BioPharm International, April 2024

The shift toward personalized medicines poses new challenges in cleanroom protocols.

Increases in efficiencies, flexibility, scalability, and sustainability are impacting adoption.

Innovation in this space depends on strategizing for GMP compliance and market access.

Despite a growing trend toward single-use bioreactors, stainless-steel retains its relevance for certain products.

A look at the newest innovations offers a deeper understanding of affinity ligands and their role in the future of downstream processing.

This article explores a grouping strategy for therapeutic peptides incorporating theoretical and experimental methodology and results to define a practical and scientifically justified cleaning procedure.

There are considerations companies may want to consider before seeking out a service provider.

Experts believe it is likely cancer cells are more common in the body than previously thought, but typically caught early and removed in the body’s cancer-immune cycle. When the system is in good working order (and protecting us), dead cancer cells release neoantigens.

Compliance can be greatly improved by concentrating on the basic elements of CAPA investigations, advises Kate Rice, global quality systems manager, Nelson Laboratories, and Susan J. Schniepp, distinguished fellow, Regulatory Compliance Associates.