Summary: The COVID-19 pandemic has roiled R&D plans, created new priorities overnight and generally forced a major shift in many global manufacturing operations. This is an unprecedented...

Summary: Get an insight into what it takes to move a pre-clinical drug candidate to a Phase 1 clinical trial. The presentations will provide guidance on non-clinical and regulatory considerations...

Summary: To minimize off-line manipulations with aseptically-closed bioreactor system, iCELLis® Nano tubing assemblies were designed to use on-line bio-welding technology for each step from...

Summary: k_La estimations were performed for the iCELLis® Nano and iCELLis® 500 bioreactors with equivalent packed-bed size and compaction (4m2 and 500m2).

Catalent offers a comprehensive suite of analytical services for traditional biologics and advanced therapies such as antibody-drug conjugates (ADCs), cell and gene therapies, and mRNA vaccines, including drug substance, drug product and intermediates, at our biologics analytical sites in the United States.

Summary: The FDA requires that host cell proteins (HCPs) be reduced to low levels because they can affect the safety and efficacy of a drug. Pharmaceutical Technology recently spoke with...

Summary: A relative potency assay was based upon inhibition of a mAb binding to a cell-surface expressed antigen on viable cells and assessed via flow cytometry.

Summary: Gene therapy is a rapidly growing area in healthcare but, now the promise has been shown, we must focus on improving the manufacturing process and reducing...

Summary: Bioassays and binding assays play a critical role in ensuring product quality, safety and efficacy.

Summary: Gene therapies have been exploding in popularity and lining up new programs looking to create a new standard of care models for a wide variety of diseases.