Thursday 20th March - Main Conference Day Two - PT (Pacific Time, GMT-08:00)
- Byron Lee - ,, Sequome
- Nathan Lewis, PhD - Professor, University of California, San Diego
- James Morrissey - ,, Imperial College London
- Victoria Drake Carnein - Upstream Process Development Scientist I, Alexion AstraZeneca Rare Disease
- A Representative - From, Takeda
Poloxamer 188 (P188), an amphiphilic polymer, is widely used for its protective effects on mammalian cells exposed to shear stress in bioreactor environments. These effects arise through both direct intracellular and membrane interactions, as well as indirect extracellular mechanisms, such as bubble coating to mitigate cavitation forces. Recent studies suggest distinct functional differences between commercially available grades of P188 (Kolliphor P188 Bio and Kolliphor P188 Cell Culture), driven by variations in molecular weight distributions. This study investigates the direct effects of bio-grade and cell culture grade P188 on cell membrane properties and metabolism. Our anisotropy analyses indicates that both grades of P188 enhance membrane rigidity, potentially through distinct sphingolipid profiles revealed through lipidomic studies. Cell culture grade P188 upregulates glycerolipids and their precursor, glycerol-3-phosphate, more significantly than bio-grade P188. Differences in ceramide and glycerolipid regulation may correspond to distinct impacts on anti-apoptotic mechanisms and shear stress protection. Indirect effects were studied through growth profile analyses in baffled flasks and fed-batch bioreactors. Culture grade P188 enhanced productivity and showed grade-specific responses to nutrient uptake and shear stress protection. Our findings reveal that different P188 grades exert distinct impacts on both direct and indirect cell culture performance. To optimize bioprotective outcomes, we recommend carefully selecting the appropriate P188 grade based on process conditions, such as micro-sparging and cell line-specific requirements.
- Mahsa Mohiti-Asli, PhD - Biopharma Innovation and Partnership Manager, BASF
- Damien Bellos - Sr. Scientist, Chemistry and Raw Materials, Cytiva
- Mia Wang - Senior Director, CMC Team Leader, Gilead, USA
- Scott Steele - Senior Advisor, CBER, FDA, USA
- Chiali Liu - Senior Director, Drug Substance Development, Teva Pharmaceuticals
- Sabat Gonzalez-Serrano - Graduate Research Associate, The Ohio State University
- Haibin Luo, PhD - Director of Downstream Process Development, BioPharmaceutical Development, AstraZeneca
- Looking at recent FDA disclosures and contamination risks;
- What is the industry doing to work on the need for continuous requalification;
- Looking at performance of the equipment and processes and well as transportation and distribution.
- Jose Vidal - Chief Operating Officer, CytoImmune, USA
- Zheng Zhang - Director, Cell Line Development, BeiGene
- Yashas Rajendra Ph.D. - Director & Principal Scientist, Denali Therapeutics
- Jared Dopp, PhD - Scientist, Upstream Process Development, Bristol-Myers Squibb
To enable electrostatic-steering strategies as a molecular format of multispecifics, Pfizer has developed a co-culture strategy to produce both homodimers in cell culture simultaneously, and subsequently applying the mixture to the redox reaction for heterodimerization during the protein A chromatography unit operation.
Co-culturing introduces exciting new scientific challenges. Careful balancing of cell line performance is needed, as each cell line’s performance during production can greatly impact the excess homodimer impurity profile. Unexpected manufacturing deviations could impact ratio of homodimers produced. These challenges are considered and explored to enable a robust co-culture process, which has been successfully executed for clinical manufacturing.
- Dawn Eriksen-Stapleton, PhD - Principal Scientist, Pfizer
Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.
Contact us today to learn more: Partners@informaconnectls.com
- Bala Reddy - Fonder & Managing Director, Provis Biolabs Pvt Ltd
- Joseph Pekny - Professor, Chemical Engineering, Purdue University
- Case Study
- Madalene Crow - Senior Product Manager, Genentech, USA
- Zheyuan Luo - Scientific Leader, GlaxoSmithKline
- CDMO Landscape:
- Benefits of partnering for facility design, equipment selection, etc.
