The contract development and manufacturing organisation has begun retrofitting a facility it bought in May near its existing site in San Diego. It plans to open the site in Q2 2016, with full operations at the start of 2017.
The finished 57,000 sq ft plant will offer bioconjugation, formulation, purification, quality control, and aseptic fill-finish including lyophilisation. Construction includes measures for safe handling of very low OEL (Occupational Exposure Limit) compounds under high containment, aseptic and GMP conditions.
US ‘lacks high containment’ sites
Althea said the site will offer clients contract services from early clinical phase to commercialisation.
Althea’s head of ADCs, Jason Brady, 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.”
Ajinomoto Althea was formed in 2013 when Tokyo-based chemical company Ajinomoto bought US CDMO Althea for $175m, including its biopharmaceutical production capabilities for microbial-derived recombinant proteins and plasmid DNA, upstream and downstream process development, analytical development, lyophilisation cycle, complex formulation, product release, ICH stability testing and cGMP vial and syringe filling.