Sterling Pharma Solutions announced it has been granted Manufacturer’s Authorization for Investigational Medicinal Products from the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA). The license allows Sterling to manufacture antibody-drug conjugates (ADCs) for clinical use in its current Good Manufacturing Practices (cGMP) compliant manufacturing facility in Deeside, UK.
Sterling acquired the 6,500 square-meter site as part of its purchase of ADC Biotechnology in April 2021, and has since gone on to invest in expanding the facility to develop its scientific and analytical teams, install a new water for injection (WFI) plant, and establish bioconjugation and ADC manufacturing capabilities. The license allows for GMP bulk drug substance manufacture to support all phases of clinical studies, GMP release testing, and supporting stability studies. The site will work in parallel with Sterling’s facility in Germantown, Wisconsin, which provides services to develop and manufacture highly potent small molecules that make up part of an ADC drug molecule.
“The ADC facility in Deeside has over 12 years’ experience in technical development services for the industry. The granting of this license marks a major milestone for Sterling, with the company now able to integrate development and clinical manufacturing services across our network to support ADC innovators in bringing new therapies to the market,” said Kevin Cook, Chief Executive Officer at Sterling. “Our decision to expand the business in 2021 to include ADCs was strategic, to broaden our chemistry services offering to include specialized bioconjugation capabilities and has led to a number of partnerships in this area with drug developers. Our plan is to continue investment at Deeside as customer demand for these services increases to grow the business further.”
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