With a surge of gene therapies coming through the clinic and a lack of CDMO capacity, having inhouse capabilities is driving investment and M&A activity.
As increasing numbers of gene therapies progress through the clinic and towards commercialization, it is no secret that demand for production capabilities is high.
The complexity and cost of making viral vector means is a problem, but a biopharma with its own capabilities holds a major advantage, it would appear, something Pfizer CSO Mikael Dolsten claimed at the Evercore ISI 2nd Annual HealthCONx Conference last week.
Image: iStock/syahrir maulana
The Big Biopharma firm has a site in Sanford, North Carolina, supporting its gene therapy pipeline. In August this year, the firm made a $500 million (€450 million) investment at the site to construct a manufacturing plant based on its recombinant adeno-associated virus (rAAV) vector platform for gene therapies and viral vaccines.
“We think that’s a very versatile flexible manufacturing platform,†Dolsten said, adding it will be used both for Pfizer’s own manufacturing needs and for its partners.
“It’s a competitive advantage, not just for our product, but for companies that wants to partner with Pfizer that may allow them to have an easier and more high-end dialogue with regulators across the globe about this new field and a new type of product.â€
His comments came the same week that Astellas entered an agreement to buy Audentes for $3 billion. The firm cited a viral vector plant in San Francisco, California as a major driver in the deal which, management said, allows Astellas to gain “a competitive advantage in the gene therapy business.â€
The other option for gene therapy developers is to use contract development and manufacturing organizations (CDMOs). However, the relatively little capacity available means gene therapy developers are having to reserve space years in advance and be subject to high-demand, low-supply price pressures.
But it is helping to shape the sector as third-parties look to acquisitions and expansions to take advantage of the demand. Thermo Fisher and Catalent have both bought their way into the market in the past year, buying Brammer Bio and Paragon, respectively.
Meanwhile, CDMOs like Fujifilm, Aldevron, and Viralgen have all invested in their capacity to help feed demand within the past few months.
Some CDMOs, have done both: Lonza, for example, acquired Dutch firm PharmaCell in 2017 and has built out its own capabilities in Pearland, Texas.