Ajinomoto Althea, Inc. is expanding its existing biologic drug product manufacturing operations to include highly active materials including Antibody Drug Conjugates (ADCs) and HPAPIs (Highly Potent Active Pharmaceutical Ingredients). The new facility is located near Althea’s operations in San Diego, CA. 
 
Oncology therapeutics such as ADCs and HPAPIs are among the fasting growing segments in the pharma industry, and require specialized manufacturing facilities and infrastructure to ensure safe handling, manufacture, and delivery of these products.
 
The new 57,000 sq.-ft. manufacturing facility will include areas dedicated to bioconjugation, formulation, purification, quality control, and aseptic fill finish including lyophilization . 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 . Althea can support client projects from early clinical phase through commercial launch and supply at this new facility. 
 
Jason Brady, Ph.D., senior director and business head ADCs, said, “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.”
 
Construction is underway and services from the new facility are expected to begin as soon as 2Q16, with full manufacturing activities coming online 1H17.