Ajinomoto Althea Issued Patent for Crystallizing mAbs
Ajinomoto Althea Inc., a contract development and manufacturing organization, has received an US Patent (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.
Althea’s Crystalomics Formulation Technology was developed to address the 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.
In addition to monoclonal antibodies, Crystalomics technology is applicable across a wide range of molecules: recombinant proteins, peptides, DNA and antibiotics.
Althea offers cGMP drug product filling in both vials and syringes, and production of microbial-derived recombinant proteins and plasmid DNA.
Source: Ajinomoto Althea