Date: 2017-12-20
Type of information: Production agreement
Compound: viral vectors
Company: Bluebird bio (USA - MA) Merck KGaA (Germany)
Therapeutic area:
Type agreement: manufacturing - production
Action mechanism: gene therapy
Disease:
Details:
- • On December 20, 2017, Merck KGaA, announced that it has signed a commercial supply agreement to manufacture viral vectors for bluebird bio for its use in potentially transformative gene therapies. 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.
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 FDA Pre-License inspection and a European Medicines Agency (EMA) Marketing Authorization inspection.
Merck’s investment in the gene therapy space includes a recent expansion at Carlsbad to nearly double its former production capacity — from 44,000 square feet to 65,000 square feet. The site includes 16 modular viral bulk manufacturing cleanroom suites with single-use equipment and two fill/finish suites for gene therapy, viral vaccine and immunotherapy products.
The company also has viral and gene therapy manufacturing capacity and has cell-banking services in Glasgow, Scotland. It has cell-banking services in Rockville, Maryland as well, and offers BioReliance® biosafety testing globally for both clinical and commercial stage gene therapy products.
Financial terms:
Latest news:
Is general: Yes
