Author Archives: Salome Philip

Advantages of flexible manufacturing in advanced therapies

With rapid market growth and over 1220 ongoing clinical trials, the need for flexible alternatives is higher than ever. To meet this demand, advanced therapeutic developers are utilizing flexible manufacturing and single-use technologies. This is an abridged version of an article first published as part of the BioProcess Insider ebook, entitled: Cell and Gene Therapies — A 2021 Industry Update. To download the full report, click here. Utilizing flexible systems like premanufactured cleanrooms can reduce costs, construction timelines, and time…

eBook: Cell and Gene Therapies —
A 2021 Industry Update

The US Food and Drug Administration (FDA) reports that as of June 2021, 22 advanced therapy products have received regulatory approval in the United States. The first such product gained regulatory approval in 2010. Since then, hundreds of cell and gene therapies have advanced to clinical evaluation, but few products have reached commercial stages — and those that have done so have been hindered by manufacturing problems. In this eBook, writers from the BioProcess Insider and Project Farma analyze trends…