03.26.24 -- Beyond (And Better Than) mRNA: T Cell Vaccines

The U.S. FDA issued 180 warning letters to drug and biologics manufacturers in fiscal year 2023 (FY23) and 94 of them were based on an on-site inspection of the company. This article provides an analysis of trends and observations from the inspection-based letters, as well as additional insight on the agency’s approach to enforcement.

When it comes to transporting highly sensitive and valuable materials, learn how teams can ensure that unique storage and distribution requirements are met.

The industry dynamic is shifting from a majority of CRAs who boast some medical background to individuals who have very little, if any, medical training.

For any biotherapeutic in development today, a critical element in achieving commercialization is reducing manufacturing risk.

Mesenchymal stem cell (MSC) development is accompanied by several challenges related to adequate characterization, regulatory adherence, and balancing upstream and downstream development considerations.

Validated processing methods and storage conditions are the first steps towards providing a safe and effective product for transplant. Review a retrospective analysis of a final verification process.

Learn how our expertise in high-yield suspension cell lines, robust lentiviral vector production, and extensive quality control measures can expedite your innovative lentiviral vector programs.

With gene therapy advancing at a record pace, Aldevron recognizes the enormous promise your work can bring to therapeutics. We are proud to deliver a superior, modern plasmid technology to your therapeutic endeavors.

Learn more about BioCentriq’s manufacturing, science, and technology (MS&T) team, which uses a quality-by-design framework to serve as a hands-on liaison between partners and BioCentriq’s own process development and manufacturing teams.