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Goodwin, Aspyrian partner for cGMP manufacturing of new antibody drug conjugate

US-based Goodwin Biotechnology has entered into an agreement with Aspyrian Therapeutics for the technology transfer, process development, scale-up, and cGMP manufacturing of a new Antibody Drug Conjugate (ADC) for use in Phase I clinical trials.

Aspyrian has received an exclusive license from the National Cancer Institute for a new ADC technology platform, Near-infrared Photoimmunotherapy (PIT), which is expected to offer highly efficient and selective ablation of tumor cells while sparing damage to critical structures adjacent to the tumor.

The company said that as the payload in the ADC is inert until it is both in the tumor and activated by near-infrared (NIR) light, it overcomes the dose-limiting adverse effects that have hindered the development of conventional, toxin-loaded ADC systems.

Goodwin Biotechnology chief operating officer SooYoung Lee said the company is happy to have been selected to partner with Aspyrian Therapeutics for this ADC project.

"This important project is a testament to our experience and expertise in bioconjugation that has been developed and refined over more than a decade," Lee said.

"This initiative has been led by Muctarr Sesay, PhD, Vice President of Process Development who is one of the pioneers in process development and cGMP manufacturing of many ADCs and biologic drug conjugates, which Goodwin has successfully manufactured for human clinical studies."

Aspyrian Therapeutics chief scientific officer Miguel Garcia-Guzman said the technical expertise that Goodwin Biotechnology offers in the field of bioconjugation, coupled with the responsiveness and flexibility they exhibited during the selection process, made them the obvious choice.

"Our mission is to leverage the potential of the PIT platform by developing a pipeline of proprietary and partnered ADC products, and this collaboration represents a critical milestone in this endeavour," Garcia-Guzman said.