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.

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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。