12.14.15
Ajinomoto Althea, Inc. is expanding its biologic drug product manufacturing operations to include highly active materials such as Antibody Drug Conjugates (ADCs). The new facility is located near Althea’s existing operations in San Diego, CA. Process and analytical development labs will be available for client programs in January 2016.
The labs provide services to support early stage ADC product development efforts and are equipped to perform 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, ADC characterization assays, as well as necessary safety and potency assays.
Additionally, the new 57,000 sq.-ft. manufacturing facility will include areas dedicated to bioconjugation, formulation, purification, quality control, and aseptic fill finish including lyophilization. The facility can accommodate projects from early clinical phase through commercial launch and supply, and has been designed for safe handling and manipulation of very low OEL compounds while maintaining aseptic conditions and GMP compliance.
Jason Brady, Ph.D., senior director and business head, ADCs, 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 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.”
The labs provide services to support early stage ADC product development efforts and are equipped to perform 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, ADC characterization assays, as well as necessary safety and potency assays.
Additionally, the new 57,000 sq.-ft. manufacturing facility will include areas dedicated to bioconjugation, formulation, purification, quality control, and aseptic fill finish including lyophilization. The facility can accommodate projects from early clinical phase through commercial launch and supply, and has been designed for safe handling and manipulation of very low OEL compounds while maintaining aseptic conditions and GMP compliance.
Jason Brady, Ph.D., senior director and business head, ADCs, 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 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.”