Services companies invest in antibody-drug conjugates

As pharmaceutical companies embrace antibody-drug conjugates (ADCs) as a way to treat cancer, drug services providers are investing in capacity to meet the companies’ manufacturing needs.

MilliporeSigma, the North American drug services arm of Merck KGaA, says it will invest $76 million to manufacture ADCs for cancer therapies. The new funding will triple the company’s ADC capacity in Saint Louis to make early- and commercial-stage drugs.

And Sterling Pharma Solutions, a UK-based contract development and manufacturing organization (CDMO), says it will spend $12 million to expand ADC capacity in Deeside, Wales. The investment will go toward a 214 m²suite with 500 L reactors used to carry out ADC bioconjugation, the company says. It adds the expansion will more than double the site’s existing capacity.

Earlier this year, Veranova, a US drug services company, said it would spend $30 million to expand ADC manufacturing at its facility in Devens, Massachusetts.

ADCs are compounds in which a small-molecule anticancer drug is attached to a monoclonal antibody via a linker. The antibody acts as a carrier that selectively delivers the cytotoxic payload within the tumor mass. The US Food and Drug Administration has approved over 12 ADCs as treatments for various forms of cancer, and over 266 ADC drug candidates are being tested in clinical trials worldwide, according to Hansen Wade’s Beacon platform, which maintains data about clinical trials.

Kishore Hotha, founder of Dr. Hotha’s Life Sciences and a former Veranova executive, says the growing number of approvals and clinical trials is creating a need for third-party services. CDMOs are scaling up production to meet that demand.

“In the ADC space, CDMOs want to be a one-stop shop” for biotechnology companies that lack their own capacity, Hotha says. “These companies work with CDMOs from the initial steps. The CDMOs often help companies identify the suitable monoclonal antibodies, cytotoxic drug, and linkers needed to make the drug.”

The process takes over 7 months and requires a high level of expertise to test and validate compounds before they are tested on humans, he adds.