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

Anthony Mire-Sluis

Technology and Strategies towards the Future Vision of Biomanufacturing

AstraZeneca

Dearbhla Cullen

Regulatory Feedback: Practical Advice on GMP Inspections

Health Products Regulatory Authority (HPRA)

07:50 08:50 (60 mins)

Main agenda

Registration

08:50 09:00 (10 mins)

Main agenda

Chairperson's Opening Remarks

09:00 09:30 (30 mins)

Main agenda

Technology and Strategies towards the Future Vision of Biomanufacturing

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.

  • Anthony Mire-Sluis - Head of Global Quality, AstraZeneca

09:30 10:00 (30 mins)

Main agenda

Next Generation Biomanufacturing and Facility Implementation: Technical Advances in Manufacturing to Improve Process Productivity

  • A Representative, GE Healthcare

10:00 10:40 (40 mins)

Main agenda

Industry 4.0 Thought Leaders Discussion: Biomanufacturing Facilities of the Future and Smart Factories

  • What are the latest technology developments to design smart biomanufacturing facilities of the future?
  • Industry 4.0 and complete digitalised operations and full automation – Are current biopharmaceutical product and processes design fit for being manufactured automatically?
  • How can Internet of Things be applied to biomanufacturing?
  • Where can automation, robotics, AI and virtual reality be applied to biomanufacturing to increase process efficiency?
  • How will these game changing innovations impact biomanufacturing in 5-10 years

10:40 11:20 (40 mins)

Main agenda

Morning Coffee and Networking

11:20 11:40 (20 mins)

Cell Culture & Upstream Process Development

High-Throughput Automated Mini-Bioreactor (AMBR250™) use for Early Process Development

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.

  • Gerald Boquet - Development Lab Head, Sanofi Research and Development, BioPharmaceutical Process Development

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

11:20 11:40 (20 mins)

Microbial Manufacturing

Thought Leaders Discussion: Evaluating Microbial Production Systems

  • 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
  • Christoph Herwig - Head Biochemical Engineering, Institute of Chemical Engineering, TU Wien, Austria
  • Christoph Reese - Director Microbial Fermentation, Roche Diagnostics GmbH, Germany

11:20 11:40 (20 mins)

Downstream Processing

Continuous Manufacturing Strategies – Next-Generation Biopharmaceutical Downstream Process

Nowadays, more and more pharmaceutical companies are focused on development of new biological drugs. Monoclonal antibodies (mAb) are biological drugs that are used for treatment of autoimmune diseases and various types of cancer and represent the biggest group of biologics. Costs of production of new mAb are very high, therefore pharmaceutical industry is searching for new solutions to decrease production costs and development of continuous processes can be one of the solutions.

The aim of the talk will be to present current manufacturing strategies of biologics and approaches, which are being evaluated within next BioPharm DSP project - Next-generation biopharmaceutical downstream process, where the main focus is to develop fully continuous approach for purification of monoclonal antibodies. The specific topics, on which the focus will be on are different approaches for primary separation, such as flocculation or ATF/TFF connected to perfusion, continuous chromatography, several flow-through options for polishing steps and advanced analytical tools, which will enable in-line detection of quality and real time process control.

  • Nebojsa Furlan - Head Laboratory Downstream Development, Novartis Technical Operations

11:20 11:40 (20 mins)

Continuous Manufacturing

Continuous Manufacturing Strategies – Next-Generation Biopharmaceutical Downstream Process

Nowadays, more and more pharmaceutical companies are focused on development of new biological drugs. Monoclonal antibodies (mAb) are biological drugs that are used for treatment of autoimmune diseases and various types of cancer and represent the biggest group of biologics. Costs of production of new mAb are very high, therefore pharmaceutical industry is searching for new solutions to decrease production costs and development of continuous processes can be one of the solutions.

The aim of the talk will be to present current manufacturing strategies of biologics and approaches, which are being evaluated within next BioPharm DSP project - Next-generation biopharmaceutical downstream process, where the main focus is to develop fully continuous approach for purification of monoclonal antibodies. The specific topics, on which the focus will be on are different approaches for primary separation, such as flocculation or ATF/TFF connected to perfusion, continuous chromatography, several flow-through options for polishing steps and advanced analytical tools, which will enable in-line detection of quality and real time process control.

