Ajinomoto Althea Expands Manufacturing Capabilities to ADC Fill Finish & Bioconjugation

Ajinomoto Althea, Inc. 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.

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-sq-ft facility will enable Althea 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 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.

“Currently, there is limited capacity of high containment manufacturing in the US,” said Jason Brady, PhD, Sr. Director and Business Head ADCs. “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 in May 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.

Althea is a fully integrated, contract development and manufacturing organization located in San Diego, CA providing clinical and commercial product development services. Althea offers cGMP drug product filling in both vials and syringes, and production of microbial-derived recombinant proteins and plasmid DNA. In conjunction with these manufacturing operations, Althea offers comprehensive development services, including upstream and downstream process development, analytical development, complex formulation, product release, and ICH-compliant stability testing. For more information, visit www.altheaCMO.com.