Friday 21st March - Main Conference Day Three - PT (Pacific Time, GMT-08:00)
- Landon Mott - Process Development Principal Scientist, Amgen Inc.
- Allyn Spear - Principal Research Scientist, Cell Line Development Lead, Elanco Animal Health
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- Frank Ritacco, PhD - Senior Director, Cell Culture Development, Regeneron
- Maddie Andres - Senior Associate Scientist, Pfizer
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- Semsi Ensari - Sr Director, Process Development, Kite Pharma
- Neal Schilling - Director – Manufacturing, Compass Therapeutics
Innovation to upstream process development has led to higher cell culture titers of biotherapeutics, the increased titer levels have placed a greater challenge to downstream processing to operate more efficiently and reduce cost. To purify increasing amounts of biotherapeutics more efficiently, the use of high flow rates or greater resin-bed heights during downstream chromatography steps is an alluring option. A limitation of increasing chromatography flow rates is the back pressure generated by compression of the packed chromatography resin beds. As chromatography column diameter and resin bed height increases, the resin bed is susceptible to compression that reduces the permeability of the packed resin bed. By providing support of the packed resin bed through control of the hydraulic radius, the permeability of a packed resin bed can be maintained during scale up of the chromatography column. The greater the permeability of a packed resin bed, column pressure-flow dynamics can be improved. Here we introduce OMEGA, a chromatography column insert designed to modulate the hydraulic radius of the column by providing vertical supports through the packed resin bed. Using a commercially available protein A resin, chromatography column performance with and without OMEGA was assessed. OMEGA reduces the effective hydraulic radius of packed columns and increases the permeability of packed resin bed. OMEGA enables higher operational flow rates at increased resin bed height without impact to either dynamic binding capacity or purified product quality. Through the use of OMEGA, scale up hurdles are mitigated, and faster downstream processing times are unlocked across column geometries.
- Romone Fancy, PhD - Process Development Scientist II/Project Leader, Downstream Process Development, KBI BioPharma
- Aishwarya Ramanan - Scientist MSAT Labs & Innovation, Pfizer (Legacy Seagen)
- Stefano Menegatti - Associate Professor, North Carolina State University
- Manuel Carrondo - Vice-President, Instituto de Biologia Experimental e Tecnológica
- Justin Skoble - Vice President, Caribou Biosciences, Inc.
- Jitendra Kumar - Lead Scientist - Chemistry & Process Development, Entos Pharmaceuticals Inc., USA
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.
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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
- Macroeconomic factors: Funding environment and the new US administration
- China
- Capacity concerns in the outsourcing space
- M&A in biopharma and its affect on supplier space
- Wei Wei - Senior Principal Scientist, Pfizer
- Bin Fan, PhD - Director of Biologics, NGM Biopharmaceuticals
HEK293 cells have emerged as a vital platform for producing recombinant therapeutic proteins, primarily due to their ability to closely replicate human post-translational modifications (PTMs). This results in biologically active proteins that are more human-like, offering distinct advantages over alternative production systems. ExcellGene's HEK293Express-based cell lines distinguish themselves with their fast growth, robust characteristics, and high protein yield and functionality, making them attractive choice for large-scale industrial applications.
In this presentation, we will delve into key experiments that have been crucial in optimizing the development of HEKExpress-based cell lines, covering transfection, stable pool selection, and the generation and assessment of stable clones. We will also present case studies that highlight the benefits of utilizing HEKExpress-based cell line development platform at ExcellGene.
- Danijel Svec - Senior Cell Line Development Associate & Project Team Leader, ExcellGene SA
How it will work is we have 3 Round Tables each covering a different Emerging Innovation in Upstream Bioprocessing. Each will be led by an expert. The expert will kick off and guide the discussion which will last for 30 minutes. At the end of the 30 minutes the leader will report their main conclusions to the room for a maximum of 10 minutes.
Continuous and Intensified Processing
- Transitioning from traditional batch to continuous systems.
- Integration with downstream processes.
- Regulatory acceptance and validation hurdles.
- Development of hybrid systems for phased implementation.
- Advances in perfusion systems and single-use bioreactors.
- Widespread adoption in commercial manufacturing.
- Improved efficiency, reduced costs, and faster time to market.
Automation and AI in Cell Culture
- Resistance to adopting AI-driven systems.
- Lack of data standardization and integration.
- Implementation of user-friendly AI tools with robust training programs.
- Standardized data frameworks and digital transformation strategies.
- Collaboration between tech companies and biopharma.
- Fully automated bioprocessing plants.
- Predictive analytics and AI-driven decision-making becoming mainstream.
Cell Line Engineering Advances
- Genetic stability and regulatory concerns with novel cell lines.
- Slow timelines for new cell line development.
- Limited understanding of long-term impacts of gene editing.
- Use of CRISPR and synthetic biology for targeted, efficient modifications.
- High-throughput screening to accelerate selection.
- Emergence of designer cell lines for specific therapies.
- Nathan Lewis, PhD - Professor, University of California, San Diego
- Ken Lee - Director, Bioprocess Technologies and Engineering, BioPharmaceuticals Development, R&D, AstraZeneca
- A Representative - From, Sutro Biopharma, Inc.
- Marshall Ma - Research Fellow, Boston University
- Brian Wong - Associate Director, Cell Culture Media, Upside Foods
- David Wood - Professor of Chemical and Biomolecular Engineering, Ohio State University
- Marion Jenny - MSAT Senior Scientist (DSP), MeiraGTx
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- Dan Oliver - CEO and Founder, Rejuvenate Bio, USA
- Panos Chrysanthopoulos - Chief Development Officer, Morphocell, Canada
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- Macroeconomic factors: Funding environment and the new US administration
- China
- Capacity concerns in the outsourcing space
- M&A in biopharma and its affect on supplier space
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
- Vivek Natarajan - Research Lead, Google Research
- Steven Oh, PhD - Deputy Director, Office of Cellular Therapy and Human Tissue CMC, Office of Therapeutic Products, CBER, FDA