Agenda
DAY 1 - 28 November 2023
Single use Tangential Flow System Vessel Design and Control Ensures Diafiltration Performance
John Moys
Bioprocess Systems Specialist, Repligen Corporation
• How generic recirculation vessel design can impact performance
• Discussion of the aspects of single use vessel design and control
• Demonstration of how adaptive mixing dynamics ensures diafiltration performance
Evolution of Bioprocessing in Ireland- How It Has Transformed the Irish Biopharma Sector
Rory Mullen
Head of Biopharma and Food, IDA Ireland
• A History of Pharma in Ireland- The Evolution from Small to Large Molecule
• Prioritisation Of Biotech – Technology Foresight Exercise
• Establishment And Support for Bioprocessing Including the Establishment of The National Institute for Bioprocessing Research and Training (Nibrt)
• Growth Of the Sector – Evolution of Large Molecule Drug Substance Facilities
• The Future – Digitisation and Cell and Gene Therapies
Rory Mullen / Head of Biopharma and Food / IDA Ireland
Bioprocessing of Tissue-engineered Organs
Tobias Hedberg
Tissue Engineer, VERIGRAFT
• Bioprocessing of personalized tissue-engineered transplants.
• P-TEV a unique ATMP, from bench to bedside.
• Organ transplantation without the severe risks of immunosuppression.
A Synthetic Biology Approach to make Colour Sustainably by Colorifix
Fernanda Farias
Bioprocess Engineer, Colorifix Limited
• By replacing chemistry dyeing with biology, Colorifix minimises the environmental impact of industrial dyeing at every step of the process,from the creation of the dyes to their fixation onto fabrics.
• The challenges of implementing a bioprocess into an industry that was not yet prepared for it.
• Join us to learn how we are circling back to nature, finding inspiration in its diverse palette yet without harming the environment, compromising on quality, or relying on supply chain availability.
Fernanda Farias / Bioprocess Engineer / Colorifix Limited
High Speed Identification of Superior E. coli Strains for Secretory Production of Target Proteins
Marcel Thön
Senior Expert of Bioprocess Development and Head of “Competence Center for Cell Line Development”, Wacker Biotech GmbH
• Extended screening range for proprietary E. coli ESETEC® strains supported by High-Throughput approach • Micro-scale analysis of product quantitiy and quality
• Assessment of cell lines for optimal fit in large-scale production
• Improved cell line development without increased time investment
Reserved for Wacker Chemie AG
Continuous Flow Pathogen Reduction of Biologics
Trevor Castor
President and CEO, Aphios International
• Utilization of SuperFluids Critical Fluid Inactivation (SFS-CFI), a purely physical method, for the inactivation of viruses and other pathogens.
• Continuous flow processing with reduction of time and mass transfer rates.
• Methods to increase pathogen reduction while minimizing loss in biologic integrity and quantity.
• Exploring the potential for continuous flow pathogen reduction of biologics as well as terminal sterilization of the biologic materials.
One-to -One Meetings & Networking Break
,
LCMS Methods in Biologicals Formulation Development and in Quality Control
Achim Treumann
Head Analytical Product Development, Just-Evotec Biologics France
• Overview o0f LCMS methods for protein characterization
(intact / bottom up).
• LCMS characterization of proteins in cGMP labs.
• AEX-MS of intact proteins.
Digital Twins for the Acceleration of the Bioproduct Life Cycle
Christoph Herwig
Senior Scientific Advisor, Körber Pharma Austria GmbH
• Digital Twins for the acceleration of the bioproduct life cycle
• Digital Twins are vertical replica of the process, the application of digital twins to the product life cycle, hence to development, tech transfer and manufacturing will be discussed
• Offline usage for efficient optimum experimental design
• Real-time usage for prediction of process events and for closed loop control for optimum productivity.
Christoph Herwig / Senior Scientific Advisor / Körber Pharma Austria GmbH
Embracing Digital Transformation in Life Sciences Manufacturing and Processing
Barry Curry
Technical Director, SystemE
• Understanding the real impact of Digital Transformation on your business
• Managing the challenges of Digital Transformation in Life Sciences
• Creating a Digital Transformation roadmap for your business
• Harnessing and measuring the benefits of digitization
Barry Curry / Technical Director / SystemE
Lunch Time Break
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One-to -One Meetings & Networking Break
.
