Bringing Gene Therapies to Market
Biopharma industry faces production challenges as gene therapies move from clinical to commercialization.
The approval of the first gene therapies and technology advances have spurred research and investment for new treatments and provided hope for patients. Researchers are now talking about “cures” versus “treatments,” says Eric Langer, managing partner, BioPlan Associates, in an interview with BioPharm International. Turning clinical processes into an operational process will prove challenging.
Understanding the Variability in Bioburden Test Results in Biomanufacturing
May 7th 2025This article explores the impact of test volume, microbial distribution, and dilution errors on bioburden testing variability. It presents statistical approaches to estimate percentage error and discusses strategies to optimize microbial enumeration techniques in biopharmaceutical quality control.
Drug Solutions Podcast: A Closer Look at mRNA in Oncology and Vaccines
April 30th 2024In this episode fo the Drug Solutions Podcast, etherna’s vice-president of Technology and Innovation, Stefaan De Koker, discusses the merits and challenges of using mRNA as the foundation for therapeutics in oncology as well as for vaccines.
Trump Directs FDA, EPA to Reduce Regulatory Barriers to Domestic Pharma Manufacturing
May 7th 2025The White House is instructing FDA to increase fees for and inspections of foreign drug manufacturing plants and reduce the time required to approve such sites that will be newly constructed in the US.
