Sterling Pharma Solutions granted MIA license for cGMP antibody-drug conjugate manufacturing at UK facility

By Rachel Arthur

- Last updated on GMT

The Deeside facility. Pic: Sterling Pharma Solutions
The Deeside facility. Pic: Sterling Pharma Solutions

Related tags Sterling Pharma Solutions ADC bioconjugates Antibody drug conjugates Wales Uk

CDMO Sterling Pharma Solutions has been granted a Manufacturer’s Authorisation for Investigational Medicinal Products from the UK’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’s origins are in small molecule API and manufacturing services, with facilities now in the UK, US and Ireland. In 2021, however, it acquired ADC Biotechnology – a UK-based bioconjugation development services business specialising in ADCs.  

Sterling acquired the 6,500 square-meter site in North Wales as part of this acquisition.

Since then, it has pumped £1m ($1.25m) into the site 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,” said Sterling’s CEO Kevin Cook.

“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.”

“Our decision to expand the business in 2021 to include ADCs was strategic, to broaden our chemistry services offering to include specialised 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.”

Sterling will host an open day at the Deeside facility on May 16, 2023.

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