- Key Selection Criteria:
- Identifying and prioritizing the important factors to consider when selecting a partner within downstream.
- Approaching Tech Transfer and Best Practices;
- Real-world experiences of successful facility fit-outs and collaborations that have led to improved efficiency, reduced costs, and enhanced product quality.
- Shalima Sreenath - Head of Downstream Process Development, Cellibre
- Alpana Naresh, Ph.D. - Executive Director, CMC Operations, Harpoon Therapeutics Inc., a subsidiary of Merck & Co., Inc.
Whether you're increasing your company profile, launching a new product or focusing on new business development opportunities, collaborate with us to identify custom solutions to help you reach your goals.
Contact us today to learn more: Partners@informaconnectls.com
- Loren Wagner - Chief Operations Officer, Poseida Therapeutics, USA
- Manuel Carrondo - Vice-President, Instituto de Biologia Experimental e Tecnológica
- Elizabeth Masterjohn - Scientist, Cell Line Development, Sanofi Genzyme
- Eliot Boulanger - Co-Founder and CEO, Levacells
- Scaling up the production process while maintaining product quality and yield requires careful optimization and validation;
- Ensuring consistent product quality during scale-up is critical. This includes maintaining the same glycosylation patterns, folding, and other quality attributes at larger scales;
- Adhering to Guidelines: Meeting the stringent regulatory requirements for the production of ADCs.
- Mia Wang - Senior Director, CMC Team Leader, Gilead, USA
- Deepti Tanjore - Chief Product Officer, enScale Bio
- Maximilian Krippl - Head of Consulting, Novasign GmbH
- Vaibhav Deokar - Principal Scientist, Lupin Limited (Biotech Division)
- Jian Ren, Ph.D. - Principal Research Scientist I, AbbVie
- Stéphanie Val - Gene Therapy CMC Reviewer, Office of Gene Therapy, Center for Biologics Evaluation and Research, U.S. Food and Drug Administration, USA
- Amy Shaw - Head of Process and Product Development, Cell Therapy Sciences, Takeda, USA
Explore groundbreaking research, meet the poster presenters and BPI Editors, plus find out who has won the poster competition (a free ticket to next year's event!)
*For your poster to be entered into the poster competition, please submit your abstract by 3rd February 2025 and PDF poster by 17th February*
- Zvi Kelman - Director, Biomolecular Labeling Laboratory, NIST
- Shahram Misaghi, PhD - Staff Scientist, Genentech, Inc
- Hiroki Tanemura - Upstream process development researcher, Daiichi Sankyo Co
- A Representative - |, Novartis
- Implementing next-generation technologies, including AI/ML-powered tools, for optimized efficiency;
- How can you seamlessly incorporate technologies?
- Where do we think manufacturing technology is heading in the next 5-10 years?
- Deepti Tanjore - Chief Product Officer, enScale Bio
- Maximilian Krippl - Head of Consulting, Novasign GmbH
- Ramila Peiris - Global Head of Process Data Management, ML and AI Platform, MSAT, Sanofi
- Semsi Ensari - Sr Director, Process Development, Kite Pharma
- Madalene Crow - Senior Product Manager, Genentech, USA
- Abraham Lenhoff - Allan P. Colburn Professor, University of Delaware
- Stefano Menegatti - Associate Professor, North Carolina State University
Talk 1: Driving digital innovation for supply chain orchestration in cell and gene therapy
Christian Fuchs, Head of Orchestration and Exceptions Management for Cell & Gene Therapy (CGT) at Roche/Genentech, USA
Talk 2: Therapeutic epigenome editing: safety and quality considerations of a new class of gene-targeted medicines
Houria Bachtarzi, Principal Consultant, Founding Director, BIOCELLGENE Consulting Ltd, UK
Talk 3: Successfully Implementing Emerging Technologies
Manuel Orsorio, Senior Scientist, Emerging Technologies, CBER, FDA, USA