BioPharm International, February 2024

In the ATMP space, CGTs are hitting their stride with unprecedented approvals in the past year alone.

The authors present a methodology to assess the contribution of individual filters to overall capacity of the direct filtration train, and elucidate how capacity is affected by characteristics of the cell culture broth and process parameters, including for enhanced upstream processes such as those incorporating high cell density perfusion.

Despite slow growth over recent years, the CAR-T cell therapy space is expected to see considerable advancements in the near future.

Buffers, stabilizers, and cryoprotectants play major roles in cell therapy formulations.

The milestone approval of a gene-edited therapeutic paves the way for gene-editing technologies.

SUS aids biopharma manufacturers to overcome the rigidity of more traditional stainless-steel technologies.

Developing freeze-drying processes requires patience and deep product and process understanding.

Strategizing a PK/PD study approach in early phase development facilitates a successful clinical progression.

Given its positioning at each new year’s commencement, the J.P. Morgan Healthcare conference helps establish the tone with which the pharmaceutical industry is viewed.

Validating computerized systems is required to demonstrate adherence to data integrity, says Susan J. Schniepp, distinguished fellow at Nelson Laboratories, LLC.