Merck enhances the manufacturing capabilities of commercial virus vectors and gene therapy products

, a leading technology company, today announced that it is building a second facility in Carlsbad, California, to provide its BioReliance (R) virus and gene therapy services. The new commercial facility, valued at 100 million euros, is expected to open next year.· The new facility, valued at 1®00 million euros, will more than double the existing production capacity of . Large-scale commercial production of virus vectors and gene therapy productsThe new commercial facility, valued at 100 million euros, is expected to open next year.

based on Merck's success in helping customers commercialize gene therapy with viral vectors, Merck's expansion will help innovators ensure that these treatments reach more patients in need and produce


vector manufacturing has transitioned from a niche industry to a cornerstone of the biopharmaceutical business of the future," said Udit Batra, executive board member of
Merck and chief executive of the life sciences business. Only a few companies now have the scale and quality systems to manufacture commercial virus vector products. Building on our success in helping our customers commercialize gene therapy with viral vectors, our expansion will help innovators ensure that these treatments reach more patients in need and are produced on a scale. The

's Life Sciences business unit facility in Carlsbad and is able to manufacture gene therapy products for Merck's global customers. Gene therapy involves sending gene loads into a patient's cells to produce therapeutic effects, such as correcting mutant genes or repositioning immune cells to fight cancer. Diseases such as haemophilia and cancer are being studied using gene therapy techniques, which make it possible for them to be cured in a single dose. Viral vectors are often referred to as the most complex therapeutic drugs currently manufactured. Recent Biotech Forecasts global market analysis and industry forecasts indicate that the global gene therapy market will reach $1 billion in 2018 and is expected to reach $10 billion by 2026.Merck's new 140,000-square-foot manufacturing facility will support the production of 1,000-liter viral and gene therapy products using its Mobius®s single-use facility. The facility is part of Merck Life Sciences' expanded products and services for the virus and gene therapy market. Merck has nearly 30 years of experience in cell and gene therapy, and its Base Carlsbad, California, has been involved in gene therapy since 1997, when clinical trials in gene therapy were just beginning. During this time, Merck manufactured viral vectors for two cell and gene therapy products.The expansion highlights Merck's continued investment in virus and gene therapy, from clinical to commercial scale, and is the second major investment in its Carlsbad facility in recent years. In 2016, the first major investment nearly doubled previous production capacity. The area of the updated facility has expanded from 44,000 square feet to 65,000 square feet. Today, the Carlsbad site features 16 modular virus bulk manufacturing cleanroom suites with disposable equipment, as well as 2 filling/processing rooms for gene therapy, viral vaccines and immunotherapy products. With this expansion, Merck will add 11 suites, bringing the total number of suites to 27, which will be used in many of the manufacturing steps.In addition to providing contract development and manufacturing services for virus vectors, Merck provides seamless manufacturing and testing services at its global pharmaceutical and biopharmaceutical testing bases.Merck recognizes that cell and gene therapy can lead to significant advances in medicine. The company supports these treatments taking into account ethical and legal standards; Merck has established an independent external bioethics advisory group. The team was able to provide guidance on a wide range of topics, including gene editing and stem cell use, all related to the business they were involved in. While taking into account scientific and social issues, Merck has also established a clear operational positioning.

aboutMerck is a leading technology company focused on healthcare, life sciences and high-performance materials. Around 57,000 employees worldwide work for Merck, which is committed to creating sustainable, enjoyable lifestyles that improve the daily lives of millions of people. Merck is everywhere, from advancing gene editing technology to discovering unique ways to treat the toughest diseases, to supporting smart devices. Merck's sales in 66 countries will be 16.2 billion euros in 2019.

scientific exploration and responsible management have become the key to Merck's technological progress. That's why Merck has evolved since it was founded in 1668. The founding family still holds a majority stake in the publicly traded company. Merck owns the name and brand worldwide, with the exception of the United States and Canada, where Merck operates healthcare businesses using EMD Serono, MilliporeSigma for life sciences, and EMD Performance Materials for high-performance materials.
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