Biopharmaceutical contract development and manufacturing organization (CDMO) Ajinomoto Althea earlier today announced that it is expanding its existing biological drug product manufacturing operations to include highly active materials such as Antibody-drug Conjugates or ADCs. The new facility is located in close proximity to existing Althea operations in San Diego, CA.
Oncology therapeutics including Antibody-drug Conjugates and Highly Potent Active Pharmaceutical Ingredients (HPAPIs) represent one of the fastest growing segments of the pharmaceutical industry requiring specialized manufacturing facilities and infrastructure to ensure safe handling, manufacture, and delivery. 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. The 57,000 square foot facility enables the company to offer clients a simplified manufacturing supply chain service from a single United States based location.
Very low Occupational Exposure Limit
The facility has been designed for safe handling and manipulation of very low Occupational Exposure Limit (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. Althea is working with Environmental Health & Safety (EHS) 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,” noted Jason Brady, Ph.D., Althea’s Senior Director and Business Head for Antibody-drug Conjugates.
Althea took occupancy of the new facility on May 1, 2015. Construction and retrofitting has already commenced. The company 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’s expansion is one of many projects by global CDMOs, including Lonza, Novasep, Piramal and SAFC to add to ADC and HPAPI manufacturing capabilities and capacity around the world.