Althea launches development services for ADC therapeutics
Ajinomoto Althea, a leading provider of biopharmaceutical contract development and manufacturing services, 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 Althea’s existing operations in San Diego.
The company today announced the first phase of its ADC and cytotoxic service offerings. Process Development and Analytical Development laboratories will be available for client programs in January 2016. The laboratories provide clients with services that support the early-stage ADC product development efforts.
The Process Development labs are equipped to perform services such as bioconjugation, process development and optimization, ultrafiltration and diafiltration process development, as well as ADC material generation utilizing low occupation exposure limit (OEL) payloads for preclinical studies. The Analytical Development labs will support process development services such as cleaning verification, raw material identification testing and ADC characterization assays, as well as necessary safety and potency assays.
Jason Brady, Ph.D., senior director and business head of ADCs at Althea, said, “We are very excited to announce the implementation of this key first step of our ADC service offerings. Althea is very pleased with our progress toward offering ADC developers a simplified supply chain, including bioconjugation, fill and finish, and process and analytical development, all within a single U.S.-based location.”
In addition to the development labs, 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 will enable Althea to offer clients a simplified manufacturing supply chain service.
The facility has been designed for safe handling and manipulation of very low OEL compounds while maintaining aseptic conditions and GMP compliance. Client projects from the early clinical phase through commercial launch and supply will be accommodated at this new facility.