Agenda
DAY 1 - 28 November 2023
Single Use Technologies
John Moys
Bioprocess Systems Specialist, Repligen Corporation
• Single-use technologies in bioprocessing: how far can they go?
• The shift of the biopharmaceutical industry from traditional stainless-steel
bioprocessing equipment to disposables.
• How can single-use bioprocessing technologies tackle current
bottlenecks?
Evolution of Bioprocessing in Ireland- How It Has Transformed the Irish Biopharma Sector
Matthew Moran
Director, BioPharmaChem 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
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
- 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
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.
LCMS Methods in Biologicals Formulation Development and in Quality Control
Achim Treumann
Director of Analytical Formulation Sciences, Site Head, KBi biopharma BV
• Overview o0f LCMS methods for protein characterization
(intact / bottom up).
• LCMS characterization of proteins in cGMP labs.
• AEX-MS of intact proteins.
One-to -One Meetings & Networking Break
,
Navigating the Global Regulatory Landscape for Cell and Gene Therapies
• Review of the regulatory framework for cell and gene therapies
• Similarities and differences in regulatory requirements across the globe – US, EU, China, Japan etc.
• Development and CMC requirements for BLA
• Regulatory expectations for analytics
• Comparability of manufacturing, process understanding and control requirements
• Regulatory efforts to facilitate the development of cell and gene therapies
Digital Twins for the Acceleration of the Bioproduct Life Cycle
• 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.
Herwig Christoph / Head Research Area Bioprocess Technology / TU WIEN
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
Lunch Time Break
,
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
Process Modeling and Digital Twins to Accelerate Bioprocess Development for New Drugs
• 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
One-to -One Meetings & Networking Break
,
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
Polina Kurbatova / Project Manager – Bioprocess Modelling / Sanofi
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.
Downstream processing
• What is biopharmaceutical downstream processing or DSP?
• What are the steps associated with downstream processing?
• What are the methods used in each downstream processing (DSP) step?
• Process analytical technology (PAT) for downstream processing.
• What is the benefit of PAT for downstream processing (DSP)?
• Techniques for understanding and optimization of downstream processing
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.
Launching the Next Generation of Biologics Manufacturing
David Kolwyck
Director Manufacturing Science - Raw Materials, Biogen Idec
• 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.
Chelation Technology, A Simple and Effective Solution to Remove Copper from CSL's Human Albumin Product
CSL Behring manufactures albumin in various concentrations i.e., 5%, 20% and
25% (commercially named AlbuRx) that serve different medical needs. Interestingly,
the higher concentrations of AlbuRx formulations showed dark sediments at the end
of shelf life. Initial investigations established that copper sulphide (CuS) is the main
component of the dark sediment and that plasma type influences the formation
of sediments, recovered plasma being the worst. Quality by Design (QbD) driven
studies determined a Quality Target for copper at ≤ 0.2mg/kg (≤ 0.8 μg copper/g),
which is expected to significantly delay the formation of dark sediments in long-term
stability studies.
The development work carried out at CSL Behring identified two different methods
to remove copper sulphide sediments i.e.,
1) chelation and sequestration of metal ions by chelating agents followed by
acidification and 2) binding of copper ions by cation exchange resin.
In the first method, a chelation strategy was initially developed with EDTA, but due
to the significant impact on the facility layout related to wastewater treatment for
removal of EDTA, a new biodegradable chelator was introduced named EDDS. It
showed similar efficacy to EDTA at comparable concentrations with a wide pH range
of 4.0 to 4.8. Low pH positively impacted proteolytic activity (PA) and improved
binding capacity, thus preventing the formation of dark sediments. Additionally,
accelerated stability studies demonstrated that treatment with chelators i.e., EDDS
or EDTA (with or without acidification) delayed the formation of dark sediments
significantly as compared to controls. All control lots developed sediments after
approximately 5 months, whereas lots treated with chelators after 11-12 months.
This can be translated to a delay of about 30-42 months in long-term stability
studies, applying factor 5 to accelerated stability studies, where dark sediments were
observed on average 5 times faster.
In summary, a simple method for removing copper ions to prevent the formation of
dark sediments was developed. Efficacy was confirmed by observing a significant
delay in the formation of dark sediments in accelerated stability studies.
Gianluca Dagati / Scientist in Bioprocess development / CSL Behring Bern
Optimizing drug safety and efficacy of complex next-generation biologics
• Challenges in the development of safe biotherapeutics and how to overcome them with a robust analytical strategy.
• Why the transition to biologics like bispecific antibodies, antibody-drug conjugates, and other immunoconjugates?
• What are the challenges associated with developing safe next-gen biologics drugs?
• How can developers tackle these issues and perform an optimal characterization?
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.
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
Viral or Non- viral that is the question for Cell and Gene Therapies
• 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
Lunch Time Break
,
Best Practices for Controlling Contamination in Cell and Gene Therapy Manufacturing Processes
Chris Berridge
Global Technical Consultant, Bioquell Specialist, Ecolab
• Contamination Control Strategy and risk assessment
• Use of closed systems for contamination control
• Approaches for aseptic material transfer in closed systems
Cell and Gene Therapy and Manufacturing
Aoife Duffe / Cell and Gene Therapy Operations Manager / HiTech Health
Development of a Robust Scalable Suspension Platform for AAV Manufacturing
• Turning Hope into reality: intro to Andelyn
• Scalability as an enabler for Gene Therapies
• Scalable suspension platform for AAV manufacturing
Vera Araujo / Senior Director Sales & Strategic Partnerships / Andelyn Biosciences
Impact of Stress Factors on Protein Drug Products
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
One-to -One Meetings & Networking Break
,
,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
ChromNeX, The Better Column. Agile and intensified chromatography
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
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