“We are seeing a shift towards localisation of supply chains from innovation to manufacturing and production’

For developers of cell and gene therapies (CGT), translating a drug from a biologic concept to a scalable and manufacturable F(CGT), translating a drug from a biological concept to a scalable and manufacturable treatment can be the largest challenge in achieving commercial success.

- Hithaishi C Bhaskar

This is especially difficult in the CGT field, because there is a limited number of qualified personnel with both biological and process engineering know-how. Other challenges are evolving regulatory constraints and aggressive timelines from investors. Even for experienced teams, it can be tricky to balance the efforts of reaching the first clinical trial using a manual, open method with building a more commercially suitable process. In an interaction with BioSpectrum Asia Francis Van Parys, Vice President (Commercial) APAC, Cytiva shared his views on how can biopharma companies optimise their manufacturing process to capitalise on the rapidly growing CGT market and company’s growth plans for the APAC hub in FY 22-23.

How can biopharma companies in Asia optimise their current manufacturing process for precision medicine, particularly in Cell and Gene Therapy (CGT), to capitalise on the rapidly growing market?

Advancement of technology has certainly influenced the way medicines are being developed. The power of genomics, big data, and new scientific discoveries are driving progress in personalised medicine. This leads to manufacturing wider varieties of monoclonal antibodies, for instance, in smaller quantities; in the case of cell and gene therapy, individualised treatment tailored for the individual patient. Despite the increased number of precision medicine trials, the development of highly unique medicines however is still fraught with high manufacturing costs, complex logistics and supply chains, and high risks of failure.