Ajinomoto Althea, Inc. is expanding its existing biological drug product manufacturing operations to include services for antibody drug conjugates (ADCs) development as part of the first phase of the company's ADC and cytotoxic service offerings.

Althea's process and analytical development laboratories will provide services that support early-stage ADC product development efforts and perform bioconjugation, process development and optimization, ultrafiltration and diafiltration process development, as well as ADC material generation 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.

The 57,000-square foot facility will also include areas dedicated to bioconjugation, formulation, purification, quality control, and aseptic fill/finish, including lyophilization. Althea will begin offering these services in January 2016.

Source: Althea