Ajinomoto Althea, Inc. (“Althea”), a leading provider of biopharmaceutical contract development and manufacturing services has announced that it has officially received its European GMP certificate issued by the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA conducted an on-site inspection on June 19, 2014 that yielded no critical or major observations. This certification provides clearance to Althea to test commercial drug product for the European market. By issuing this certification, the MHRA officially recognizes that Althea’s quality control testing and overall quality systems are in strict compliance with the European GMP requirements.
“Althea is proud of this important regulatory milestone. We are well known for our impeccable regulatory track record in the US and now are very pleased to expand our commercial testing capabilities for European clients,” stated David Enloe, President and CEO of Althea. “Knowing that our testing and quality processes meet both the stringent FDA and EMA quality requirements really signifies a great accomplishment by our team and supports our leadership position in the CMO market.”
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 biologics manufacturing (drug substance) and fill and finish (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. For more information visit us at www.altheatech.com.
Source – Althea