Ensuring cGMP Compliance In Cell And Gene Therapy Manufacturing

Cell and gene therapies, promising cures for various diseases, are rapidly transitioning from academic research to commercial production. This white paper focuses on the essential equipment features required for Good Manufacturing Practice (GMP) compliance in cell and gene therapy manufacturing, specifically referencing Annex 1 of EU GMP, "Manufacture of Sterile Medicinal Products".

Readers will learn about the significant challenges in producing these complex, non-terminally sterilizable products, as well as the need for rigorous aseptic processes and specialized equipment design. It contrasts laboratory-grade equipment with GMP-compliant systems, detailing critical design considerations like seals, materials, and software validation to ensure product safety and regulatory adherence.

Access the full white paper to delve deeper into this topic.