Ajinomoto Althea, Inc. Expands Manufacturing Capabilities to ADC Fill Finish and Bioconjugation
SAN DIEGO – October 14th, 2015 — Ajinomoto Althea, Inc. (“Althea”), a leading provider of biopharmaceutical contract development and manufacturing services, today 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.
Oncology therapeutics including ADCs and HPAPIs (Highly Potent Active Pharmaceutical Ingredients) represent one of the fasting growing segments of the pharmaceutical industry. ADCs and HPAPIs require specialized manufacturing facilities and infrastructure to ensure safe handling, manufacture, and delivery of these products. 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 (Occupational Exposure Limit) 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 working with EHS (Environmental Health & Safety) and regulatory agencies to address topics specific to high containment manufacturing in the design, construction, and operation of the new facility.
Jason Brady, Ph.D., Sr. Director and Business Head ADCs, states, “Currently, there is limited capacity of high containment manufacturing in the United States. Althea is excited to make this significant expansion of our service offerings to address the needs of the ADC market as well as other highly potent products. Given our existing core capabilities in complex biologics formulation and aseptic filling, this investment in ADC and HPAPI fill finish manufacturing is a natural progression and logical step for Althea.”
Althea took occupancy of the new facility on May 1st, 2015. Construction and retrofitting has already commenced. Althea will be executing services from the new facility as soon as Q2 2016 with full manufacturing activities coming online the first half of 2017.
Über Ajinomoto Althea, Inc.
Althea ist ein vollintegriertes Auftragsentwicklungs- und Produktionsunternehmen mit Sitz in San Diego, Kalifornien, das Dienstleistungen im Bereich der klinischen und kommerziellen Produktentwicklung anbietet. Althea bietet die cGMP-konforme Abfüllung von Arzneimitteln in Fläschchen und Spritzen sowie die Herstellung von mikrobiell gewonnenen rekombinanten Proteinen und Plasmid-DNA an. Neben diesen Fertigungsaktivitäten bietet Althea umfassende Entwicklungsdienstleistungen an, darunter: Upstream- und Downstream-Prozessentwicklung, analytische Entwicklung, komplexe Formulierung, Produktfreigabe und ICH-konforme Stabilitätsprüfungen. Zur Formulierungstechnologieplattform von Althea gehört Crystalomics®, eine firmeneigene Technologie, die eine Formulierungslösung für großmolekulare Produkte bietet, die in hohen Konzentrationen oder als Formulierungen mit verzögerter Freisetzung verabreicht werden müssen. Althea verfügt außerdem über eine innovative und bewährte Technologie zur Expression rekombinanter Proteine, die sogenannte Corynex®-Technologie.
