Gene Therapy Manufacturing Make-Or-Buy Options Weighed
Once a gene therapy product begins to show promise in clinical trials, the next step is deciding how the product is to be manufactured. Options are to make the product in house, contract out the manufacturing, or to combine the two approaches. An industry representative discussed some of the advantages and disadvantages of each approach and what to look for in the site selection process if the company decides to build out.
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South Korea’s first approved gene therapy has been suspended from sale in the country, while recruitment in an ongoing US Phase III program has been temporarily halted, after findings that an active cell component may differ from the data submitted at the time of approval. While both manufacturer and regulator see no safety risk, results from an official Korean probe are due in mid-April.
The Swiss major's pharma chief tells Scrip that its gene therapy for SMA offers much more than Biogen's Spinraza for both patients and payers, noting that the company is ready with alternative payment models for the pricey treatment as soon as approvals for Zolgensma are granted.
The risk of inadvertently growing SARS-CoV-2 virus in cell and gene therapies and possibly infecting patients and workers should be assessed and mitigated, the agency advises.