction through digital platforms that enable customers to realize their QbD strategies. We will share how customers are using Industry 4.0 tools to improve asset understanding aimed at limiting unplanned downtime and improving maintenance cycles. Finally, we will dive into how data science is being used to create digital twins of our processes and to generate valuable insights to support real-time decision-making.

10:30 - 11:20 50 mins
Morning Coffee and Networking
11:20 - 11:40 20 mins
Continuous Manufacturing
Development and Application of a High-Throughput, Plate-Based Method to Measure Resin Binding Capacity: Relevance to Manufacturing Support and Process Development
  • Ronan O’Riordan - Lab Representative, Technical Services/Manufacturing Sciences, Eli Lilly
more
11:20 - 11:40 20 mins
Cell Culture & Upstream Process Development
High-Throughput Automated Mini-Bioreactor (AMBR250™) use for Early Process Development
  • Gerald Boquet - Development Lab Head, Sanofi Research and Development, BioPharmaceutical Process Development
more

The utilisation of automated small scale bioreactor systems represents a promising strategy for early stage process development. Hence, this tool is currently used for different purposes such as clones screening and process development.

One case study of AMBR use for early stage upstream process development is presented. Relevance of AMBR use is then discussed and compared to larger scale bioreactors models.

11:20 - 11:40 20 mins
Manufacturing Strategy & Technology
Strategies and Economics for Designing and Engineering a Flexible Multiproduct Facility
  • Gerald Kierans - Director of Technical Services, Pfizer
more
11:20 - 11:40 20 mins
Downstream Processing
Development and Application of a High-Throughput, Plate-Based Method to Measure Resin Binding Capacity: Relevance to Manufacturing Support and Process Development
  • Ronan O’Riordan - Lab Representative, Technical Services/Manufacturing Sciences, Eli Lilly
more
11:20 - 11:40 20 mins
Microbial Manufacturing
Thought Leaders Discussion: Evaluating Microbial Production Systems
  • Christoph Herwig - Head Biochemical Engineering, Institute of Chemical Engineering, TU Wien, Austria
more
  • Advantages, recent improvements and advances of microbial expression – yeast and E. coli
  • What kind of products can you produce on microbial platforms?
  • Microbial vs. Mammalian Expression:
    • Titres
    • Impurity levels
    • Process timeframes
    • Product quality
    • Scalability
    • Cost of Goods/ Production
    • Commercial development and production risk factors
11:40 - 12:00 20 mins
Continuous Manufacturing
Continuous Downstream Processing: Do We Need To Operate At Steady State?
  • Peter Satzer - Institute of Biotechnology, ACIB, Austrian Centre of Industrial Biotechnology, Austria
more

In batch flocculation and precipitation, the process are run until equilibrium is obtained. In continuous operation, conditions can be chosen before the system is in steady state. This allows a higher flexibility and more room for process control. Examples on continuous antibody purification will be shown.

11:40 - 12:00 20 mins
Cell Culture & Upstream Process Development
High-throughput USP Development including Advanced Microscale Bioreactors (ambr), Cedex Bio HT Analyzer and a Data Acquisition, Management and Analysis System
  • Alina Schneider - Senior Associate, Roche Diagnostics GmbH
more

To enable a high-throughput USP development we implemented a semi-automated workflow to connect ambr® bioreactors (Sartorius, Germany) via a Fluent® pipetting robot (Tecan, Switzerland) to the Cedex Bio HT Analyzer (Roche Diagnostics, Germany) for an accurate sample processing and sophisticated process analytics. Thereby, all systems are integrated in our data acquisition, management and analysis system to ensure an efficient data processing.

11:40 - 12:00 20 mins
Manufacturing Strategy & Technology
An Investigation into Integration of Disposable Components into Traditional Stainless-steel Facilities
  • Mairead Looby - Director, MS&T DS, Bristol-Myers Squibb
more

This presentation will analyse the benefits and limitations associated with the implementation of single-use technology at a large-scale, multi-product commercial manufacturing facility. By integrating single-use components into a stainless steel facility, a hybrid equipment approach enhances manufacturing flexibility while enabling an accelerated manufacturing cadence.

