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.”

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

关于味之素阿尔西娅公司

Althea 是一家位于加利福尼亚州圣地亚哥的全面整合型合同研发与生产组织（CDMO），提供临床和商业产品开发服务。Althea 提供符合 cGMP 标准的安瓿和注射器装药服务，以及微生物来源的重组蛋白和质粒 DNA 的生产。 除上述生产业务外，Althea 还提供全面的开发服务，包括：上游和下游工艺开发、分析开发、复杂制剂开发、产品放行以及符合 ICH 标准的稳定性测试。Althea 的制剂技术平台包含 Crystalomics®——一项专有技术，可为必须以高浓度给药或采用缓释制剂形式的大分子产品提供制剂解决方案。Althea 还拥有一项名为 Corynex® 技术的创新且经过验证的重组蛋白表达技术。