Aseptic Risks, CDMO Selection, and CRISPR RNPs

Aseptic Risks, CDMO Selection, and CRISPR RNPs

TRENDING CONTENT - Catch Up

#1 FDA's CBER Issues Final Guidance For CAR T Cell Products

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.

#2 A Novel Approach To Managing Risks In Aseptic Processing Of Cell & Gene Therapies

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.

#3 Is A Perfusion Cell Culture System Right For Your Adherent Cultures?

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.

#4 CRISPR RNPs And The Future Of Cell And Gene Therapy

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

#5 Mass General Cancer Center's Dr. Genevieve Boland on Amtagvi Approval

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.

#6 Choosing A CDMO: Top 10 Intangibles Biotech Firms Should Consider

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.


CELL & GENE: THE PODCAST - Listen Here

“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

CELL & GENE LIVE! - Register Now

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 .

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