11:40 - 12:00 20 mins
Downstream Processing
Continuous Downstream Processing: Do We Need To Operate At Steady State?
  • Peter Satzer - Institute of Biotechnology, ACIB, Austrian Centre of Industrial Biotechnology, Austria
more

In batch flocculation and precipitation, the process are run until equilibrium is obtained. In continuous operation, conditions can be chosen before the system is in steady state. This allows a higher flexibility and more room for process control. Examples on continuous antibody purification will be shown.

11:40 - 12:00 20 mins
Microbial Manufacturing
Downstream Purification Strategies for Microbial Expressed Proteins
  • Cécile Brocard - Director Downstream Development, Biopharma Process Science, Boehringer Ingelheim RCV GmbH & Co KG
more

We present our holistic approach based on a HTPD toolbox to lever the complexity of manufacturing development for non-platform biotherapeutics. Integration of the whole process chain allows for examination of interdependencies between upstream and downstream development. Our automated screening and optimization unit operations can either be applied as standalone modules or in combination as miniaturized process chain.

12:00 - 12:20 20 mins
Continuous Manufacturing
Accelerating Batch And Continuous Downstream Process Development With The Help Of Modelling And Simulation (M&S) Tools
  • Margit Holzer - Scientific Director and Exclusive Consultant, Ypso-Facto, France
more

Process outlines and definitions are important in the early development phase and give essential information for process design. Process M&S tools can be very helpful in the decision-making process; to save a lot of time, reduce costs and headaches. Later, such tools can support process characterization studies, by simulation of worst case conditions; for example, or help to find quickly the optimal process conditions for scale up. Examples of case studies will illustrate for each process development phase how to use such M&S tools and what are the gains in terms of development time and costs.

12:00 - 12:20 20 mins
Cell Culture & Upstream Process Development
Clone Evaluation based on a Scale-Down System for Perfusion Cultivation
  • Steffen Kreye - USP Development Scientist, Glycotope GmbH, Germany
more
12:00 - 12:20 20 mins
Manufacturing Strategy & Technology
Please move to another stream
12:00 - 12:20 20 mins
Downstream Processing
Accelerating Batch and Continuous Downstream Process Development with The Help of Modelling and Simulation (M&S) Tools
  • Margit Holzer - Scientific Director and Exclusive Consultant, Ypso-Facto, France
more

Process outlines and definitions are important in the early development phase and give essential information for process design. Process M&S tools can be very helpful in the decision-making process; to save a lot of time, reduce costs and headaches. Later, such tools can support process characterization studies, by simulation of worst case conditions; for example, or help to find quickly the optimal process conditions for scale up. Examples of case studies will illustrate for each process development phase how to use such M&S tools and what are the gains in terms of development time and costs.

12:00 - 12:20 20 mins
Microbial Manufacturing
Overcoming the Challenges of Downstream Processing in Microbial Production
  • Gavin Wild - Associate Director, Downstream Process Sciences, UCB, UK
more
12:20 - 12:50 30 mins
Cell Culture & Upstream Process Development
Engineering the Next Generation of CHO Cells
  • Jamie Freeman - Bioproduction Product Manager, Horizon Discovery, UK
more

Aside from single gene knockouts to allow for metabolic selection systems, the CHO host itself remains largely unchanged from that which was used thirty years ago. Here I will present how we have used a combination of techniques including genome engineering approaches such as CRISPR and rAAV to improve the biomanufacturing capacity of our manufacturing ready GS knockout CHO K1 cell line.

