The 17,000 sq ft (1579.3 sq. m) facility is scheduled to begin operations in May 2023.
Lonza’s EDS capabilities are focused on assessing, de-risking, and optimizing biotherapeutic drug candidates to maximize their chances of success. Helping customers identify and mitigate potential issues early in development and before clinical trials reduces failure risks in the drug candidate journey, and potentially accelerates speed to clinic, said the contract development and manufacturing organizaiton (CDMO).
The Swiss company's EDS unit in Cambridge in the UK is designed to help customers to improve the safety and manufacturability of biotherapeutic candidates. Services are provided via a suite of in silico, early non-GMP protein expression and in vitro immunogenicity services. The new facility in the US will offer the same capabilities, namely early non-GMP expression and in vitro immunosafety assessment services, said the organization.
Located close to the Boston biotech community, Lonza said the US entity will primarily serving preclinical stage small- to mid-sized biotech companies in the development of biologic drug candidates.
“On average, only one in every thousand molecules succeeds beyond Phase 1 trials. In this environment, early development services are essential in mitigating risks, reducing attrition, and improving the quality and safety of biologic treatments,” commented Jean-Christophe Hyvert, president, biologics, Lonza.
Early assessment of immunogenicity, developability and manufacturability of novel drug candidates significantly increases the chances of success, added Yvette Stallwood, head of EDS at the CDMO.
Separately, last month Lonza announced that Asher Biotherapeutics, a biotechnology company developing precisely targeted immunotherapies for cancer, chronic viral infections, and autoimmune disorders, has expanded its manufacturing agreement with the contract manufacturer to include production of AB248.
AB248, Asher Bio’s lead cis-targeted immunotherapy, is a fusion protein that selectively activates the IL-2 pathway in CD8+ T cells, which are key drivers of anti-tumor efficacy.
By maximizing the activity of IL-2 on CD8+ T cells, while limiting its activity on immunosuppressive regulatory T cells (Tregs) and NK cells, AB248 is designed to deliver improved on-target pharmacology, antitumor immunity, and enhanced tolerability. Asher Bio is developing AB248 for the treatment of multiple solid tumors, as both a monotherapy and in combination with checkpoint inhibitors.
Under the terms of the agreement, Lonza will manufacture AB248 at its site in Visp in Switzerland, providing drug substance manufacturing for phase 2 clinical supply. Since fusion proteins are manufactured by joining two or more genes encoding separate proteins, their manufacturing requires specific experience with solving protein folding and stability limitations.
Asher Bio said it will leverage the CDMO's expertise in manufacturing complex proteins, as well as the company’s extensive regulatory competence, tech transfer expertise and manufacturing network. The parties said they aim to commence manufacturing in Q2 2023.