Ajinomoto Althea Inc. has 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.