Ajinomoto Althea, Inc. Launches Process and Analytical Development Services for Antibody Drug Conjugates (ADCs) Therapeutics

SAN DIEGO – December 10th, 2015 — Ajinomoto Althea, Inc. (“Althea”), 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. Today 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, Ph.D., 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 square foot 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.

ア지노モト・アルテア社について

アルテアは、カリフォルニア州サンディエゴに拠点を置く、完全に統合された受託開発・製造機関（CDMO）であり、臨床および市販製品の開発サービスを提供しています。アルテアは、バイアルおよびシリンジへのcGMP準拠の医薬品充填、ならびに微生物由来の組換えタンパク質およびプラスミドDNAの製造を行っています。 これらの製造業務と併せて、アルテアは、上流・下流プロセス開発、分析開発、複雑な製剤開発、製品リリース、およびICH準拠の安定性試験を含む包括的な開発サービスを提供しています。アルテアの製剤技術プラットフォームには、高濃度での投与や徐放性製剤として提供される必要がある高分子製品向けの製剤ソリューションを提供する独自技術「Crystalomics®」が含まれています。また、アルテアは「Corynex®」技術と呼ばれる、革新的かつ実績のある組換えタンパク質発現技術も有しています。