Antibody-drug conjugates (ADCs) – composed of an antibody linked to an active cytotoxic payload – have traditionally been used for oncology indications, to target and kill cancer cells.
While UK-headquartered ADC Bio said indications are now expanding to include antimicrobial and anti-inflammatory targets, industry is still “some way off” establishing a fully optimised manufacturing process for the ADC supply chain.
“As a product class, it’s still in its infancy and there are a number of process improvements that can be made to the production of cytotoxics, including the linkers that bind them to antibodies,” said ADC Bio CEO Charlie Johnson.
To speed up these processes, innovators need to focus on development at an R&D level, with contract development and manufacturing organisations (CDMOs) “seizing” industry’s initiative to drive innovation, he added.
“In particular, biotech customers may hold the key to increased adoption – as larger pharma companies might be too risk adverse – embracing innovation that delivers more efficient systems for producing their drug candidates in clinical development.”
One CDMO for supply chain efficiency?
Employing one CDMO to handle multiple processes – for example the bioconjugation of antibodies and cytotoxics and fill/finish – can reduce production time and cost to improve supply chain efficiency, said Johnson.
CDMO Lonza agreed that for a pharma or biotech company developing ADCs, there are “clear advantages” to outsourcing to a firm that offers a variety of manufacturing services.
“The ADC market is rapidly evolving and we’re seeing an increasing variety of molecules – for example novel payloads or using site-directed conjugation technologies,” commercial development head of bioconjugates at Lonza Pharma & Biotech, Laurent Ducry, told us.
“At our Visp site in Switzerland, customers have access to an end-to-end solution that incorporates API [active pharmaceutical ingredient] development and manufacturing – including HPAPI [highly potent API] – as well as conjugation,” he added.