Personalized meds and cell and gene therapies are forcing biopharma to rethink manufacturing, supply chains and logistics says the head of Novasep’s new biopharma unit. Patient-specific therapies, particularly cell and gene therapies, have the potential to treat disease more effectively than ever before. But from a manufacturing perspective personalized medicines, including bespoke cell and gene therapies, are a “paradigm change” for which established production strategies will not work, notes Cédric Volanti.

“The major impacts of personalized medicine will probably be on the supply chain, planning and logistic to deliver the product on time to the patient,” he explains. “The business model associated with large capacity plant for commercial drug manufacturing will need to evolve into and agile and reactive business model.”

The comments come weeks after Novasep launched its Biopharma Solutions Business, which is designed to improve the firm’s ability to cater for changing industry contract manufacturing needs. According to Volanti, “We wanted to give more visibility to this offering to our customer and the market stakeholders in general.”

The new Business Unit will primarily focus on production of viral vectors for the cell and gene therapy market, capacity for which has been limited for the past few years. Another of Novasep’s aims is to facilitate smoother transition of projects from one stage of development to the next.

“It will offer a complete and integrated solution for our customers ranging from early-stage process development up to Fill-and-Finish for commercial phases,” he says. “Customers want to have a clear understanding of your services and capabilities. In doing this we believe we have accomplished this. The combination of Senrise-IV and Senefill [Novasep’s newly established facilities] will increase our one-stop-shop capabilities. The Business Unit will be directly reporting to the Executive Management giving easier and more flexibility to manage its growth and investment.”

Technology needs

In addition to rethinking manufacturing facilities, personalized medicines developers also need better technologies, Volanti says. He cites inefficient post-bioreactor capture and harvesting operations as an ongoing difficulty, explaining “Downstream process and especially purification are probably where technology improvement would be the most valuable.”

Bioprocess 4.0 has the potential to solve some of these challenges. However, such technologies need to be used appropriately, continues Volanti, who cautions against “automatically” adopting the latest systems just because they are new, all puns intended.

“Automation and integrated bioprocessing systems are indeed of interest for biopharma companies,” he points out. “But in the particular context of cell and gene therapy, full automation is not an option as the manufacturing process still required manuals steps and the involvement of operators.”

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