BRIEF—Merck signs viral vector manufacturing deal with US biotech

German science and technology major Merck KGaA has signed a commercial supply agreement to manufacture viral vectors for US clinical-stage biotech firm bluebird bio (Nasdaq: BLUE) for its use in potentially transformative gene therapies.

Just last month, bluebird bio bought a new manufacturing facility in North Carolina, USA, to support clinical development of lentiviral vector for its gene and cell therapies. It also entered into a strategic manufacturing agreement with Lonza providing for the future commercial production of bluebird bio’s Lenti-D and LentiGlobin drug products last year, as well as with German company apcethSave Biopharma.

Under the multi-year agreement, the Life Science business sector of Merck will manufacture lentiviral vectors for bluebird bio’s drug products developed to treat a variety of rare genetic diseases. No financial terms of the collaboration were disclosed.

Merck’s Carlsbad, California, USA-based manufacturing facility, which provides BioReliance viral and gene therapy manufacturing services, has been involved in the gene therapy area since 1997, near the time clinical trials for gene therapy began.

In October 2017, this facility completed both a US Food and Drug Administration Pre-License inspection and a European Medicines Agency Marketing Authorization inspection.

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