San Diego-based Ajinomoto Althea Inc., a biopharmaceutical contract development and manufacturing company, has received clearance to test its commercial drug products for the European market.
“Althea is proud of this important regulatory milestone,” said David Enloe, president and CEO of Althea. “We are well known for our impeccable regulatory track record in the US and now we are very pleased to expand our commercial testing capabilities for European clients. 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 of drug substances 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.