Biopharmaceutical contract development and manufacturing services company Ajinomoto Althea recently announced that it is expanding its existing biological drug product manufacturing operations to include highly active materials such as Antibody Drug Conjugates or ADCs. The new facility, located  in close proximity to existing Althea operations in San Diego, CA, is expected to increase Althea ability to offer a fully integrated, contract development and manufacturing services as well as clinical and commercial product development services.[1]

ADC and cytotoxic service offerings
Following the announcements about the expansion of it’s manufacturing operations, the company today announced the first phase of its antibody-drug conjugate /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 antibody-drug conjugate 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, antibody-drug conjugate characterization assays, as well as necessary safety and potency assays.

“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,” explained Jason Brady, Ph.D., Senior Director and Business Head, Antibody-drug Conjugates

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Additional manufacturing solution
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 square foot facility will enable the company 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.


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