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.

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Althea 是一家位于加利福尼亚州圣地亚哥的全面整合型合同研发与生产组织（CDMO），提供临床和商业产品开发服务。Althea 提供符合 cGMP 标准的安瓿和注射器装药服务，以及微生物来源的重组蛋白和质粒 DNA 的生产。 除上述生产业务外，Althea 还提供全面的开发服务，包括：上游和下游工艺开发、分析开发、复杂制剂开发、产品放行以及符合 ICH 标准的稳定性测试。Althea 的制剂技术平台包含 Crystalomics®——一项专有技术，可为必须以高浓度给药或采用缓释制剂形式的大分子产品提供制剂解决方案。Althea 还拥有一项名为 Corynex® 技术的创新且经过验证的重组蛋白表达技术。