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.
Über Ajinomoto Althea, Inc.
Althea ist ein vollintegriertes Auftragsentwicklungs- und Produktionsunternehmen mit Sitz in San Diego, Kalifornien, das Dienstleistungen im Bereich der klinischen und kommerziellen Produktentwicklung anbietet. Althea bietet die cGMP-konforme Abfüllung von Arzneimitteln in Fläschchen und Spritzen sowie die Herstellung von mikrobiell gewonnenen rekombinanten Proteinen und Plasmid-DNA an. Neben diesen Fertigungsaktivitäten bietet Althea umfassende Entwicklungsdienstleistungen an, darunter: Upstream- und Downstream-Prozessentwicklung, analytische Entwicklung, komplexe Formulierung, Produktfreigabe und ICH-konforme Stabilitätsprüfungen. Zur Formulierungstechnologieplattform von Althea gehört Crystalomics®, eine firmeneigene Technologie, die eine Formulierungslösung für großmolekulare Produkte bietet, die in hohen Konzentrationen oder als Formulierungen mit verzögerter Freisetzung verabreicht werden müssen. Althea verfügt außerdem über eine innovative und bewährte Technologie zur Expression rekombinanter Proteine, die sogenannte Corynex®-Technologie.
