Eurofins BioPharma Product Testing (EBPT) in the US is a leading entity in the analytical testing of Cell and Gene Therapy, with its involvement dating back to 2010 at the Eurofins BPT Lancaster, PA location. Over the past decade, EBPT has developed a comprehensive business strategy catering to the analytical industry's needs, covering Raw Materials, Cell Banks, Plasmids, Viral Vectors, Genetically Modified Cells, CAR-T drug products, and iPSCs. The company has actively supported the growth of Cell and Gene Therapy through strategic investments, including the adoption of innovative technologies like droplet digital PCR, Analytical Ultracentrifugation , and Transmission Electron Microscope testing. These investments also involve dedicated facilities at various locations across the US.
This week, the FDA opened applications for its Expedited IND Pilot, quality experts presented at the PDA/FDA Joint Regulatory Conference, and Hovione expanded its spray drying capacity.
Andrea K. Kerrigan, FDA, outlines how validation, data integrity, and QRM determine whether digital tools and AI strengthen or undermine CGMP compliance.
PharmTech spoke with Tara Dougal, event director for pharma at Informa Markets, about trends impacting the pharmaceutical industry and how CPHI Milan is addressing these areas this year.
The recently opened NJ spray drying facility doubles capacity for amorphous solid dispersions, addressing solubility limits in roughly 70% of small-molecule pipelines.