Advanced Medicine: Replicating the mAb Success Story
What lessons has the industry learned from the manufacture of monoclonal antibodies? And how can these help us face the challenges presented by viral vector production for cell and gene therapies?
Stephanie Sutton | | Interview
The rise of monoclonal antibodies (and other important biopharmaceuticals) has taught the industry much in terms of how to successfully manipulate and manufacture living cells to achieve the desired yields and properties. But the next stage of evolution for drug manufacturers is far more complicated and tends to require the production of viral vectors; relatively few cell and gene therapies have been commercialized so far – and prices are high, reflecting the increased development and manufacturing challenges. There is a long way to go before the industry can say it has truly optimized the processes for bringing these advanced therapies to market. Clive Glover, Director, Cell and Gene Therapy, and Rene Gantier, Director Biotech Process Research & Development, both from Pall, review the progress so far and assess how manufacturing can be improved for viral vectors.
What cell and gene therapy milestones have we passed in recent years?
Clive Glover: Well, there have been exciting approvals and some amazing results coming from the clinic. One key milestone that stands out to me in particular, is the deal signed between Novartis and the University of Pennsylvania in 2013 because it really kicked off the CAR-T field and put advanced medicine in the spotlight for big pharma and investors. And then we saw the beginnings of companies like Kite Pharma, which was purchased by Gilead, and Juno Therapeutics, later purchased by Celgene. When it comes to the gene therapy side, there are many small gene therapy companies that have been struggling along for years, but 2013 saw investors really stand up and take notice of these, too. Today, there is a phenomenal amount of investment going into both cell therapy manufacturing and gene therapy manufacturing. According to estimates, around $22 billion in capital funding was committed to the industry in 2018, which is 30 percent increase on the funding received in 2017.
Rene Gantier: This is a big moment for the sector, especially for gene therapy, which has been waiting a long time. The money pouring into the field means that companies can start to tackle the challenges associated with industrialization and figure out how we safely bring these therapies to as many patients as possible.
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