Ajinomoto Althea Expands Capacity of Fill Finish Manufacturing
Ajinomoto Althea, Inc. recently announced it is expanding the capacity of its Fill and Finish operations through the addition of a second manufacturing shift. Althea’s contract manufacturing business has experienced exceptionally strong growth driven by biotech companies outsourcing to Althea sterile fill and finish parenteral manufacturing to support their clinical and commercial drug programs. In 2015, Althea’s business grew by 30%, and it expects to continue on this steep growth trajectory in upcoming years. Althea’s second shift will come on-line in early June, increasing the number of manufacturing slots for commercial and clinical drug programs, thereby significantly reducing lead times from project kickoff to fill date.
“We are very pleased and eager to provide this additional fill and finish capacity to all of our clients. We recognize and appreciate the need for shorter lead times and flexible timelines, which are critical to developers of biologics-based drug products. The addition of this second manufacturing shift will allow us to further accommodate the substantial increase in demand we’ve observed from our clinical and commercial partners,” said Chris Duffy, Senior Vice President of Operations.
To support this significant increase in its parenteral manufacturing capacity, Althea has invested in additional operational capabilities, more visual inspection suites, automated quality systems, and project management expansion. This expansion plan is one element of the growth strategies that Althea is deploying to accommodate not only the increased demand in its fill and finish business, but also in its microbial and plasmid DNA capabilities, its proprietary crystallization formulation technology (Crystalomics) programs, and its recently announced entry into the highly potent API and ADC bioconjugation and fill and finish services.
Althea is a fully integrated, contract development and manufacturing organization located in San Diego, CA, providing clinical and commercial product development services. Althea offers cGMP drug product filling in both vials and syringes, and production of microbial-derived recombinant proteins and plasmid DNA. In conjunction with these manufacturing operations, Althea offers comprehensive development services, including upstream and downstream process development, analytical development, complex formulation, product release and ICH-compliant stability testing. Althea’s formulation technology platform includes Crystalomics, a proprietary technology that offers a formulation solution for large molecule products that must be delivered at high concentrations or as sustained release formulations. Althea also has an innovative and proven recombinant protein expression technology called Corynex technology. For more information, visit www.altheaCMO.com.
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