Merck Expands Commercial Manufacturing Capacity for Viral Vectors and Gene Therapy Products

DARMSTADT, Germany, April 21, 2020 /PRNewswire/ -- Leading technology company Merck announced today that it is building a second facility in Carlsbad, California, USA, to provide itsBioReliance® Viral and Gene Therapy Services. A new commercial facility valued at €100 million is expected to open next year.

Wu Boda, Member of the Executive Board of Merck KGaA and CEO of the Life Science BusinessUdit Batra) stated: “Viral vector manufacturing has transitioned from a niche industry to become the cornerstone of the future biopharmaceutical enterprise. Currently, only a few companies possess the scale and quality systems necessary for commercial manufacturing of viral vector products. Building on our success in helping customers commercialize gene therapies via viral vectors, our expansion will enable innovators to produce these treatments at a scale that ensures broader access for patients in need.”

Merck’s life sciences business facility in Carlsbad is capable of manufacturing gene therapy products for Merck’s global customers. Gene therapy involves delivering genetic payloads into patients’ cells to achieve therapeutic effects, such as correcting mutated genes or reprogramming immune cells to target and combat cancer. Diseases such as hemophilia and cancer are being studied using gene therapy technologies, which hold the potential to cure these conditions with a single-dose treatment. Viral vectors are often regarded as the most complex therapeutic agents currently being manufactured.Recent Biotech Forecasts: Global Market Analysis and Industry Projectionsstated that the global gene therapy market reached a value of $1 billion in 2018 and is projected to reach $10 billion by 2026.

Merck’s new 140,000-square-foot manufacturing facility will support the use of itsMobius® Disposable Device, enabling viral and gene therapy product manufacturing at a 1,000-liter scale. This facility is part of Merck’s Life Science business expansion of products and services for the viral and gene therapy market. With nearly 30 years of experience in cell and gene therapy, Merck’s Carlsbad, California site in the United States has been involved in the gene therapy field since 1997, a time when clinical trials in this area were just beginning. Over this period, Merck has manufactured viral vectors for two cell and gene therapy products.

This expansion underscores Merck’s continued investment in viral and gene therapies from clinical to commercial scale, marking the second major investment in its Carlsbad facility in recent years. The first major investment in 2016 nearly doubled the previous production capacity. The updated facility has expanded from 44,000 square feet to 65,000 square feet. Currently, the Carlsbad site features 16 modular viral batch manufacturing cleanroom suites equipped with single-use technologies, as well as two fill/finish rooms dedicated to gene therapies, viral vaccines, and immunotherapy products. With this expansion, Merck will add 11 suites, bringing the total to 27, which will be utilized for various steps in the manufacturing process.

In addition to providing contract development and manufacturing services for viral vectors, Merck also offers seamless manufacturing and testing services at its global pharmaceutical and biopharmaceutical testing facilities.

Merck recognizes that cell and gene therapies can bring about significant advancements in medicine. The company supports these therapies while taking ethical and legal standards into account; Merck has established an independent externalBioethics Advisory Panel. This group is able to provide guidance on a wide range of topics, including gene editing and the use of stem cells, all of which are relevant to its business activities. While taking into account scientific and societal issues, Merck has also established a clear operational positioning.

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