Pharmaceutical News
Bringing cell/gene therapy products from lab to commercialization - quality control is the key
2021/07/31

The BIO Asia-Taiwan 2021 hosted a 5-day virtual conference and invited international experts to discuss issues concerning the combat of pandemic, advanced therapies, precision medicines, digital health and regional collaboration.   The industry drew particular attention to the clinical application of cancer gene therapy, future prospects and industrial collaboration.

Professor Dominic Wall of the Peter MacCallum Cancer Center, a world leading integrated cancer research, treatment and education center in Australia, mentioned a newly minted phrase: ‘The Product is the Process‘, which encapsulates the importance of the quality control during the manufacturing process of cell/gene therapy products.   It also highlights the difficulties in bringing a product from labs to commercial production lines as manufacturers have to make huge investment so as to meet the strict GMP quality requirements.

Dr. Didier Dargent of Novartis expressed that quality control is the most important aspect of developing a cell/gene therapy product.  Therefore, it is crucial for the developers to collaborate with medical centers. Through vigorous training and certification, medical centers can then build up the facilities, staff and technique required for the provision of CAR-T treatments.

CAR-T treatment requires cross-disciplinary collaboration.  As a result, it has changed the relationship between manufacturers and healthcare providers.  Dr. Dargent expressed that Novartis has a mission of “discovering new ways to improve and extend people’s lives”.   The clinical application of cell/gene therapies is still at the initial stage.  However, it is obvious that a well-established industrial chain and the cross-disciplinary collaboration are crucial to the development of cell/gene therapy products.   How to successfully transfer the academic research results to commercilization is the biggest challenge. 

Dr. Dargent mentioned that it is foreseeable that the treatment quality will continue improving alongside with the experiences gained by the industry.  At the same time, the development of cell/gene therapy products will push the integration of all industries involved and prompt the creation of a highly sophisticated industry environment for strong global competitiveness.

【2021-07-29 / Economic Daily】