Avista Pharma is registered with the Drug Enforcement Administration (DEA) to handle controlled substances, such as opioids. The manufacturing process to synthesize the small molecule, including cGMP production, also aligns well with the services provided by the company’s Durham facility.
“We are very optimistic about a positive outcome, as we have a great team of chemists working on this compound and are about to enter the critical stage of GMP manufacturing,” said Brian Heasley, manager of process chemistry, Avista Pharma and project lead. “Through this partnership, we are creating the synthetic small molecule that MMRF needs to continue their great work in protecting patients from opioid abuse or relapse.”
Through this collaboration, MMRF now has the small molecule component required to optimize the bioconjugation stage of the synthetic vaccine’s overall manufacturing process. GMP production of the molecule and associated conjugate vaccine to support clinical development will follow shortly thereafter.
“This is another great opportunity for us to demonstrate our organization’s capabilities in working with controlled substances and the synthesis of novel small molecules,” said Timothy Compton, vice president of business development, Avista Pharma. “We want to thank the Minneapolis Medical Research Foundation for enlisting our expertise and trusting us with the development of this important compound.”