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Ajinomoto Althea, Inc.





Company Headquarters

11040 Roselle Street
San Diego, CA 92121
United States

Company Description





Who We Are

Ajinomoto Althea, Inc. is fully integrated contract development and manufacturing organization providing clinical drug process development and manufacturing services to global biotechnology and pharmaceutical companies. Althea has the capacity to support early-stage clinical requirements through commercial manufacturing. Althea is a leading expert in aseptically fi lling drug product into vials and syringes, and our focused expertise and capabilities make us one of the industry’s top leaders for cGMP microbial fermentation.

Services Offered

Process Development
Successful process development enables a smooth and rapid path from cell line development to commercial product delivery. Althea’s complete range of Process Development capabilities offer the tools to address your needs, whether they be in producing small quantities of proteins for early testing or in developing robust, reliable and scalable processes that will enable a strong commercial advantage. Althea’s highly knowledgeable Process Development team will develop and characterize a robust manufacturing process to ensure consistent cGMP manufacturing performance for Phase I through Phase III, at which point Process Validation is implemented to secure a commercial quality process to deliver reliable product supply.

Bulk Drug Substance Manufacturing – Recombinant Protein & Plasmid
Althea’s focused expertise and capabilities in cGMP production of microbial-based biotherapeutics make us one of the industry’s top leaders for microbial fermentation. Whether it is protein or plasmid production, Althea’s experienced staff can take your microbially-expressed product from cell banking to fi nal fi lled product. As your program advances in the clinic, you can be assured that Althea will provide the capacity and quality to scale your process to larger product volume requirements without changing facilities Althea can take your product through clinical development and commercialization.

Drug Product, Aseptic Fill & Finish – Vials, Syringes, Lyophilization
Althea offers a unique range of aseptic fi lling in vials or prefi lled syringes to address production needs that span from small scale early stage clinical products to larger scale commercial products. Our broad range of equipment and expertise paired with our fl exibility and responsiveness, provide you with the capacity to advance your projects through all stages of clinical and commercial development. The formulation scientists at Althea have extensive knowledge and expertise in manufacturing a variety of complex formulations, including liposomes & nanoparticles, conjugates, crystallized proteins, adjuvants, and viscous products. Althea offers cGMP lyophilization services in conjunction with our Fill Finish capabilities.

Analytical Services – Analytical Method Development & Product Characterization
Althea’s analytical programs satisfy regulatory requirements and work to assure the success of the clinical program. Althea offers core services of method development and validation, product characterization, comparability studies, reference standard qualifi cation and stability and release testing. The Analytical Scientists customize a phase-appropriate analytical program to the specifi c needs of your unique molecule to ensure a comprehensive understanding and characterization of the molecule for each stage of development and commercialization.

 

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