Althea’s New Drug Formulation Technology Gains Attention from Two More Top Pharmaceutical Companies
SAN DIEGO – March 31, 2015 — Ajinomoto Althea, Inc. (“Althea”), a leading provider of biopharmaceutical contract development and manufacturing services, announced today that it has added two more top pharmaceutical companies to its growing list of partners in developing and manufacturing cGMP-produced crystal based drug products using Althea’s Crystalomics® drug delivery technology. With these additional companies, a total of 4 out of 10 of the world’s top pharmaceutical companies have already signed agreements with Althea since Ajinomoto’s acquisition of Althea and the Crystalomics® technology. This proprietary Crystalomics® formulation technology is utilized to formulate and manufacture crystal suspensions of developed drug substance. Often, drug manufacturers encounter stability and delivery challenges for protein products including antibodies that require delivery at high concentration and low viscosity or must be administered frequently. Products formulated with the Crystalomics® technology can be delivered at low viscosity and high concentrations in a small volume. In addition, the Crystalomics® technology enables extended release of a week or more, transforming daily to weekly injections.
David Enloe, President and CEO of Althea, states, “We are very pleased to see a growing number of pharmaceutical companies implementing work with our Crystalomics® technology. We welcome the opportunity to support this growing list of partners by delivering regulatory compliant crystal suspension products that will overcome their high concentration delivery challenges. The Crystalomics® formulation technology has tremendous potential in drug development, promoting enhanced outcomes of drug treatments and improving compliance.”
Althea’s crystal suspension manufacturing services deliver a comprehensive set of service capabilities including Crystalomics® process development, in-process and release testing analytics, equipment qualification and validation, and complete cGMP bulk manufacturing fill and finish production.
About Ajinomoto Althea, Inc. Althea is a fully integrated, contract development and manufacturing organization located in San Diego, CA providing clinical and commercial product development services. Althea 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, Althea offers comprehensive development services including: upstream and downstream process development, analytical development, lyophilization cycle, complex formulation, product release and ICH-compliant stability testing. Althea’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. Althea also has an innovative and proven recombinant protein expression technology called Corynex® technology.