Ajinomoto Althea, Inc. Launches Process and Analytical Development Services for Antibody Drug Conjugates (ADCs) Therapeutics
SAN DIEGO – December 10th, 2015 — Ajinomoto Althea, Inc. (“Althea”), a leading provider of biopharmaceutical contract development and manufacturing services, recently 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. Today Althea announced the first phase of its ADC and cytotoxic service offerings. Process and Analytical Development laboratories will be available for client programs in January 2016. These laboratories provide clients with services that support their early stage ADC product development efforts. The Process Development labs are equipped to perform services such as bioconjugation, process development and optimization, ultrafiltration and diafiltration process development, as well as ADC material generation utilizing low Occupation Exposure Limit (OEL) payloads for pre-clinical studies. The Analytical Development labs will support process development services such as cleaning verification, raw material identification testing, ADC characterization assays, as well as necessary safety and potency assays.
Jason Brady, Ph.D., Sr. Director and Business Head, ADCs, states, “We are very excited to announce the implementation of this key first step of our ADC service offerings. Althea is very pleased with our progress towards offering ADC developers a simplified supply chain, including bioconjugation, fill and finish, and process and analytical development, all within a single US-based location.”
In addition to the development labs, 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 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.
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.