  • Nebojsa Furlan - Head Laboratory Downstream Development, Novartis Technical Operations

11:40 12:00 (20 mins)

Downstream Processing

Continuous Downstream Processing: Do We Need To Operate At Steady State?

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.

  • Alois Jungbauer - Professor, Department of Biotechnology/BOKU and Area Leader Bioprocess Engineering , ACIB, Austrian Centre of Industrial Biotechnology, Austria

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

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.

  • Timo Frensing - Senior Scientist, Large Molecule Research, Roche Diagnostics GmbH

11:40 12:00 (20 mins)

Microbial Manufacturing

Downstream Purification Strategies for Microbial Expressed Proteins

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.

  • Cécile Brocard - Director Downstream Development, Biopharma Process Science, Boehringer Ingelheim RCV GmbH & Co KG

11:40 12:00 (20 mins)

Continuous Manufacturing

Continuous Downstream Processing: Do We Need To Operate At Steady State?

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.

  • Alois Jungbauer - Professor, Department of Biotechnology/BOKU and Area Leader Bioprocess Engineering , ACIB, Austrian Centre of Industrial Biotechnology, Austria

11:40 12:00 (20 mins)

Manufacturing Strategy & Technology

An Investigation into Integration of Disposable Components into Traditional Stainless-steel Facilities

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.

  • Ron Bates - Director, MS&T, Bristol-Myers Squibb

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

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.

  • Margit Holzer - Scientific Director and Exclusive Consultant, Ypso-Facto, France

12:00 12:20 (20 mins)

Cell Culture & Upstream Process Development

High Throughput and High Automation Tools Coupled with Advanced Knowledge Generation Techniques for Efficient Bioprocess Development

Therapeutic proteins feature several dozen critical quality attributes (CQAs) including their glycosylation and charge variant profiles as well as their aggregated and low molecular weight forms, all which are highly important for the efficacy and safety of the drug. For process development a deep understanding of the interrelationship of the potentially influential process parameters and the CQAs is required. Moreover, the dynamic evolution of this interrelationship is of fundamental importance in order to build predictive process models, generate knowledge and provide a solid basis for decision taking.

This work follows the cell culture process development for a biosimilar monoclonal antibody at multiple scales - from screening clones, through process optimization to monitoring of the validated process. It presents the versatile potential of the utilization of high throughput experimental systems such as 96 deep-well plates and ambr-15 bioreactors, highly automated monitoring tools such as Raman spectroscopy and the application of multivariate data analysis. With a particular focus on the product quality, an attractive knowledge management toolbox tailored to the needs of each process development step is presented.

The results are of great importance for academia and industry, as the suggested tools enable to efficiently shape the process towards a well-defined quality goal, to decrease the analytical effort as well as to reduce the risk associated with inaccurate decision taking from complex bioprocess data.

  • Alessandro Butte - Senior Scientist and Lecturer, ETH Zurich

12:00 12:20 (20 mins)

Microbial Manufacturing

Overcoming the Challenges of Downstream Processing in Microbial Production

  • Mariangela Spitali - Director, Head of Downstream Process Sciences Biotech Sciences, TechOps, UCB, UK

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

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.

  • Margit Holzer - Scientific Director and Exclusive Consultant, Ypso-Facto, France

12:00 12:20 (20 mins)

Manufacturing Strategy & Technology

Multi-Product Strategies for Live Virus Drug Product Manufacturing

  • Trent Carrier - Vice President Vaccine Technology & Engineering , Takeda Vaccines, USA

12:20 12:50 (30 mins)

Downstream Processing

Spotlight Presentation: A Representative from Parker

12:20 12:50 (30 mins)

Cell Culture & Upstream Process Development

Spotlight Presentation

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to:

Use an exhibition stand to meet new clients in the main networking area

Raise your corporate profile and shape your corporate image with logo placement

Ensure market presence as a thought leader with a speaking position

For sponsorship and exhibition opportunities please contact: Luke Pickering, Email: luke.pickering@knect365.com

12:20 12:50 (30 mins)

Manufacturing Strategy & Technology

Spotlight Presentation: A Representative from Fujifilm

12:20 12:35 (15 mins)

Microbial Manufacturing

New Solutions for Production of Difficult-to-Express Proteins

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.

