Aseptic Risks, CDMO Selection, and CRISPR RNPs
Cell & Gene
The most valuable resource for professionals who make their living in the cell & gene therapies industry.
TRENDING CONTENT - Catch Up
Anne Lamontagne and Wendy Liang at Dark Horse Consulting Group Inc. provide expert analysis of the FDA 's final guidance for CAR T cell products, addressing key considerations for developers. Notable updates include emphasis on oncology and manufacturing methods.
Establishing a robust contamination control strategy for ATMPs is of utmost importance. We must employ risk assessments and risk-based approaches. In this article, Darius Pillsbury and Tiffany Baker, MBA from ValSource Inc. introduce the aseptic risk evaluation model (AREM), which is compliant with the evolving global regulatory landscape and best practices.
In this Q&A interview, Ann Rossi Bilodeau from Corning Life Sciences discusses when to transition to a perfusion setup, advantages over static methods for adherent cultures, and other important details about popular perfusion applications.
Explore the potential of ribonucleoprotein (RNP) to deliver CRISPR materials more accurately, efficiently, and effectively, as well as the manufacturing challenges which require further attention. By Thomas Lynch, Ph.D. , VP Client Services, Aldevron
The FDA ’s approval of Amtagvi addresses an unmet need in melanoma patient care. Here, Genevieve M Boland, MD, PhD , from Mass General Cancer Center shares her insight on the approval.
Selecting a CDMO isn't just entering a transactional relationship. You are forming a long-term partnership that can impact the success of your current product and benefit the manufacturing of future products. Chathuranga De Silva Ph.D. shares some of the "intangible" decision factors, how they can shape your CDMO search, and what types of questions you can ask to assess them.
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“When you think about genetic therapies, they really are attacking it right at the core. The gene is defective. Fix the gene that's defective. It sounds that simple, and it is that simple, but it's not as simple as it sounds." -- Cat Lutz , VP, Rare Disease Translational Center, The Jackson Laboratory
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Stem cells are the backbone of many allogeneic, “off-the-shelf” therapies. Where they come from affects product development and supply chain logistics. What temperatures are ideal? How do you work with existing infrastructure?
Coeptis Therapeutics and Deverra Therapeutics ’ Dr. Colleen Delaney and Gamida Cell Ltd. ’s Nick Bayrakdarian join Cell & Gene Live’s Tyler Menichiello to discuss product development and supply chain logistic challenges affected by stem cell collection origins. Supported by Charter Medical and Bio-Techne .