BioPharm International, May 2023

New therapeutic opportunities are offering significant promise for the bio/pharma industry and patients.

The development of CAR-T therapies for solid tumor cancers presents a myriad of challenges.

It is crucial to examine the context in which single-use waste is viewed.

Optimization strategies that leverage advanced technologies are essential for maximizing yield and quality.

Avoiding missteps in data integrity is contingent on the development of a holistic data integrity approach.

Guidance for GMP manufacture of emerging therapies has evolved to accommodate innovation and the broader spectrum of products in development, but greater harmonization is still needed.

FDA is encouraging sponsors to conduct studies and file applications for full approval of products authorized by Emergency Use Authorizations.

The concept of quality culture and how to enforce it are being debated by regulators and industry, says Siegfried Schmitt, vice president, Technical at Parexel.

Preclinical studies specifically benefit from the “smart” drug development trend through deeper data access and analysis.

INTERPHEX was back in full swing with Keynote sessions highlighting cutting-edge technologies that are setting the stage for the bio/pharma industry’s future.

The engine that drives pharmaceuticals forward, its workforce, is now very low on fuel.