Driving Leapfrog Improvements in Biomanufacturing through Optimization of the Biology
Behzad Mahdavi
Senior Vice President, Biopharma Manufacturing and Life Sciences Tools, Ginkgo Bioworks
• New modalities come with new challenges.
• Limit of operational efficiency, from efficient manufacturing of therapies to manufacturing efficient therapies;
• How to achieve, Case studies.
Chromatography Based PAT Tools for Online Monitoring of CQAs for Timely Process Control
Letha Chemmalil
Scientific Associate Director, Bristol Myers Squibb
• 1D-LC with PSM Autosampler serves as a tool for near-real-time measurements of bioreactor titer, amino acid quantitation and downstream CQA assessments to have a feedback process control
• 2D-LC with integrated inline sampling device enables online monitoring of titer and CQAs directly from bioreactors such that timely control of critical process parameters can be attained to bring the process
in a state of control.
• μSIA system from FIA Labs integrated with inline sampler at the front end and UPLC at the back end serves as a fully automated system or near-real time analysis of complex methods such as N-linked glycan analysis, peptide mapping etc., requiring extensive sample preparation
including sample purification, enzymatic digestion, labelling, solid phase extraction and chromatographic separation
Identifying and Engaging Scientific Experts along the Product Lifecycle
David Kelaher
Chief Medical Officer, Pharmaspectra
• How can a comprehensive scientific and digital data set optimize your
planning across the product life cycle?
• How to leverage the data to better identify and engage scientific experts
• Case study
• Q&A
Bioreactor Digital Twins - From Upstream Process Development to Online Model-based Decision Support Systems
Sarah Fadda
Upstream Bioprocessing Practice Director, Siemens Process Systems Engineering
• Science-based data-calibrated bioreactor models to maximize usage of the existing process knowledge
• Hybrid bioreactor models to address gaps in scientific knowledge instead of replacing mechanistic knowledge
• Whole bioprocess modelling – holistic modelling approach to capture the impact of upstream conditions on the downstream process and implement QbD
• Online decision support modelling systems
One-to -One Meetings & Networking Break
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Process Modeling and Digital Twins to Accelerate Bioprocess Development for New Drugs
Maximilian Krippl
Head of Bioprocess Modeling Consulting, Novasign GmbH
• Increased competition pushes the biopharmaceutical industry to look for novel ways to speed up process development
• Hybrid modeling in combination with dedicated experimental designs are used to describe bioprocesses with a minimum of experiments
• Digital Twins are used to optimize and better understand the influences of CPPs on CQAs in-silico without requiring new experiments
• Showcases for Upstream and Downstream Processing will be presented
Maximilian Krippl / Head of Bioprocess Modeling Consulting / Novasign GmbH
The Viscosity Reduction Platform: How a reduced viscosity can improve process economics in addition to final formulation
Tobias Rosenkranz
Associate Director; Head of Biomolecule Formulation, Merck
• Discuss the impact of high protein viscosity on tangential flow filtration (TFF) and final formulation
• Present case studies showcasing an excipient approach to overcome said challenges
MAM-based Characterization of Biotherapeutics moving into Early Development and PAT
Viktoria Enkmann
Biopharma Specialist, Sciex
• MAM Technology overview
• MAM in Bioprocess Development
• Developability
• MAM for PAT
TFF Model for Vaccine Manufacturing
• Better understanding of the modules
• Facilitate the design of the process and setting up of operating parameters
• Scale-up
• Reducing the number of experiments or support of DOE
3D Printed Chromatography for Intensification of Downstream Processing of Biologics
Sean Feast
CEO, Precision Chroma
• Advantages of 3D printed chromatography columns over traditional resin packed bed columns.
• How 3D printed chromatography can lead to downstream process intensification.
• Scale up of this technology from lab to pilot and beyond.
Bioprocessing Industry 4.0: Delivering Digitalization
• Accelerating Upstream Bioprocess Development Through Data Driven Decisions
• How can digital technology improve bioprocessing and manufacturing?
• What are the challenges and opportunities of digital transformation in manufacturing and processing?
• How to accelerate bioprocess development through digital innovation and data driven decision?
• The evolution of AI– How will artificial intelligence and machine learning help biotech scientists?
