Goodwin selected to make bispecific antibody candidate for Russian firm

02-May-2016 - Last updated on 11-Dec-2023 at 11:15 GMT

Image: iStock/CreativaImages

Distance and time differences are not barriers when choosing a biologics CMO, says Goodwin Biotechnology which has won a bispecific antibody process and scale-up contract from Russia’s IBC Generium.

Russian research company International Biotechnology Center (IBC) Generium has selected the Florida-based biological contract development and manufacturing organisation (CDMO) to support development and manufacture of its blood cancer candidate GNR‐047, an early-stage IgG‐based, bispecific antibody.

“All the work is being performed at our facility in Plantation, Florida, and we will provide fully manufactured and characterized IgG-based bispecific antibodies to Generium to support their early stage clinical trials,” Goodwin director David Cunningham told Biopharma-Reporter.com.

Goodwin will utilise its mammalian cell culture expression systems and bioconjugation technologies for the assay and process technology transfer, process scale‐up, and cGMP manufacturing of the candidate as it goes into Phase I clinical.

According to IBC Generium, Goodwin came “highly recommended” by one of its primary collaborators, but we asked Cunningham whether the logistics of using a CDMO based almost 5,000 miles is a problem for a client.

“Over the last two decades, we have partnered with clients from Eastern and Western Europe, Asia, and, of course North America. We ensure that distance and differences in time zones are not a barrier,” he said.

“We ensure successful relationships by assembling a Project Team with a single Goodwin Project Manager (PM) as the point-of-contact. The PMs are advocates for our clients within Goodwin, and they ensure that project timelines are met, and that information is communicated to our clients in a responsive and timely manner.”

Scale-up

IBC Generium’s candidate is in its early-stages of development and thus fits in with Goodwin’s focus on clinical manufacturing up to phase III.

Last June, the CDMO was selected to complete the process development, scale-up and manufacture the antibody-drug candidate (ADC) RM-1929 for Aspyrian Therapeutics.

Goodwin has also manufactured monoclonal antibodies for Actinium Pharmaceuticals and Alethia Biotherapeutics, and has done other fill/finish work for Panacea Pharmaceuticals.

The firm’s strategy is to be ready for commercial manufacturing when clients’ BLAs are approved, Cunningham said. “Towards that end, we are in the process of preparing for commercial manufacturing for one of our clients who is anticipating their BLA approval shortly.”