SAN DIEGO – [6.16.15] — Ajinomoto Althea, Inc. (“Althea”), a leading provider of biopharmaceutical contract development and manufacturing services announced today that it has officially received its European GMP certificate from the Health Products Regulatory Authority (HPRA) for commercial aseptic filling and testing. The HPRA conducted a five day on-site inspection which commenced on February 2, 2015. Upon conclusion of the inspection, the agency reported that there were no critical or major observations to address. By issuing this certification, the HPRA officially recognizes that Althea’s manufacturing controls, laboratory controls and overall quality systems are in strict compliance with the European GMP requirements. Furthermore, on May 19, 2015, Althea passed two additional European Pre-Approval Inspections (PAI) for drug applications submitted by two of its clients for new commercial drug programs. Both the European GMP certification and successful commercial PAIs highlight Althea’s readiness to serve the European commercial markets as a full service contract manufacturing and testing organization for commercial drug product programs.
“Althea is very pleased to announce this new European certification paired with two highly successful PAI inspections. This is further evidence of our continued commitment to global GMP compliance.” stated Elaine Sapinoso, Vice President of Quality and Regulatory of Althea. “These accomplishments validate the hard work and investments we have made over the years to maintain our quality systems at a level that meets current regulatory expectations. We take pride in offering quality services to our clients while ultimately ensuring safety of the patients receiving these new drugs.”
In addition to pursuing European GMP approval, Althea continues to invest and expand in quality systems, facilities and operational capabilities to support the increased demand that the company has experienced in both its Drug Substance and Drug Product business segments. Althea provides a broad range of manufacturing service capabilities including cGMP bulk manufacturing filling in vials and syringes, microbial-based biologics manufacturing, Crystalomics® crystal suspension technology, process development, in-process and release testing analytics, equipment qualification, and validation.
About Ajinomoto Althea, Inc. Ajinomoto Althea, Inc. is a fully integrated, contract development and manufacturing organization located in San Diego, CA providing clinical and commercial product development services. Ajinomoto Althea, Inc. offers cGMP drug product filling in both vials and syringes, and production of microbial-derived recombinant proteins and plasmid DNA. In conjunction with these manufacturing operations, Ajinomoto Althea, Inc. offers comprehensive development services including: upstream and downstream process development, analytical development, lyophilization cycle, complex formulation, product release and ICH-compliant stability testing. Ajinomoto Althea Inc.’s formulation technology platform includes Crystalomics®, a proprietary technology that offers a formulation solution for large molecule products that must be delivered at high concentrations or as sustained release formulations. Ajinomoto Althea also has an innovative and proven recombinant protein expression technology called Corynex® technology.