The growing complexity of therapeutic monoclonal antibodies (mAbs),
especially bispecific antibodies, presents significant manufacturing challenges such as
instability, low yields and aggregation. This article explores innovative solutions,
including detergent-based viral inactivation as an alternative to low pH treatment, high-
performance chromatography ligands and advanced formulation excipients.
Content on PharmTech.com this week ranged from fundamentals on the use of digital pathology in drug development, discussions on the use of AI in pharma, and regulatory actions impacting the industry.
This article discusses risk-based lifecycle governance, system implementation considerations, and the progression of batch record control from paper-based to fully electronic systems.
The FDA approves Lilly's once-weekly insulin efsitora for type 2 diabetes, raising Fc-fusion manufacturing, high-concentration pen, and capacity questions.
In this episode of Ask the Expert, Siegfried Schmitt, PhD, vice president, Technical at Parexel, and Susan J. Schniepp, distinguished fellow at Nelson Labs, discuss how companies should approach post-approval changes to their CMC regulatory filings.