Global contract development and manufacturing organization (CDMO), Sterling Pharma Solutions, has announced the acquisition of ADC Biotechnology, a UK-based bioconjugation development services business specializing in antibody-drug conjugates (ADCs).
This follows an announcement by Sterling in December of a strategic investment into the ADC Bio business, with a view to acquisition in 2021.
The Deeside, Wales, UK facility will rebrand to become part of the Sterling Pharma Solutions international network. Together the teams will establish a center of excellence for bioconjugation and ADC development and manufacturing services, which combine Sterling’s 50 years of experience in cGMP manufacturing, quality processes, and compliance, with the expertise of the ADC Bio team and the state of the art facilities available at Deeside.
A multi-million-pound investment will support the growth of the company’s ADC capabilities, which will include growing and developing the existing bioconjugation technical services team and expanding the analytical services team, particularly in the cGMP area. As well as this, the team will develop and establish cGMP bioconjugation/ADC manufacturing at Deeside in 2022.
“We are delighted to confirm the acquisition of the ADC Bio business, this investment provides us with the opportunity to offer a wider portfolio of services to our customers in the fast-growing ADC and bioconjugation market, as well as providing additional services to existing ADC Bio customers,” Kevin Cook, Chief Executive Officer at Sterling Pharma Solutions noted.
“Integrating our HPAPI capabilities with the expertise already found at Deeside means that we will also be able to offer the development and manufacture of toxin linkers. This is an exciting time for both businesses as we embark on a period of growth and diversification to ensure we always stay ahead of the next innovation. I’d like to welcome all ADC Bio employees to the Sterling family,” Cook added.
“This is fantastic news for our employees and our customers; targeted investment in both people and processes will allow the team to continue supporting important advances in drug development with additional services, and importantly with the additional support and experience from the Sterling team,” Alan Raymond, Executive Chairman of ADC Bio, added.
Following the news of the acquisition, one of Sterling Pharma Solutions’ customers, ADC Therapeutics, confirmed that it had received approval from the U.S. Food and Drug Administration for loncastuximab tesirine-lpyl, (Zynlonta™, previously known as ADCT-402), an antibody-drug conjugate that the company’s Deeside facility contributed in developing.
Loncastuximab tesirine has been granted accelerated approval by the FDA for use in adult patients with relapsed or refractory B-cell lymphoma (DLBCL), including DLBCL not otherwise specified (NOS), DLBCL arising from low-grade lymphoma, and also high-grade B-cell lymphoma, and is now commercially available in the United States. The drug addresses a significant need for treatment options for patients with DLBCL, the most common type of non-Hodgkin lymphoma in the US.
Sterling’s dedicated bioconjugation team, based at its Deeside, Wales facility in the UK, previously known as ADC Bio, has worked in close collaboration with ADC Therapeutics for almost a decade. The teams have worked on the loncastuximab tesirine project since 2014, when loncastuximab tesirine was nominated as the lead candidate. Sterling established a scalable process and supporting analytics, then transferred these into a CMO for clinical manufacturing and performed process characterization studies in support of the Biological License Application.
“I am delighted by this success for ADC Therapeutics. Our bioconjugation team has been working with the team at ADC Therapeutics for so many years, and it has been a real pleasure to play a part in establishing the pyrrolobenzodiazepine (PBD) ADC payload platform as another validated weapon in the fight against cancer,” said Colin McKee, Head of Technical Services at Sterling.
“It is incredibly rewarding to work with a team that’s values align so well with our own, and our work over the years has seen us develop into a truly collaborative team which has allowed us to share in this recent success,” he concluded.
Featured image: ADC Biotechnology in Deeside, North-Wales, UK. With the availability of a new cleanroom, the company continues its focus on antibody-drug conjugates (ADCs) and developing new process technologies to speed up, simplify and significantly lower the production costs of the latest generation of anti-cancer blockbuster drugs. Photo courtesy: © 2017 – 2021 Sterling’s/ADC Biotechnology. Used with permission.