Goodwin Biotechnology, a biological contract development and manufacturing organization (CDMO) that specializes in bioprocess development and GMP manufacturing of biopharmaceuticals utilizing mammalian cell culture expression systems and bioconjugation technologies, was selected by Panacea Pharmaceuticals to complete a novel fill/finish project, as well as quality control release and stability testing for a therapeutic, nanoparticle cancer vaccine based on the human Aspartyl (Asparaginyl) β-Hydroxylase (HAAH) tumor-specific protein to support Phase I clinical trials in patients with various solid tumor cancers.

“Over the last year, we partnered with Goodwin Biotechnology on a bioconjugation project and have found them to be extremely responsive and flexible. They had an innovative approach to address some rather significant challenges in an effort to move our project forward,” said Steven Fuller, chief operating officer, Panacea Pharmaceuticals. “When we identified the need to select a company for our fill/finish project that involves a unique injector cartridge filling procedure for our other lead compound, we evaluated Goodwin’s capabilities and we were pleased to find out that their approach to niche fill/finish projects was just as flexible and solutions oriented.”

“We are pleased to have Panacea Pharmaceuticals work with us on their two lead compounds,” said SooYoung Lee, chief operating officer, Goodwin Biotechnology. “While being selected for a bioconjugation or cell culture-based project is typical, based on the many years of successful track records and our commitment to bring advances to those fields, it is more rewarding to know that our investment to build and offer the comprehensive infrastructure required to deliver ready-for-clinical-trials, Final Vialed Product (FVP) and provide integrated solutions to meet specific and unique requirements of our clients has been helpful for Panacea.”

Goodwin Biotechnology operates an ISO5 cGMP filling suite that can accommodate liquid filling of a wide range of configurations to meet specific and unique clients’ requirements.