Author: Troy Fugate

In recent years, North Carolina has emerged as one of the most dynamic hubs of biopharmaceutical innovation and manufacturing in the U.S. With strong academic institutions, a growing workforce, favorable business climate, and rapidly expanding life sciences infrastructure, the “Research Triangle” region has become a magnet for biopharma investment, advanced therapies, and supply-chain development. Why…

The Oct 16, 2025 BPD Roundtable Dinner was nothing short of fantastic. From the first handshake during the networking hour to the last shared insight at the tables, the energy in the room was electric. Before we even sat down for the roundtable sessions, the networking buzz filled the air — people exchanging stories, ideas,…

GeminiBio has released an essential white paper on human serum use in cell therapy development and manufacturing. This guide delivers expert insight on regulatory, supply chain, and supplier considerations — helping cell therapy developers de-risk development and accelerate timelines. Choosing the right human serum goes far beyond simple sourcing. It means strategically navigating global regulations,…

After approximately four years of working on the guide, I’m happy to announce that our efforts and dedication have paid off.  The PDA has published the draft of BSR/PDA Standard 08-202x: Guidance for Manufacturers — Apheresis Collections for Cell & Gene Therapy Products, opening it for public review and comment. This is a pivotal moment…

Cell and gene therapies promise transformative outcomes but they also carry elevated risk and regulatory scrutiny. As the CGT sector matures, the FDA has sharpened its focus on manufacturing, control systems, and end-to-end quality culture. Below are five key observation areas CGT firms must take seriously: 1. Weak Quality Systems & CAPA Implementation What is…