A General Chapter on mAbs will be published in USP-NF as biologics increase their role in healthcare.
The all-synthetic clarifying product line contains both an anion-exchange nonwoven media and a fine-particle, bioburden reduction membrane.
Meissner’s TepoFlex is a polyethylene biocontainer designed for secure handling and it is part of the One-Touch single-use systems portfolio.
Is there enough talent to go around?
The fast growth of the global biopharmaceutical market has prompted global pharmaceutical and biotechnology companies to increase their R&D investment in biologics.
The draft guidance contains policies for drugs that are processed with additional manufacturing steps such as remixing, dilution, and repackaging.
FDA has approved another indication for Eylea, a treatment for diabetic retinopathy in patients with diabetic macular edema.
The agency provides guidance on determining the need for environmental assessments for gene therapies, vectored vaccines, and viral and microbial products.
Guidance provides labeling standards and an implementation guide for electronic submission of lot distribution reports.