Under the commercial supply agreement, MilliporeSigma – the life science branch of Merck KGaA – will manufacture vectors for the Massachusetts, US-headquartered firm’s drug products, indicated to treat rare genetic diseases.
Merck told us the lentivrial vectors – which are used to deliver personalised gene therapies into immune cells – will be manufactured at its Carlsbad, California facility.
The firm recently expanded the gene therapy facility, which houses viral bulk manufacturing cleanrooms, fill/finish suites and viral vaccine and immunotherapy products.
Merck has expertise in the production of a wide variety of viral vectors used for gene therapy and viral vaccines, the spokesperson told us.
The firm “has a focus on quality in clinical and commercial supply as evidenced by our facility completing both a US Food and Drug Administration [FDA] Pre-License inspection and a European Medicines Agency [EMA] Marketing Authorization inspection,” he added.
Outsourcing relationships
A Merck spokesperson told us the firm has worked with bluebird bio “for some time on production of lentiviral vectors across all their programmes.”
In November last year, bluebird bio reaffirmed its commitment to its outsourcing partners, when it announced plans to buy a manufacturing facility in North Carolina but continue to work with contract manufacturers.
At the time, bluebird bio said the in-house lentiviral vector manufacturing facility would not disrupt multi-year contracts with firms including Brammer Bio, Novasep, and MilliporeSigma.