BioPharm International, August 2023

Broader industry shifts may lead outsourcing companies to prioritize integrated services.

Burgeoning CGT modalities bring promise and challenges.

Scale-up strategies for cell culture will require a deep understanding of overall bioprocess workflows.

Process automation technologies aid modernization and enable closed systems.

Sourcing of donor cells, access to fit-for-purpose reagents and manufacturing systems, and scalability are top issues.

Advanced analytical tools generate more data in today’s labs than ever before.

Context surrounding the Inflation Reduction Act is necessary for a comprehensive understanding of the global biopharma market.

More than a third of CMOs are struggling to keep skilled technical and production staff.

Manufacturer lawsuits prompt CMS to [slightly] modify pricing plan.

A proposed database includes key information about critical drugs, such as the country of origin and quantity, so supply chain weaknesses can be identified.

mRNA may be a modality whose chief advances are yet to come.

The more information shared, the smoother the approval process, says Susan J. Schniepp, distinguished fellow with Regulatory Compliance Associates.