Panelists
Barry Curry / Technical Director / SystemE
Sarah Fadda / Upstream Bioprocessing Practice Director / Siemens Process Systems Engineering
Christoph Herwig / Senior Scientific Advisor / Körber Pharma Austria GmbH
DAY 2 - 29 November 2023
CSL112 Process Characterization: A Modern Process Development Approach Implementing QbD Principles
Maria Crespo
Director of Bioprocess Development, CSL Behring
• Implementing QbD principles for a plasma-derived biotherapeutic product.
• Applying a risk- and science-based approach leading to the identification of process parameters potentially impacting quality and performance attributes.
• Sequential DoE approach for process characterization: Pre-screening DoE followed by high resolution DoE.
• Process performance analysis followed by statistical model building and Monte Carlo simulation to predict and minimize defect rate.
• Outcome of process characterization leading to final classification of process parameters together with a thorough process understanding leading to a robust process control strategy.
Accelerating Upstream Process Development with direct CQA and Media Analysis Feedback
Ben Wilkes
European Biopharma Field Marketing Manager, Waters Corporation
Real-time product attribute and spent media information is important to upstream bioprocess optimization, analysis results are often lagging by weeks. Engineers
can now take decisions faster by producing their own at-line quality data, accessible workflows coupling small bioreactors like Sartorius Ambr systems to Waters' BioAccord LC-MS system. Drug quality and yield can be maximized, and downstream impurities minimized. Development is accelerated from weeks to days,
saving resources from multiple optimization cycles.
Accelerated Upstream Bioprocess Development via Integrated LC-MS Analysis – A Case Study on mAbs and CQAs
Ole Wohlenberg
Researcher, Institut für Technische Chemie
Ole Wohlenberg / Researcher / Institut für Technische Chemie
Mid-Infrared Spectroscopy with One-Point Calibration for Upstream and Downstream Processing
Anja Müller
Co-founder and CEO, IRUBIS
• Introduction of mid-infrared spectrometer with single-use flow cell for bioprocessing and one-point calibration to predict process parameters
• Upstream processing: online/inline monitoring of glucose and lactate as well as automated glucose control • Downstream processing: inline monitoring of protein concentration in UF/DF, buffer exchange monitoring
Anja Müller / Co-founder and CEO / IRUBIS
Launching the Next Generation of Biologics Manufacturing
• Key technologies to enable "high intensity" processes with >10g/L titer at commercial scale
• Next generation raw materials receipt and release technologies
• Single Use Technologies for reliable large volume drug substance storage and shipping
• Licensure and approval of inline technologies and digital control loops
Defining Specifications in a Risk-based Control System
Gerald Gellermann
Associate Director, Novartis
Defining limits for analytical method outputs is a central element of a control strategy.
Traditional approaches usually focus on ensuring process consistency, while in more advanced approaches the understanding of structural-function relationships are
utilized. This enables definition of limits that may extend outside those determined by clinical experience. Where indicated, this is required to incorporate more worstcase
assessments to predict future manufacturing variability as the basis to mitigate risks to patients and supply.
One-to -One Meetings & Networking Break
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Important Increase of Expression Level of a BEAT Antibody
Romain Mette
Head of Upstream Process Development, Ichnos Sciences SA
Multispecific format antibodies have a great therapeutic potential. However, they are also known to be a source of challenges in CMC, notably in terms of expression level. At Ichnos, a bispecific antibody in our proprietary BEAT platform was found difficult to express with a titer below 1g/L using the initial platform process. As the initial cell population did not respond to process development, a change of clone was performed, followed by process development in upstream. Among the many tested parameters, a temperature shift was identified as a key factor for titer optimization. Adaptation of the fed-batch process as well as the development of an intensified alternative process helped increasing dramatically the expression level. Such developments will be used to adapt the Ichnos USP platform to support expression of new challenging molecules and formats entering Ichnos’ CMC.