12:20 - 12:50 30 mins
Manufacturing Strategy & Technology
Cell Culture Expansions: Looking into the Future
  • Sharyn Farnsworth - Associate Principal Scientist, FUJIFILM Diosynth Biotechnologies
more
  • Choosing best option from several Manufacturing Design Scenarios which include Traditional Facility Augmentation with Single-Use, implement Single-use into Existing Facility or design a facility to highly leverage Single-Use
  • FDB has implemented all three of these scenarios into its facilities leveraging know-how gained from first implementation – case study
  • Maximizing know-how from key suppliers like GE to expedite set up of facility and complete validation
  • Create the next generation of cell culture capacity through partnerships
12:20 - 12:50 30 mins
Downstream Processing
A Novel Approach to Single Use Design and Implementation
  • Graeme Proctor - Product Manager (Single-Use Technologies), Parker
more

Single use assemblies can frequently take in excess of 16 weeks from concept to customer delivery. Challenges around design, customisation, validation and qualification can create delays in implementation and increase time to market. 

Parker will present a novel approach to single use design and implementation, which can dramatically reduce lead times and increase delivery reliability without affecting flexibility or quality.

12:20 - 12:35 15 mins
Microbial Manufacturing
New Solutions for Production of Difficult-to-Express Proteins
  • Guido Seidel - Managing Director Operations, Wacker Biotech GmbH
more

Wacker Biotech will present highly competitive solutions for production of difficult-to-express proteins based on its proprietary E. coli expression systems ESETEC® and FOLDTEC®. Recent case studies will include secretion of functional antibody fragments and enzymes to the fermentation broth with up to 14 g/L. Together with its E. coli refolding platform FOLDTEC®, Wacker Biotech offers a novel and comprehensive approach to rapidly assess manufacturability of therapeutic proteins.

12:50 - 13:20 30 mins
Lunch in the Exhibition Hall and Live Labs
13:20 - 14:10 50 mins
Live Labs - Meet at KNect365 Registration Desk
more

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

13.30 Finesse, part of Thermo Fisher Scientific

13.40 GE Healthcare - Reimagine capacity for success MabSelect™PrismA Protein A chromatography resin

13.50 Hamilton

14:10 - 14:30 20 mins
Continuous Manufacturing
Dynamic Process Control Of An Integrated Downstream Process Using Twin-Column Chromatography
  • Thomas Müller-Späth, ETH Zurich
more

Continuous downstream processing offers large improvements in product quality and production economics. Twin-column periodic counter-current chromatography equipment has become available for both process development and GMP manufacturing scale and has been used for the purification of monoclonal antibodies (mAbs), bispecific antibodies and fusion proteins. Fully continuous end-to-end manufacturing has been achieved coupling continuous upstream with integrated downstream processes.

For robust operation, continuous processes need dynamic process monitoring in view of clinical and commercial manufacturing. This presentation deals with the dynamic UV-based control of an integrated downstream process including a twin-column periodic counter-current capture process (2C-PCC) and two connected single column polishing steps. The dynamic control strategy accounts for changes in resin capacity, titer and adjusts the operating parameters such that capacity utilization and yield are kept constantly at an optimum. The control algorithm and performance data for a 2C-PCC capture process are discussed.

14:10 - 14:30 20 mins
Cell Culture & Upstream Process Development
Process Validation, A Case Study
  • Frédéric Bollin - Bioprocess R&D, Head of Fermentation and Lab Manager, NovImmune SA
more

Process validation is one of the most important steps in the development of a pharmaceutical product.

The aim is to demonstrate the robustness and sustainability of the process, which minimizes the risk of commercial manufacturing batch failure and the variability observed in product quality.

Novimmune has untaken the process characterization for an antibody candidate in readiness for commercial manufacturing. The company qualified an in-house scale-down model of the manufacturing upstream process and performed a risk assessment in order to identify the potentially critical process parameters that have an impact on critical quality attributes of the product in order to secure the safety and efficacy of the drug substance.

The study involved bioreactor evaluations of the process limits for these process parameters and an assessment of their impact on process performance and product quality.

The outcomes of the study provided recommendations for the processing of process performance qualification batches at manufacturing scale.

14:10 - 14:30 20 mins
Downstream Processing
Dynamic Process Control of An Integrated Downstream Process Using Twin-Column Chromatography
  • Thomas Müller-Späth, ETH Zurich
more

Continuous downstream processing offers large improvements in product quality and production economics. Twin-column periodic counter-current chromatography equipment has become available for both process development and GMP manufacturing scale and has been used for the purification of monoclonal antibodies (mAbs), bispecific antibodies and fusion proteins. Fully continuous end-to-end manufacturing has been achieved coupling continuous upstream with integrated downstream processes.

