Ajinomoto Althea, Inc. Announces Issuance of New US Patent for Manufacturing of Crystal Monoclonal Antibodies

SAN DIEGO, CA, May 17, 2016 — Ajinomoto Althea Inc., a leading provider of biotherapeutic contract development and manufacturing services, today announced that the United States Patent and Trademark Office has issued US Patent 9,310,379 covering methods to crystallize monoclonal antibodies for the purpose of scale up and cGMP manufacturing for therapeutic use. The patented methods are important for successful stabilization, storage and delivery of biologically active antibody crystals.

“This patent further validates Althea’s unique expertise and proprietary capabilities in the development and manufacturing of crystallized proteins for therapeutic use,” said Jennifer Cannon, Ph.D., Vice President, Commercial of Althea. “Typical crystallization methods involve slow diffusion processes that can take weeks, whereas Althea’s batch process for antibody crystallization can be completed within one day. Our pharmaceutical partners are very excited about the potential of this technology.”

Althea’s Crystalomics^® Formulation Technology was developed to address the unique challenges that arise during the development of therapeutic antibodies. Because of the size and complexity of these molecules, issues with viscosity, aggregation and stability are common. The Crystalomics^® group works with Althea’s clients to produce highly concentrated crystalline formulations with low viscosity, low volume administration and increased stability. In addition, crystalline suspensions may enable alternative routes of delivery that are more patient friendly.

Dr. Cannon continued, “Monoclonal antibody products are among the fastest growing drug classes in the world and make up over 75% of biologics development pipelines. We anticipate this trend to continue. Our patent portfolio and expertise positions Althea as the premier development partner for companies looking to develop low volume formulations that benefit both drug developers and patients.”

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n addition to monoclonal antibodies, Crystalomics^® technology is applicable across a wide range of molecules: recombinant proteins, peptides, DNA and antibiotics.

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, 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. For more information visit us at www.altheaCMO.com.