Day One (13th May 2025) - CET/CEST (Cent Europe Summer, GMT+2)
- Thomas Jostock, PhD - Associate Director, Novartis
- Shan-Hua Chung - Principal Scientist and Matrix Lead in Cell Technologies, Roche
- Moritz Schmidt - Head of Laboratory Molecular Biology, Boehringer Ingelheim
- Bjarne Rask Poulsen, PhD - Cell Culture Specialist, Novo Nordisk
- Alexander Doerfler - Senior Expert Science and Technology, Biostatistician, Novartis
- A Representative from BioPhorum - -, BioPhorum
- Sebastian Schwaminger - Associate Professor, Medical University of Graz
- Marian Magdy - Department Head Protein Purification, Minapharm Pharmaceuticals
- Christian Witz - CEO, SimVantage GmbH
- Moo Sun Hong - Assistant Professor, Seoul National University
- Ignasi Bofarull-Manzano - Industrial PhD Candidate, CMC Data Scientist and Consultant, RWTH Aachen University, Körber Pharma
- Kat Kozyrytska - Founder, Cell Therapy Manufacturability Program
- Jenny Ann Prange - Head of Production, CTO and Co-founder, MUVON Therapeutics AG
- Vincent Wiegmann - Senior Scientist, MeiraGTx
- Lasse Ebdrup Pedersen - Associate Professor, The Technical University of Denmark
- Lasse Ebdrup Pedersen - Associate Professor, The Technical University of Denmark
- Gearóid Duane - Principal Scientist, Manufacturing Science & Technology Upstream, Bristol Myers Squibb, Cruiserath Biologics
- Imke Vohs - Scientist Engineering USP, MSD
- Fabian Vogt - Head of Laboratory, Boehringer Ingelheim
- Neil Watson - Principal Scientist, UCB
- Jason Beckwith - Research Group Lead, University of Dundee
- Jason Beckwith - Research Group Lead, University of Dundee
Current cell therapy manufacturing sciences are evolving rapidly to enable more reliable and faster scale-up and scale-out of lab-based processes to GMP manufacturing. The key challenge is striking a balance between significantly reducing time-to-market and integrating as many commercialization solutions as possible into the process. In this review, we share key lessons learned from recent engineering and GMP runs, highlighting the impact of automation and process modeling in enhancing readiness for final product supply.
- Amir Goudarzi - Sr. Director, Process Engineering & Technologies, Bayer
- Lior Raviv - Chief Technology Officer, Pluri Biotech Ltd
During sterile drug product manufacturing, aseptic processing is an essential step to helping to ensure safety, purity, and quality of the batch. Sterilizing-grade filters used in the filtration step of aseptic processing must be integrity tested in-line to reduce the risk of contaminating the drug product. Pre-use, post-sterilization integrity testing (PUPSIT) of the sterilizing-grade filters is critical to an effective contamination control strategy as expected [JS1] by European Union (EU) GMP Annex 1 guidelines (Volume 4, Annex 1: Manufacture of Sterile Medicinal Products).
Implementing PUPSIT can introduce additional process challenges if careful design considerations are not made. [JS2] Incorrect installation and operation of PUPSIT systems can cause batch contamination.
With more than 30 years of experience in performing integrity testing as part of a single-use system design[JS3] , Cytiva now offers a simple, ready-to-order solution that is flexible to your process. Our manual and automated PUPSIT solutions include both standardized hardware for consistent installation and standardized consumables. By reducing the risk of incorrect installation and minimizing time to implementation, the manual and automated drug product filtration systems allow you to meet Annex 1 guidelines with ease and confidence.
- Inna Snisarenko - Global Product Manager, Cytiva
- Thomas Jostock, PhD - Associate Director, Novartis
In this presentation we will discuss key aspects related to rAAV production systems' scalability, addressing challenges and future directions for product characterization. Our research lies in improving stable cell line-based production systems for rAAV production. How to optimise the cell line generation process and improve the cell host by CRISPR-Cas9 genetic screen and single cell RNA-seq approaches will be discussed.
- Jose Miguel Escandell Planells - Principal Scientist, iBET - Instituto de Biologia Experimental e Tecnológica
Recombinant protein expression is a highly regulated process consisting of transcription, translation, and protein folding. CHO-based expression often stays challenging for artificial therapeutic proteins, like Bispecific T-cell Engagers (BiTE®) due to reduced productivity compared to monoclonal antibodies. A differentiated insight into the evaluation of expression steps will be given, as well as strategies to find bottlenecks.
- Benedikt Greck - Doctoral Student, Platformization of Complex Molecules, Amgen
- Simon Fradin - Senior Manager / Lab Head Upstream Process Development, Biopharmaceutical Product Development, Fresenius Kabi
This session will interview a member from a sending and receiving site and identify the pain points from both sides that come with transferring technology and processes. How things have changed, and how they will change in an era of digital transformation and an ever increasing need to simplify.
Data lakes, interrogation and digitalization
Leveraging historical data
Skinny process validation
- Patrick Garidel - Head of TIP-PDB, Boehringer Ingelheim Pharma GmbH & Co KG
- Sofia Carvalho - Senior Scientist, iBET
- Christian Witz - CEO, SimVantage GmbH
- Andrej Pohar - Senior Expert Science & Technology, Novartis
- Mark Duerkop - Chief Executive Officer, Novasign, Austria
- Kat Kozyrytska - Founder, Cell Therapy Manufacturability Program
- Lior Shaltiel - CEO, NurExone Biologic
- Tiffany Rau, PhD - Principal Consultant at Biopharma Technical Consulting Ltd & Adjunct Professor Biochemistry and Cell, University College Cork
- Louis Boon, PhD - Chief Scientific Officer and Board Member, JJP Biologics
- Steffen Goletz, PhD - Full Professor, Head of Biotherapeutic Glycoengineering and Immunology - Institute for Biotechnology & Biomedicine, Danish Technical University