Ajinomoto Althea, Inc. Expands Manufacturing Capabilities to ADC Fill Finish and Bioconjugation
SAN DIEGO – October 14th, 2015 — Ajinomoto Althea, Inc. (“Althea”), a leading provider of biopharmaceutical contract development and manufacturing services, today announced it is expanding its existing biological drug product manufacturing operations to include highly active materials such as Antibody Drug Conjugates (ADCs). The new facility is located in close proximity to existing Althea operations in San Diego, CA.
Oncology therapeutics including ADCs and HPAPIs (Highly Potent Active Pharmaceutical Ingredients) represent one of the fasting growing segments of the pharmaceutical industry. ADCs and HPAPIs require specialized manufacturing facilities and infrastructure to ensure safe handling, manufacture, and delivery of these products. Althea’s new state-of-the-art manufacturing facility will include areas dedicated to bioconjugation, formulation, purification, quality control, and aseptic fill finish including lyophilization. This 57,000 square foot facility will enable Althea to offer clients a simplified manufacturing supply chain service from a single United States based location. The facility has been designed for safe handling and manipulation of very low OEL (Occupational Exposure Limit) compounds while maintaining aseptic conditions and GMP compliance. Client projects from early clinical phase through commercial launch and supply will be accommodated at this new facility. Althea is working with EHS (Environmental Health & Safety) and regulatory agencies to address topics specific to high containment manufacturing in the design, construction, and operation of the new facility.
Jason Brady, Ph.D., Sr. Director and Business Head ADCs, states, “Currently, there is limited capacity of high containment manufacturing in the United States. Althea is excited to make this significant expansion of our service offerings to address the needs of the ADC market as well as other highly potent products. Given our existing core capabilities in complex biologics formulation and aseptic filling, this investment in ADC and HPAPI fill finish manufacturing is a natural progression and logical step for Althea.”
Althea took occupancy of the new facility on May 1st, 2015. Construction and retrofitting has already commenced. Althea will be executing services from the new facility as soon as Q2 2016 with full manufacturing activities coming online the first half of 2017.
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.
