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.
아지노모토 알테아 주식회사에 대하여
Althea는 캘리포니아주 샌디에이고에 위치한 완전 통합형 계약 개발 및 제조 기업(CDMO)으로, 임상 및 상용 제품 개발 서비스를 제공합니다. Althea는 바이알 및 주사기 형태의 cGMP 의약품 충전 서비스와 미생물 유래 재조합 단백질 및 플라스미드 DNA 생산 서비스를 제공합니다. 이러한 제조 운영과 더불어, 알테아는 업스트림 및 다운스트림 공정 개발, 분석 개발, 복합 제형 개발, 제품 출하 승인 및 ICH 준수 안정성 시험을 포함한 포괄적인 개발 서비스를 제공합니다. 알테아의 제형 기술 플랫폼에는 고농도로 투여되거나 서방형 제형으로 제공되어야 하는 고분자 제품을 위한 제형 솔루션을 제공하는 독자적인 기술인 Crystalomics®가 포함되어 있습니다. 또한 알테아는 Corynex® 기술이라는 혁신적이고 검증된 재조합 단백질 발현 기술을 보유하고 있습니다.