  • Guido Seidel - Managing Director Operations, Wacker Biotech GmbH

12:50 14:20 (90 mins)

Main agenda

Lunch in the Exhibition Hall and Live Labs

14:10 14:30 (20 mins)

Manufacturing Strategy & Technology

Evolution of Large Scale Cell Culture Manufacturing at Bristol-Myers Squibb – Cruiserath MPCC

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.

  • Barak Barnoon - Director Process Engineering, Bristol-Myers Squibb

14:10 14:30 (20 mins)

Downstream Processing

Dynamic Process Control of An Integrated Downstream Process Using Twin-Column Chromatography

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.

  • Thomas Müller-Späth, ETH Zurich
  • Massimo Morbidelli - Institute for Chemical and Bioengineering , ETH Zurich, Switzerland

14:10 14:30 (20 mins)

Microbial Manufacturing

Production of a Recombinant Periplasmic Protein in E. Coli under Phosphate Limiting Conditions

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.

  • Thomas Gundinger - Head of Research Area Biochemical Engineering, Institute of Chemical Engineering, TU Wien

14:10 14:30 (20 mins)

Cell Culture & Upstream Process Development

Process Validation, A Case Study

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.


  • Frédéric Bollin - Bioprocess R&D- Associate Upstream Processing Lab Manager, NovImmune SA

14:10 14:30 (20 mins)

Continuous Manufacturing

Dynamic Process Control Of An Integrated Downstream Process Using Twin-Column Chromatography

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.

  • Thomas Müller-Späth, ETH Zurich
  • Massimo Morbidelli - Institute for Chemical and Bioengineering , ETH Zurich, Switzerland

14:30 14:50 (20 mins)

Cell Culture & Upstream Process Development

Monitor and Control of Multiple Bioreactor Parameters using In Situ Raman Spectroscopy

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

  • Mark Czeterko - Staff Engineer, Bioreactor Scale-Up and Development, Regeneron Pharmaceuticals

14:30 14:50 (20 mins)

Downstream Processing

Expanding Protein Purification Capabilities with Continuous Chromatography

  • Sue Cross, New Medicines UCB

14:30 14:50 (20 mins)

Microbial Manufacturing

Manufacture of ImmTacs, Novel Therapies for Cancer

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.

  • Malkit Sami - Head of Process Development and Manufacturing, Immunocore

14:30 14:50 (20 mins)

Continuous Manufacturing

Expanding Protein Purification Capabilities with Continuous Chromatography

  • Sue Cross, New Medicines UCB

14:30 14:50 (20 mins)

Manufacturing Strategy & Technology

Thought Leaders Discussion: Transforming Production Processes and Strategies for Novel, More Complex Products

  • Developing and adapting bioproduction for novel products and therapies
  • Flexible manufacturing, facility capabilities and facility design for smaller volume products: Where is industry going?
  • How to fit manufacturing strategy to local/regional manufacturing?
  • Equipment and assembly vessels required for different volumes of production
  • Adapting single use systems and high throughput development technologies
  • High flexibility of single use systems for small volume products
  • Analytical methods and online monitoring systems for monitoring quality
  • Regulatory pathways and requirements

14:50 15:20 (30 mins)

Cell Culture & Upstream Process Development

Why Outsourcing your Bulk Liquids Preparation Makes Sense

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.

