Recent advances in personalised regenerative medicine have been significant. However, further developments are needed to support market and regulatory demands, particularly the development of manufacturing processes to support large scale batches of high-quality viral vectors.
Here, Pall Corporation describes the development of a robust integrated adenoviral manufacturing platform using adherent cells. A step-by-step scalable approach was implemented starting from laboratory scale to develop a fully integrated and reproducible process.
Such a well-controlled operational manufacturing process allowed the production of large amounts of high-quality viral vector in compliance with good manufacturing practice (GMP) requirements suitable for the clinical trials.