BioPharm International, October 2023

Drug efficacy, reputation, and financial return are all on the line when it comes to fill/finish.

A survey was conducted to examine the adoption of machine learning and artificial intelligence in the bio/pharma manufacturing industry.

Biologics formulation comes with a unique set of challenges, which can be overcome through innovative strategies and good partnerships.

Using a systematic approach and achieving run-to-run consistency are essential.

The innovation of affinity ligands must take stability into consideration for present and future purification applications.

The steady rise in popularity of gene therapies and other biologics is the underlying reason for the growing importance of aseptic manufacturing processes in the biopharmaceutical industry.

Glycosylation analysis can provide a deep and nuanced understanding of immune cell phenotype and function.

The agency will be reorganizing field force and compliance functions.

If the Alliance for mRNA Medicines (AMM) tested the waters in June 2023 at the BIO Conference in Boston, then they engaged in a full-fledged triathlon in September, in the heat and humidity of Washington, DC.

It has been a long wait, but for Alzheimer’s at least, this is the beginning of renewed hope.

Maintaining compliance to compendial requirements should be straightforward, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates.