Merck announced the expansion of its high-potent active pharmaceutical ingredient (HPAPI) and antibody-drug conjugate (ADC) production capabilities and capacity at its facility in Madison, Wisconsin, US, in September 2020.
With an estimated investment of $69m (€59m), the expansion will facilitate large-scale production of increasingly potent compounds for potential cancer treatment. The Madison facility expansion will create approximately 50 full-time jobs beginning in 2021, expected for completion by mid-2022.
Merck will add a new 6,500m² (70,000ft²) commercial building dedicated to the HPAPI manufacturing facilities in its established Madison campus.
The new building will feature one of the largest single-digit nanogram containment production facilities for the manufacturing of HPAPIs. It will handle nanogram-single-digit occupational exposure limit materials, allowing for a continuous flow of ADCs production.
Madison facility, the first commercial facility in the US dedicated to the development of ADC, handles highly active materials.
The addition of the new building will expand the company’s ADC manufacturing capabilities together with the existing campus in St Louis, Missouri, US, that specialises in ADC bio-conjugation, APIs, excipient and adjuvants manufacturing.
ADCs are a new group of medications designed as a targeted therapy for cancer treatment, developed by linking a cytotoxic anticancer drug payload to a highly specific antibody via a biodegradable linker.
The biochemical reaction between the antibody and targeting antigen absorbs the ADC into the cancer cells where the cytotoxic drug is released to destroy the cancer cells.
The production of ADC is complex and requires a strict containment infrastructure. Its structural exceptionality involves experience in various technologies for small and large molecules, as well as analytical capability.
Just nine ADCs in the world currently hold approval, with the ADC market projected to hit $15bn by 2030.
Merck’s existing manufacturing facility in Madison handles HPAPIs, APIs, linkers, cytotoxic materials, payloads and secondary metabolites.
Madison facility has a wide range of manufacturing spaces and machinery. It has the requisite versatility for the multi-step synthesis of complex and HPAPIs. It can support the development and production of complex small molecules from pre-clinical to commercial scale.
Pilot and production-scale facilities and equipment are certified for handling Safebridge® Cat IV materials and can support HPAPI manufacturing. Most of the kilo labs are also Safebridge® Cat IV qualified.
Some of the safety features of the facility include differential room pressure designed for containment, airlocks, HEPA filtered single-pass air and contaminants capturing with safe-change filters.
The company has two sites in Madison for process development with process scale-up laboratories.
The Madison facility’s experience in linker and payload technology manufacturing combines with the St Louis’ clinical and commercial ADC facilities to provide comprehensive supply chain solutions.
The solutions include the company’s end-to-end BioReliance® capabilities for process development and cGMP monoclonal antibodies manufacturing for clinical supplies.
Merck is a global pharmaceutical company headquartered in the US. The company delivers vast expertise in both clinical and commercial manufacturing. Furthermore, it has more than 35 years of experience in the production and manufacture of small molecules, biologics, and ADC technologies.
The company holds global rights to the Merck brand except in the US, as well as Canada, where its business divisions operate as EMD Serono in healthcare, MilliporeSigma in life science and EMD Performance Materials.