Burlington, Massachusetts, October 19, 2017 — MilliporeSigma today announced that its Carlsbad, California-based manufacturing facility for the production of BioReliance® viral and gene therapy products has completed both a U.S. Food & Drug Administration (FDA) Pre-License inspection and a European Medicines Agency (EMA) Marketing Authorization Application inspection.
“The successful FDA and EMA inspections of our Carlsbad manufacturing facility mark an important milestone for MilliporeSigma and our customers who are manufacturing exciting new treatments for cancer and many other diseases,” said Udit Batra, CEO, MilliporeSigma. “As one of the first CMOs in the industry to complete pre-licensure inspections for this class of therapies, this achievement underscores our commitment to bring our customers one step closer to commercialization of novel therapies.”
These inspections will enable one of MilliporeSigma’s key customers to launch its novel gene therapy in both the U.S. and in Europe, which is currently under review by both the FDA and EMA. The inspections were significant milestones in the approval process to obtain the licenses necessary to manufacture the gene therapy as a commercial product.
This key benchmark underscores MilliporeSigma’s continued investment in viral and gene therapies from clinical to commercial scale. MilliporeSigma has close to three decades of experience in gene therapy, and its Carlsbad site has been involved in the gene therapy area since 1997, near the time clinical trials for gene therapy began.
The Carlsbad facility provides contract development and manufacturing services that can contribute to a more efficient delivery of these lifesaving therapies to market. The business serves many leading developers of viral and gene therapy products globally.
The company’s Carlsbad facility underwent a major expansion in 2016, and is now nearly double its former production capacity. The upgraded facility grew from 44,000 square feet to 65,000 square feet and now 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.
MilliporeSigma also offers viral and gene therapy manufacturing capacity in Glasgow, Scotland, has cell-banking services in Rockville, Maryland, and offers BioReliance® biosafety testing globally for both clinical and commercial stage gene therapy products.
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. Diseases such as hemophilia and cancer are being investigated using this technique where a single dose may cure the disease.
MilliporeSigma recognizes the potential benefits of conducting properly defined research with genome editing because of the breakthrough therapeutic potential. Therefore, research with genome editing is allowed with careful consideration of ethical and legal standards. MilliporeSigma’s parent company has established a Bioethics Advisory Panel to provide guidance for research in which its businesses are involved, including research on or using genome editing.
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 some 22,000 employees and 59 manufacturing sites worldwide, with a portfolio of more than 300,000 products focused on scientific discovery, biomanufacturing and testing services.
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, a leading science and technology company, operates across healthcare, life science and performance materials. Around 57,000 employees work to make a positive difference to millions of people’s lives every day by creating more joyful and sustainable ways to live. From advancing gene-editing technologies and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices – the company is everywhere. In 2019, Merck KGaA, Darmstadt, Germany generated sales of €16.2 billion in 66 countries.
The company holds the global rights to the name and trademark “Merck” internationally. The only exceptions are the United States and Canada, where the business sectors of Merck KGaA, Darmstadt, Germany operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials. Since its founding 1668, scientific exploration and responsible entrepreneurship have been key to the company’s technological and scientific advances. To this day, the founding family remains the majority owner of the publicly listed company. For more information about Merck, KGaA, Darmstadt, Germany, visit www.emdgroup.com.