MilliporeSigma, bluebird bio Partner for Viral Vector MfgBy
MilliporeSigma has signed a commercial supply agreement to manufacture viral vectors for bluebird bio, a Cambridge, Massachusetts-based clinical-stage gene therapy company, for its use in gene therapies.
Under the multi-year agreement, MilliporeSigma plans to manufacture lentiviral vectors for bluebird bio’s drug products developed to treat a variety of rare genetic diseases.
Gene therapy involves the delivery of genetic material into patient cells to produce a therapeutic effect such as correction of a mutated gene or retargeting of an immune cell to fight cancer. To create personalized therapy products, genes are delivered into immune cells using viral vectors.
MilliporeSigma says its Carlsbad, California manufacturing facility, which provides BioReliance viral and gene therapy manufacturing services, has been involved in the gene therapy area since 1997. In October 2017, this facility completed both a US Food & Drug Administration pre-license inspection and a European Medicines Agency marketing authorization inspection.
MilliporeSigma’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 vaccines, and immunotherapy products.