​​Ajinomoto Althea Launches Process & Analytical Development Services for ADC Therapeutics

Ajinomoto Althea, Inc., a leading provider of biopharmaceutical contract development and manufacturing services, 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.

Althea announced the first phase of its ADC and cytotoxic service offerings. Process and Analytical Development laboratories will be available for client programs in January 2016. These laboratories provide clients with services that support their 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 pre-clinical studies. The Analytical Development labs will support process development services such as cleaning verification, raw material identification testing, ADC characterization assays, as well as necessary safety and potency assays.

Jason Brady, PhD, Sr. Director and Business Head, ADCs, states “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 towards offering ADC developers a simplified supply chain, including bioconjugation, fill and finish, and process and analytical development, all within a single US-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. This 57,000-sq-ft facility will enable Althea to offer clients a simplified manufacturing supply chain service from a single United States based location. 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 early clinical phase through commercial launch and supply will be accommodated at this new facility.

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. Althea’s formulation technology platform includes Crystalomics^®, a proprietary technology that offers a formulation solution for large molecule products that must be delivered at high concentrations or as sustained release formulations. Althea also has an innovative and proven recombinant protein expression technology called Corynex^® technology. For more information visit www.altheaCMO.com.