For robust operation, continuous processes need dynamic process monitoring in view of clinical and commercial manufacturing. This presentation deals with the dynamic UV-based control of an integrated downstream process including a twin-column periodic counter-current capture process (2C-PCC) and two connected single column polishing steps. The dynamic control strategy accounts for changes in resin capacity, titer and adjusts the operating parameters such that capacity utilization and yield are kept constantly at an optimum. The control algorithm and performance data for a 2C-PCC capture process are discussed.

14:10 - 14:30 20 mins
Microbial Manufacturing
Production of a Recombinant Periplasmic Protein in E. Coli under Phosphate Limiting Conditions
  • Thomas Gundinger - PhD student - Research Area Biochemical Engineering, Institute of Chemical, Environmental and Biological Engineering, TU Wien, Austria
more

Regulation of expression still describes a main issue in recombinant protein production in E. coli. Most currently used expression systems, such as the T7 system, force unfavourable high expression levels that often cause the formation of undesired insoluble inclusion bodies. In this study we tackled this challenge in several aspects. First of all we compared different genetic constructs to find a suitable system for the recombinant production of a periplasmic protein in a soluble form. To allow the development of a bioprocess with the succeeding system, which was based on phosphate availability, we tested different strategies to monitor the phosphate concentration in the cultivation medium. Finally, having developed an online phosphate monitoring tool, we were able to compare several cultivation strategies and analysed productivity, cell physiology, viability and leakiness. Summarising, we present a holistic success story of how to develop a bioprocess for a soluble periplasmic protein in E. coli - from gene to final cultivation strategy.

14:30 - 14:50 20 mins
Continuous Manufacturing
Expanding Protein Purification Capabilities with Continuous Chromatography
  • Sue Cross, New Medicines UCB
more
14:30 - 14:50 20 mins
Cell Culture & Upstream Process Development
Monitor and Control of Multiple Bioreactor Parameters using In Situ Raman Spectroscopy
  • Mark Czeterko - Staff Engineer, Bioreactor Scale-Up and Development, Regeneron Pharmaceuticals
more

In situ Raman spectroscopy allows bioreactor parameters to be automatically measured online, multiple times per hour, while eliminating the need for sample removal. Raman spectra are used to develop predictive models for real-time measure of cell culture parameters. These models have been employed in development for superior process control of upstream bioprocesses. A case study of our approach will be discussed

14:30 - 14:50 20 mins
Manufacturing Strategy & Technology
Evolution of Large Scale Cell Culture Manufacturing at Bristol-Myers Squibb – Cruiserath MPCC
  • Barak Barnoon - Director Process Engineering, Bristol-Myers Squibb
more

Bristol-Myers Squibb is constructing a large scale multi-product drug substance manufacturing facility in Cruiserath, Dublin. This facility will be reviewed and compared to the company’s other large scale cell culture facility (ca. 2009), to outline some of the lessons learned and the considerations incorporated into the new design to facilitate multi-product flexibility.

14:30 - 14:50 20 mins
Downstream Processing
Expanding Protein Purification Capabilities with Continuous Chromatography
  • Sue Cross, New Medicines UCB
more
14:30 - 14:50 20 mins
Microbial Manufacturing
Manufacture of ImmTacs, Novel Therapies for Cancer
  • Malkit Sami - Head of Process Development and Manufacturing, Immunocore
more

We describe the engineering of ImmTAC (Immune-mobilizing monoclonal TCRs Against Cancer) suitable for use as a therapeutic agent made by refolding inclusion bodies. ImmTACs comprise of a distinct tumour-associated epitope-specific monoclonal TCR with picomolar affinity fused to a humanised anti-CD3 single-chain antibody fragment (scFv), effectively redirected T cells to kill cancer cells expressing extremely low surface epitope densities.

