The Future of Biopharma: What Does the Industry Want & Need?
What Does the Industry Want and Need?
Eric S. Langer, President and Managing Partner, BioPlan Associates, Inc., shared these most-needed cell and gene therapy manufacturing improvement, systems, platforms, and infrastructure from his company’s research1 at the 2019 ISPE Biopharmaceutical Manufacturing Conference (as indicated by the percentages of survey respondents who chose these options):
FDA Forges Ahead to Support Cell and Gene Therapy
The FDA is working to streamline the review and safety reporting requirements for gene therapy protocols.2
NIH’s Recombinant DNA Advisory Committee (RAC) will transition to become the Novel and Exceptional Technology and Research Advisory Committee (NExTRAC), focusing on evaluating new biotechnologies and emerging applications.
ISPE has published a new Good Practice Guide: Critical Utilities GMP Compliance—How to Be Compliant and Ready to Prove It. Written and reviewed by a team of experts from around the world, the guide is the first of its kind in the industry. Team co-leads Nik Krpan and Rod Freeman talked with...
In March 2020, the ISPE Eurasian Economic Union (EAEU) Affiliate was officially established. This event was a significant step along the journey to integrate members from Eurasian Economic Union nations into the international pharmaceutical community, as well as another sign of progress in the...