"We look forward to collaborating with bluebird bio to bring to market breakthrough therapies to fight diseases for which there are limited or no options," said Udit Batra, CEO, MilliporeSigma. "With 30 years' experience in viral vector manufacturing, we remain committed to innovating with academia, hospitals and cell therapy manufacturers to accelerate access to personalized cell therapy for the patients who need it most."
Under the multi-year agreement, MilliporeSigma will manufacture lentiviral vectors for bluebird bio's drug products developed to treat a variety of rare genetic diseases. bluebird bio is a clinical-stage company that develops potentially transformative gene and cell therapies for severe genetic diseases and T cell-based immunotherapies for cancer.
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 like the ones manufactured by MilliporeSigma.
This contract builds upon MilliporeSigma's deep experience in producing viral vectors for gene therapy from clinical to commercial scale. The company has been involved in gene and cell therapy manufacturing tools and services for close to three decades.
MilliporeSigma's Carlsbad, California 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 U.S. 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 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.