The two US contract manufacturing organisations (CMOs) will develop and manufacture cytotoxic antibody-drug conjugates (ADCs) together. Goodwin will offer clients pre-formulation development whilst Coldstream will provide clinical and commercial formulation development as well as ISO 5-compliant liquid and lyophilized Fill & Finish.
Speaking with Outsourcing-Pharma.com, Goodwin’s Director of Marketing & Administration, David Cunningham, said this partnership was not in response to any particular client’s needs, but rather a “very high demand within the biopharmaceutical sector, from small and virtual companies to large and established multinationals.”
Cunningham’s words join a number of comments across the industry as ADCs are becoming a popular offering for third-party manufacturers. Just last month Catalent entered the ‘niche’ market following its licensing deal for proprietary technology with Redwood Bioscience and told this publication ADCs are a fast growing area of development with many customers looking at them for their next generation of biologics.
‘Niche’ Market Waiting to Blossom
However, though the biopharma industry is looking towards ADCs, at present there are only two approved by the US Food and Drug Administration (FDA) as commercial drugs – Seattle Genetics’ Adcetris and Genentech’s Kadcyla.
“The economics and efficacy of ADCs have always been compelling,” continued Cunningham, “and the two firms, whose linker-payload technologies are used in the two approved ADCs, are only the vanguard of the anticipated ADC wave.
“More than 20 new ADCs are currently in clinical trials, and many hundreds more are in preclinical development and R&D stages,” he continued to add - sourcing, in part, data from World ADC conference in San Francisco 2012 - making ADC development and manufacture an alluring prospect.
CMO Competition
Fujifilm, Baxter International and Lonza are some of the larger CMOs who have been active in ADC investment in recent months and therefore we asked Cunningham how Goodwin would fit in with such company.
He told us that Goodwin is already established itself in this field with over ten years of experience in the bioconjugation arena.
“For highly potent bioconjugation, we plan to compete by offering high-quality, economical, compliant (including commercial manufacturing), and timely service in a customer-focused manner,” he said. “Some of the aforementioned large CMOs can only muster two or three of these five critical considerations, especially for emerging or virtual companies.”
Furthermore, the appeal of Goodwin’s proprietary linker technology platforms being “license-free and royalty-free” would, according to Cunningham be “an attractive option for even the large, multinational companies.”
The financial details of the collaboration were not disclosed but Goodwin’s staff will operate within Coldstream’s facilities in Lexington, Kentucky.