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.

Summary: Analytical testing for biologics is evolving rapidly as new protocols become available and companies seek to expedite current methodologies.

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...

Summary: Download the infographic to learn more about the latest cell-based bioassays and binding assays with an emphasis on their applications in the industry.

Summary: Patient centricity has always been at the heart of the pharmaceutical industry. With rising costs of drugs and healthcare, there has been...