Burlington, Massachusetts, December 20, 2017 — MilliporeSigma today announced that it has signed a commercial supply agreement to manufacture viral vectors for bluebird bio, Inc., of Cambridge, Massachusetts, for its use in potentially transformative gene therapies.
“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.
About the Life Science Business of Merck KGaA, Darmstadt, Germany
The Life Science business of Merck KGaA, Darmstadt, Germany, which operates as MilliporeSigma in the U.S. and Canada, has 20,000 employees and 60 manufacturing sites worldwide, with a portfolio of more than 300,000 products enabling scientific discovery. Udit Batra is the global chief executive officer of MilliporeSigma.
Merck KGaA, Darmstadt, Germany completed its $17 billion acquisition of Sigma-Aldrich in November 2015, creating a leader in the $125 billion global life science industry.
Merck KGaA, Darmstadt, Germany is a leading company for innovative and top-quality high-tech products in healthcare, life science and performance materials. The company has five businesses – Biopharmaceuticals, Consumer Health, Allergopharma, Life Science and Performance Materials – and generated sales of €15.3 billion in 2017. Almost 53,000 employees work in 66 countries to improve the quality of life for patients, to foster the success of customers and to help meet global challenges.
Merck KGaA, Darmstadt, Germany is the world’s oldest pharmaceutical and chemical company – since 1668, the company has stood for innovation, business success and responsible entrepreneurship. Holding an approximately 70 percent interest, the founding family remains the majority owner of the company to this day. The company holds the global rights to the name and the trademark “Merck” internationally except for the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.