14:50 - 15:20 30 mins
Continuous Manufacturing
Utilising Chromatographic Clarification to Enhance the Performance of Protein A SMB
  • Hani El-Sabbahy - LifeScience Application Engineer, 3M UK & Ireland
more
14:50 - 15:20 30 mins
Cell Culture & Upstream Process Development
Why Outsourcing your Bulk Liquids Preparation Makes Sense
  • Becky Moore - Product Manager, Thermo Fisher Scientific
more

Most bioprocessing facilities consider in-house preparation of buffers and process liquids to be a core bioprocessing task. But did you know that more and more companies are now outsourcing liquid manufacturing, by purchasing pre-prepared materials from vendors or hiring CMOs to prepare these? This area is seeing an increase in outsourced operations because there are bottlenecks in upstream and downstream processing, with buffer volumes often required that can be 10x-20x the volume of the bioreactor used. Making these liquids in-house requires dedicating space, equipment and staff to buffer preparation and handling as well as regulatory oversight, and quality management. An analytical review of the benefits of preparing buffer in-house or outsourcing buffers to a third party will be reviewed, including identifying the total cost, comprised of fixed, variable and consumable costs. Whether you are looking for an economical standard product solution or require a specific custom-designed system, we offer proven bioprocess liquid buffer solutions at every scale. With an expanded global reach and dual sourcing of raw materials, we’re able to leverage economies of scale and access high-quality resources at the best prices—so you can expect more savings on more options.

14:50 - 15:20 30 mins
Manufacturing Strategy & Technology
Modelling and PAT to Support Bioprocess Upstream and Downstream Characterisation and Optimisation
  • Stephen Craven - Team Leader, Large Molecule Process Development, APC Ltd
more
14:50 - 15:20 30 mins
Downstream Processing
Utilising Chromatographic Clarification to Enhance the Performance of Protein A SMB
  • Hani El-Sabbahy - LifeScience Application Engineer, 3M UK & Ireland
more
14:50 - 15:20 30 mins
Microbial Manufacturing
Please move to another stream
15:20 - 15:50 30 mins
Afternoon Coffee
15:50 - 16:10 20 mins
Continuous Manufacturing
Commercialisation of an Integrated Continuous Biomanufacturing Process
  • Franqui Jimenez - Senior Director, Head of Manufacturing Science and Technology, Genzyme, a Sanofi Company
  • Martin Addo - Head of Global Technology Transfer, Sanofi, Ireland
more

This presentation will take place in: Liffey Meeting Room 2

15:50 - 16:10 20 mins
Cell Culture & Upstream Process Development
Rapid Screening of Culture Media Composition using Raman Imaging
  • Steve Hammond - Sr Director/Team Leader, Process Analytical Sciences Group, Pfizer
more

Controlling variation in input materials for upstream Bio-processes is challenging. Often the individual components that are included in the media come from a variety of sources, which introduces variability. The mixing together of over fifty powder ingredients is a significant challenge in all industries, as uniform distribution of all components, particularly the minor components is very challenging.

The conventional testing required to assess whether a vendor is supplying a consistent product, from lot to lot is complex and labour intensive and thus restricts how much resource can be directed at measuring and understanding variation between lot to lot of the important materials.

A new technology, based on Raman imaging has been developed by H2Optix, that enables rapid screening of materials for consistency of composition. This technique is particularly valuable for complex powder blends.

Samples of the blend are dispersed on a sapphire window, and over an hour the Raman camera collects spatially separated spectra of the powder mixture, at a resolution of between 5 and 10microns. This enables identification of the particles in the mixture based on chemical signature, and “mapping” of the size of each particle. In this way the components of the mixtures can be identified, their mass estimated, and a cumulative relative composition calculated. The equipment developed by H2Optix can perform this analysis for multiple samples in an automated fashion, and requires no other laboratory equipment, and little operator intervention.

This presentation will provide a description of this innovative approach to tracking variation in culture media composition.

