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Althea is expanding its existing biological drug product manufacturing operations to include highly active materials, such as antibody-drug conjugates, in a new facility near San Diego, CA.
Ajinomoto Althea, a biopharmaceutical CDMO, is expanding its existing biological drug product manufacturing operations to include highly active materials, such as antibody-drug conjugates (ADCs), the company announced on Oct. 14, 2015. The new facility is located in close proximity to the company’s existing operations in San Diego, CA.
Oncology therapeutics, including ADCs and highly potent APIs (HPAPIs), represent one of the fastest-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 manufacturing facility will include areas dedicated to bioconjugation, formulation, purification, quality control, and aseptic fill/finish, including lyophilization. This 57,000 ft2 facility will enable the company to offer clients a simplified manufacturing supply-chain service from a single US-based location. The facility has been designed for safe handling and manipulation of very low 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 environmental health and safety personnel and regulatory agencies to address topics specific to high-containment manufacturing in the design, construction, and operation of the new facility.
“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,” stated Jason Brady, senior director and business head of ADCs, in the press release.
Althea took occupancy of the new facility on May 1, 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.