BioPharm International, February 2023

A slew of late-stage clinical trials is expected to push new regenerative medicines onto the market in the next few years.

Improvement in viral vector yield has become integral to new cell and gene therapy product development.

In part 2 of this article, results from the testing of a next generation convecdiff membrane are discussed.

In vivo CAR-T gene therapies could overcome the challenges faced by autologous and allogeneic treatments.

Single-use systems hold key benefits for biomanufacturers, despite certain limitations.

Variability instills consistency in advanced therapy medicinal products.

In this paper, the authors lay out some commonly accepted HCP analytical methods, the challenges of HCP assay, and provide recommendations on what can easily be accomplished in-house and when it may be better to outsource.

A Congressional probe of FDA’s approval of Alzheimer’s treatment targets the agency’s interactions with drug manufacturers.

This new pioneering phase of mRNA is loaded with potential, but also obstacles and false dawns.

The restraint to not target solely the major disease groups has provided good proportion and balance for our industry.