15:50 - 16:10 20 mins
Manufacturing Strategy & Technology
Commercialisation of an Integrated Continuous Biomanufacturing Process
  • Franqui Jimenez - Senior Director, Head of Manufacturing Science and Technology, Genzyme, a Sanofi Company
  • Martin Addo - Head of Global Technology Transfer, Sanofi, Ireland
more
15:50 - 16:10 20 mins
Downstream Processing
A General Tagless And Traceless Capture Platform for Non-Mab Targets: A Protein A Parallel Based On Self-Cleaving Tags
  • David Wood - Professor of Chemical and Biomolecular Engineering, Ohio State University
more

We have developed a novel system for producing tagless and traceless target proteins from a single affinity capture method. In this system, the target protein is tagged with a short segment of a split intein, which facilitates selective capture and cleavage of the tag on a platform resin. The resulting approach is analogous to Protein A, but for non-mAb targets.

15:50 - 16:10 20 mins
Microbial Manufacturing
A General Tagless And Traceless Capture Platform For Non-Mab Targets: A Protein A Parallel Based On Self-Cleaving TagsA General Tagless And Traceless Capture Platform For Non-Mab Targets: A Protein A Parallel Based On Self-Cleaving Tags
  • David Wood - Professor of Chemical and Biomolecular Engineering, Ohio State University
more

We have developed a novel system for producing tagless and traceless target proteins from a single affinity capture method. In this system, the target protein is tagged with a short segment of a split intein, which facilitates selective capture and cleavage of the tag on a platform resin. The resulting approach is analogous to Protein A, but for non-mAb targets.


This presentation will take place in: Liffey Hall 1

16:10 - 16:30 20 mins
Continuous Manufacturing
Enabling Continuous Manufacturing through Data Science, Modelling and Advanced PAT Tools
  • Christoph Herwig - Head Biochemical Engineering, Institute of Chemical Engineering, TU Wien, Austria
more
  • Continuous manufacturing (CM) is more than the continuous operation of individual process steps.
  • CM needs strategies to link the process steps and to account for variations of the preceding step by the establishment to robust control strategies
  • This contribution provides structured approaches for gathering process understanding for integrated processing, providing this knowledge in form of target oriented minimum models as well as real time solutions to enable model predictive control

This presentation will take place in: Liffey Meeting Room 1

16:10 - 16:30 20 mins
Cell Culture & Upstream Process Development
Methods for Product Quality Monitoring and Controlling Glycosylation
  • Michael Butler - Chief Scientific Officer (CSO), National Institute of Bioprocessing Research & Training (NIBRT), Ireland
more

The profile of glycosylation of a recombinant glycoprotein is generally heterogeneous with respect to occupancy and structural variation.   The challenge in a bioprocess is to control this heterogeneity to ensure consistency and a profile that maximizes the desired biological properties.  The profile can be controlled by cellular glycoengineering, media manipulation or enzymic re-modelling during the downstream process.  Possible strategies for the use of each of these methods will be shown for the production of an antibody. 

16:10 - 16:30 20 mins
Manufacturing Strategy & Technology
Biophorum Operations Group (BPOG) Best Practices Guide for Evaluating Leachables Risk from Polymeric Single-Use Systems Used in Biopharmaceutical Manufacturing
  • Aidan Sexton - Senior Process Validation Engineer, Janssen Sciences Ireland UC
more

The BioPhorum Operations Group (BPOG) is a collaboration of the world’s top manufacturers in the biopharmaceutical manufacturing space. In March 2017 the Extractables and Leachables Work Stream published a best practices guidance document regarding the evaluation of leachables risk for single use components used in biopharmaceutical manufacturing operations. It incorporates a risk based approach, including risk assessment, leachables study design and analytical methods along with other useful information.

16:10 - 16:30 20 mins
Downstream Processing
3D Printed Chromatographic Columns
  • Simone Dimartino - Lecturer in Chemical Engineering, Edinburgh University
more

Improved performances. The design and fabrication of 3D printed columns is described, and chromatographic capture of target proteins directly from fermentation broths is demonstrated. Coupling of this 3D printing technology and continuous manufacturing have the potential to revolutionize the downstream industry.

