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Advanced therapy medicinal products (ATMPs) must comply with Good Manufacturing Practice (GMP) production standards. Whilst industry requirements for ATMP manufacture have clearly been articulated by the Advanced Therapies Manufacturing Taskforce, academic requirements have not been represented despite the key role that the academic pipeline plays in driving the advanced therapies commercial ecosystem. Commissioned by the London Academic Health Science Centres/ Network executive group and working in partnership with KCL, Imperial and MedCity, the CGRM TIN assessed the requirements for GMP production of cell, gene and regenerative therapies from the pan-London academic base 2016-2021.
Our analysis shows that the pan-London academic pipeline is extensive and will require significant increases in GMP capacity to support projected increases for viral (adeno-associated virus, lentivirus), cellular and tissue-engineered products by 2021. The analysis is being used to support a national dialogue around innovative capacity solutions for the academic GMP pipeline.