  • Becky Moore - Product Manager, Thermo Fisher Scientific

14:50 15:20 (30 mins)

Manufacturing Strategy & Technology

Spotlight Presentation: A Representative from APC

14:50 15:20 (30 mins)

Downstream Processing

Spotlight Presentation

  • Hani El-Sabbahy - LifeScience Application Engineer, 3M UK & Ireland

14:50 15:20 (30 mins)

Microbial Manufacturing

Spotlight Presentation

Use this event to raise your corporate profile and demonstrate your products and services to our targeted, multidisciplinary audience. By joining us in sponsoring and exhibiting at this event, you will be able to:

Use an exhibition stand to meet new clients in the main networking area

Raise your corporate profile and shape your corporate image with logo placement

Ensure market presence as a thought leader with a speaking position

For sponsorship and exhibition opportunities please contact: Luke Pickering, Email: luke.pickering@knect365.com

14:50 15:20 (30 mins)

Continuous Manufacturing

Spotlight Presentation

  • Hani El-Sabbahy - LifeScience Application Engineer, 3M UK & Ireland

15:20 15:50 (30 mins)

Main agenda

Afternoon Coffee

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

15:50 16:10 (20 mins)

Cell Culture & Upstream Process Development

Rapid Screening of Culture Media Composition using Raman Imaging

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.

  • Steve Hammond - Sr Director/Team Leader, Process Analytical Sciences Group, Pfizer

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

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.

  • David Wood - Professor of Chemical and Biomolecular Engineering, Ohio State University

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

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.

  • David Wood - Professor of Chemical and Biomolecular Engineering, Ohio State University

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

16:10 16:30 (20 mins)

Cell Culture & Upstream Process Development

Methods for Product Quality Monitoring and Controlling Glycosylation

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. 

  • Michael Butler - Chief Scientific Officer (CSO), National Institute of Bioprocessing Research & Training (NIBRT), Ireland

16:10 16:30 (20 mins)

Manufacturing Strategy & Technology

Developing Single Use Technology (SUT) Cell Expansion Process to Improve Cell Culture Processes

  • Jennifer Tengtrakool - Manager, Process Engineering and Development , Sanofi , USA

16:10 16:30 (20 mins)

Microbial Manufacturing

Enabling Continuous Manufacturing through Data Science, Modelling and Advanced PAT Tools

  • 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
  • Christoph Herwig - Head Biochemical Engineering, Institute of Chemical Engineering, TU Wien, Austria

16:10 16:30 (20 mins)

Downstream Processing

3D Printed Chromatographic Columns

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.

  • Simone Dimartino - Lecturer in Chemical Engineering, Edinburgh University

16:10 16:30 (20 mins)

Continuous Manufacturing

Enabling Continuous Manufacturing through Data Science, Modelling and Advanced PAT Tools

  • 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
  • Christoph Herwig - Head Biochemical Engineering, Institute of Chemical Engineering, TU Wien, Austria

16:30 16:50 (20 mins)

Cell Culture & Upstream Process Development

An Upstream Processing Development Case Study with a Focus on Early Stage Process Validation Activities

This presentation will cover the approach taken for the Process Design/Characterisation (Process Validation Stage 1) of a biological product in late stage process development. We will look at the importance of both historical data at production scale and the application of scale down models to determine process robustness prior to Process Qualification (Process Validation Stage 2).

  • Chris Sadler - Senior Manager, Process Science, Allergan Biologics Ltd., an affiliate of Allergan plc

16:30 16:50 (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

16:30 16:50 (20 mins)

Manufacturing Strategy & Technology

Regulatory Feedback: Practical Advice on GMP Inspections

  • Dearbhla Cullen - Inspector, Health Products Regulatory Authority (HPRA)

16:30 16:50 (20 mins)

Microbial Manufacturing

Novel Compact Cell Settlers for High Cell Density Perfusion Bioreactor Cultures of Microbial (and Mammalian) Cells

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.

  • Dhinakar Kompala - Founder & CEO, Sudhin Biopharma Company

16:30 16:50 (20 mins)

Continuous Manufacturing

Novel Compact Cell Settlers for High Cell Density Perfusion Bioreactor Cultures of Microbial (and Mammalian) Cells

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.

  • Dhinakar Kompala - Founder & CEO, Sudhin Biopharma Company

17:00 17:45 (45 mins)

Main agenda

Inspirational Speaker: Feedback from Formula 1- Implementation and Interpretation of Real-Time Analytics and Sensor Technologies

  • 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.

  • Marc Priestley, Former McLaren F1 Pit Crew

17:45 17:50 (5 mins)

Main agenda

Closing Remarks from the Chair

17:50 19:50 (120 mins)

Main agenda

Networking Drinks and Evening Entertainment