16:10 - 16:30 20 mins
Microbial Manufacturing
Enabling Continuous Manufacturing through Data Science, Modelling and Advanced PAT Tools
  • Christoph Herwig - Head Biochemical Engineering, Institute of Chemical Engineering, TU Wien, Austria
more
  • Continuous manufacturing (CM) is more than the continuous operation of individual process steps.
  • CM needs strategies to link the process steps and to account for variations of the preceding step by the establishment to robust control strategies
  • This contribution provides structured approaches for gathering process understanding for integrated processing, providing this knowledge in form of target oriented minimum models as well as real time solutions to enable model predictive control
16:30 - 16:50 20 mins
Continuous Manufacturing
Novel Compact Cell Settlers for High Cell Density Perfusion Bioreactor Cultures of Microbial (and Mammalian) Cells
  • Dhinakar Kompala - Founder & CEO, Sudhin Biopharma Company
more

We have scaled up the proven inclined settler technology in a more efficient geometry and demonstrated that this simple technology can now be applied for the smaller, more challenging microbial yeast cells as well. Cell debris and dead yeast cells are removed continuously in the top effluent from our settler while the live and productive cells are recycled to the perfusion bioreactor to achieve and maintain high ODs (>800) for over 2 months. Accumulated protein harvested from the top effluent is about 5x higher than the amount of secreted protein from repeated fed-batch cultures over the same duration.


This presentation will take place in: Liffey Meeting Room 1

16:30 - 16:50 20 mins
Cell Culture & Upstream Process Development
High Throughput and High Automation Tools Coupled with Advanced Knowledge Generation Techniques for Efficient Bioprocess Development
  • Michael Sokolov - Postdoctoral Fellow and Lecturer, ETH Zurich
more
16:30 - 16:50 20 mins
Manufacturing Strategy & Technology
Regulatory Feedback: Practical Advice on GMP Inspections
  • Dearbhla Cullen - Inspector, Health Products Regulatory Authority (HPRA)
more
16:30 - 16:50 20 mins
Downstream Processing
Continuous Manufacturing Strategies – Next-Generation Biopharmaceutical Downstream Process
  • Dejan Arzenšek - Scientist, DSP Development, LEK PHARMACEUTICALS D.D. part of Sandoz division as a NOVARTIS company
more
16:30 - 16:50 20 mins
Microbial Manufacturing
Novel Compact Cell Settlers for High Cell Density Perfusion Bioreactor Cultures of Microbial (and Mammalian) Cells
  • Dhinakar Kompala - Founder & CEO, Sudhin Biopharma Company
more

We have scaled up the proven inclined settler technology in a more efficient geometry and demonstrated that this simple technology can now be applied for the smaller, more challenging microbial yeast cells as well. Cell debris and dead yeast cells are removed continuously in the top effluent from our settler while the live and productive cells are recycled to the perfusion bioreactor to achieve and maintain high ODs (>800) for over 2 months. Accumulated protein harvested from the top effluent is about 5x higher than the amount of secreted protein from repeated fed-batch cultures over the same duration.

16:50 - 17:00 10 mins
Plenary Change Over
17:00 - 17:45 45 mins
Plenary Session
Inspirational Speaker: Feedback from Formula 1- Implementation and Interpretation of Real-Time Analytics and Sensor Technologies
  • Marc Priestley, Former McLaren F1 Pit Crew
more
  • Feedback from Formula 1 on the development of real-time analytics and sensor technologies
  • Translating data generated into real-time decision making

Marc spent ten years as a mechanic on the McLaren Formula One pit crew. Looking at every aspect of F1, he explains the communication, teamwork, pressure and strategy to secure marginal gains. With each car generating 10mb of data per lap, analysts look ever more closely at competitors’ decisions in an effort to optimise their own team performance. Marc also provides insight for Sky Sports, and is part of the ITV team covering the electrically-powered Formula E, showcasing the latest British racing technology.

17:45 - 17:50 5 mins
Closing Remarks from the Chair
17:50 - 19:50 120 mins
End of Conference Day 1 and Offsite Evening Entertainment. Coaches will depart from outside the Congress Centre between 18:00 and 18:15