Biopharmaceutical contract development and manufacturing services company, Ajinomoto Althea confirmed that announced it will soon open a GMP production suite in its newly constructed High Potency Products (HPP) commercial manufacturing facility located in San Diego, CA.
The company officially took ownership of the facility on May 1st, 2015 and a phased construction and retrofitting started in January 2016.
Althea is currently offering process development and analytical services to clients from the new facility and is expected to open for GMP bioconjugation and complex formulation in November 2017. Full manufacturing services including high containment fill and finish are expected to start Q4 2018.
Manufacturing contract
Althea has secured its first manufacturing contract for the new facility located just three miles from their current operations. According to a company spokesperson, this facility is uniquely designed to develop, manufacture, test, and release High Potency Products, including antibody-drug conjugates, Highly Potent Active Pharmaceutical Ingredients (HPAPIs), and other complex formulations of highly potent drugs.
Although the the terms of the deal are confidential, the scope of the project includea technology transfer, analytical method implementation, process validation, and GMP drug product manufacture in preparation for commercial launch of the client’s key therapeutic drug.
“The opening of our first production suite and signing of our first major contract is a clear sign that our investment which addresses the high containment manufacturing needs of our clients will positively impact [our] growing business. There is limited capacity in the marketplace and customers are eager to secure availability in a state-of-the-art facility managed by a company with an outstanding quality track record,” noted Jason Brady, Ph.D., Sr. Director and Business Head.
