With dozens of approvals expected in the coming years, the cell and gene therapy space has turned into a goldmine for contract manufacturers. But COVID-19 vaccines are also a potentially lucrative business for CDMOs, and one U.K. biotech has hired a new manufacturing head to help meet demand in both bustling markets.
The U.K.’s Touchlight has hired Karen Fallen, a former biologics manufacturing head at Lonza, as the CEO of Touchlight DNA Services, the company’s contract manufacturing business for plasmid DNA used in mRNA vaccines and cell and gene therapies.
Fallen joins Touchlight from her role as president of mammalian and microbial development and manufacturing at Lonza, where she guided 4,500 workers at 10 sites spread over three continents. Fallen was promoted to that role in April 2019 and has 30 years of experience in the industry, according to a release.
At Touchlight, Fallen will be tasked with expanding the DNA business’ manufacturing capacity and bringing on more customers to the fledgling unit. The company’s novel, synthetic “doggybone” DNA can be used as starting material for mRNA vaccines used against COVID-19, like those produced by Pfizer and Moderna, and in cell and gene therapy applications, Touchlight said.
Fallen’s leadership appointment comes as the COVID-19 vaccine race approaches the first pivotal late-stage data readouts and cell and gene therapies continue to garner huge financial investments from major drugmakers.
Pfizer and BioNTech will likely be the first to release phase 3 data on their COVID-19 shot, dubbed BNT162b2, this month as they seek to file for emergency approval by November.
Last week, the partners tapped German contract manufacturer Rentschler Biopharma to handle the downstream purification process for their vaccine. Rentschler’s work at its Laupheim, Germany facility will be to remove impurities from Pfizer and BioNTech’s manufactured mRNA, leaving the purified drug substance that is later added to medium and bottled, the CDMO said.
This process helps ensure the safety of the finished vaccine, according to Rentschler, and ensures the highest amount of viable mRNA is harvested.
Meanwhile, Big Pharma has made major investments in cell and gene therapy infrastructure in recent years to help streamline the notoriously expensive and time consuming manufacturing process.
In September, Pfizer and gene therapy maker Vivet Therapeutics partnered on a manufacturing deal for a Wilson’s disease gene therapy candidate that will be produced at Pfizer’s Chapel Hill, North Carolina plant. The pact is part of Pfizer’s “build-buy-partner” strategy, according to a spokesman, in which Pfizer builds gene therapy muscle by acquiring stakes in promising biotechs and then partners to bring their manufacturing processes in-house.
In the past few years, Pfizer has invested around $800 million to expand three facilities in North Carolina—including the Chapel Hill site—in what a spokesman called “arguably the largest investment” in the gene therapy field. The facilities total 300,000 square feet of manufacturing space.