Romain Mette / Head of Upstream Process Development / Ichnos Sciences SA
ChromNeX, The Better Column. Agile and intensified chromatography
Abstract: ChromNeX features a bed supported by an internal lattice structure. This enables a considerable increase in flow rate with no loss of resolution, compared to normal packed column beds. ChromNeX also provides a modular and stackable device design, with prepacked beds of any resin for rapid deployment, ease of use, and enhanced productivity. It is ideal for modern processing. This session will cover the ChromNeX benefits, productivity, and compatibility with existing column-based processes
Guido Stroehlein / Vice President Life Sciences / JSR Life Sciences
Novel PAT Tools in the GMP Space for Biologics in Continuous Manufacturing
Marco Bieri
Senior Scientist, GMP Advanced Analytics Lab, MSD Werthenstein BioPharma
• Implementing Raman based Glucose Control for Perfusion Bioreactor
• Establishing End-to-End automation for Online-LC process monitoring
• Real-time inline concentration measurement with slope spectrophotometry
Marco Bieri / Senior Scientist, GMP Advanced Analytics Lab / MSD Werthenstein BioPharma
Lunch Time Break
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13:55 One-to -One Meetings & Networking Break
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Gene Therapy at the Dawn of a New Era
Farzin Farzaneh
Professor of Molecular Medicine, King’s College London
• Development of programmable vectors with logic-gate based decision making abilities
• The use of such "intelligent", responsive to environmental/physiological cues
• Self-regulation of the therapeutic payload expression
• Development of vectors with inherently responsive safety features,including self-regulated anti-oncogenic features
Cell and Gene Therapy and Manufacturing
Aoife Duffe / Cell and Gene Therapy Operations Manager / HiTech Health
Viral or Non- viral that is the question for Cell and Gene Therapies
Stefano Baila
Managing Director, Eurofins
• Viral vs non- viral for ex-vivo applications
• Critical role of raw material
• Manufacturability and sustainability for cell and gene therapies
Stefano Baila / Managing Director / Eurofins
One-to -One Meetings & Networking Break
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Best Practices for Controlling Contamination in Cell and Gene Therapy Manufacturing Processes
Rolf Hansen
Business Development and Corporate Account Manager, Ecolab
• Contamination Control Strategy and risk assessment
• Use of closed systems for contamination control
• Approaches for aseptic material transfer in closed systems
Rolf Hansen / Business Development and Corporate Account Manager / Ecolab
Cell and Gene Therapy and Manufacturing
• Simplifying cell and gene therapy process.
• Consistency and reproducibility of cell and gene therapy process.
• Reducing cell and gene manufacturing risk.
Aoife Duffe / Cell and Gene Therapy Operations Manager / HiTech Health
HPLC Based High throughput Analysis of Glycans in Cell Line Development
Corinna Ruedi
Analytical Expert, Boehringer Ingelheim
• Glycans and their relevance as product quality attributes in biopharmaceutical products
• Development of a high throughput HPLC based analytical method for non-GMP glycan analysis in the biopharmaceutical product development process
• Application in ranking and selection of clones during early mammalian cell line development and biosimilar / 2nd generation process development
Corinna Ruedi / Analytical Expert / Boehringer Ingelheim
Engineered CHO Cell Lines for Improved Production of Biologics
Bjørn Gunnar Voldborg
Director Cell Line and Protein Production Facility, DTU
• Tailored and defined glycosylation
• Improved bioprocess
• Improved Cell Line Development
• Reduced Host Cell Protein
Bjørn Gunnar Voldborg / Director Cell Line and Protein Production Facility / DTU
Impact of Stress Factors on Protein Drug Products
Twinkle Christian
Principal Scientist, Amgen
A biotherapeutic is exposed to a variety of stress factors throughout its production.The drug manufacturer is responsible to deliver a safe and efficacious product to the patient by maintaining the critical quality attributes of a drug product during manufacture, transport, and use. The scope of this talk is to assess the impact of stress factors faced during process, formulation, packaging, transportation, and handling of drug product quality and discuss appropriate mitigations.
Christian Twinkle / Sr. Scientist / Amgen
Application of Mass Spectrometry and Related Techniques to Complex Protein Therapeutics Product and Process Development – 4-case studies
Qifeng Zhang
Global Senior Principal Scientist, Lonza AG
• KiH fusion Protein 1 with complex glycan profile and unusual PTM
• Fusion Protein 2 with complex glycosylation profile and highly phosphorylated
• Multi-domain fusion Protein 3 liable to fragmentation
• IgG-like bispecific antibody Protein 4 with homodimers and fragments
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