Biopharma CDMOs need to rethink production according to Resilience CEO Rahul Singhvi, who says industry must learn to make a new generation of complex products.
Advances in biological science in recent years are helping the biopharmaceutical industry to start unlocking the potential of cell and gene therapies.
For example, in the past few months the US FDA has approved two cell based cancer meds â€“ Abecma (idecabtagene vicleucel) and Breyanzi (lisocabtagene maraleucel) â€“ further underlining the cell therapy sectorâ€™s potential.
The difficulty now is making these products in a cost efficient, robust manner according to Rahul Singhvi, CEO of Canada-based CDMO Resiliance, who told BPI West attendees Biopharma must embrace innovation.
â€śAs we looked at the future of medicine, the newer medicines that are coming through important innovations that were going on in biology required us to produce very different type of products,â€ť he said, citing cell therapies or those that use vectors to deliver genomic payloads as examples.
â€śAll of these type of medicines require very different type of experience expertise and capabilities for producing the product and what we had learned over the past several decades was probably not enough.â€ť
Resilianceâ€™s approach has been to invest in capacity, manufacturing innovation and a team with the know-how needed to make innovative products.
â€śSo the main purpose of forming this company was to really, for the first time, make strategic investments in manufacturing science and technology, which would enable the processes to produce these complex medicines bring and bring them up to standard to the rate at which biology was creating these new type of modalities.
â€śThis investment would be something that would completely change the way we make these medicines from the status quo. And really increase the opportunity for more people to benefit from these type of medicines, through better access and also better affordability.â€ť
The CDMO has established five â€śfranchisesâ€ť that specialize in the production of one type of advanced therapy. Quality oversight is provided by a centralized unit.
Since launch last year, the firm has bought CDMO assets from Therapure, added a Boston plant from Sanofi-Genzyme, subleased a plant from Orchard Therapeutics, and â€“ most recently â€“ acquired CDMO Ology Bioservices.
Innovation is also needed to cater for growing customer demand for real-time updates according to Singhvi, who cited Resilienceâ€™s planned digital infrastructure as an example.
â€śThe digital infrastructure that we are putting in place is largely to ensure that we have high level of customer transparency and this is a feedback that we’ve received from customers that have told us that they need real time knowledge of what’s happening in the facilities they also would like to have access to data in a real time basis.â€ť
The systems also allows manufacturing data to be inserted into regulatory documents in preparation for submissions rapidly after the product is made.