From Concept to Completion

Ajinomoto Althea is a contract developer and manufacturer of biopharmaceutical and injectable products, with fully integrated product development and CGMP manufacturing expertise to support client projects from preclinical development through commercial supply. Each project program at Ajinomoto Althea is tailored to the specific needs of your product, allowing you to leverage our entire integrated manufacturing approach or just the parts you need. While realizing all the tangible benefits of consolidating your development and manufacturing steps, you’ll also have the confidence of knowing that your product is being championed by seasoned professionals who boast an impressive track record of more than 300 cell banks, 160 CGMP protein and plasmid DNA lots, and more than 1,800 CGMP fill– finish lots delivered to date.

Biologics Manufacturing: Recombinant Protein & Plasmid

Whether it is protein or plasmid production, Ajinomoto Althea’s experienced staff can take your microbially expressed product from cell banking to final filled product. Because of Ajinomoto Althea’s seamless integration, your product will be smoothly transferred from process development — where our group will develop processes to manufacture the highest quality products — to our CGMP manufacturing facility. With fermentor capacities up to 1,000 L, Ajinomoto Althea can take your product through clinical development and commercialization.

Protein Analytics: Analytical Method Development and Product Characterization

A successful biopharmaceutical product depends on a comprehensive and well-designed analytical program. Ajinomoto Althea offers core services of method development and validation, product characterization, comparability studies, reference standard qualification, and stability and release testing. Our scientists have the experience and knowledge to address the unique requirements of each molecule, using multiple methods for characterization. Ajinomoto Althea also truly values partnership with our clients, so it is important to us that we share analytical data and engage in open dialogue and technical discussions with our clients to promote faster and better development of your product.

Crystalomics^®: Protein Crystallization Technology

Ajinomoto Althea’s Crystalomics^® technology allows proteins and other large molecules to be formulated as crystals in suspension. This formulation has the potential to solve drug delivery problems for drugs that must be delivered at high concentration and low viscosity or administered frequently. Products formulated with Crystalomics^® can be delivered at a high concentration in a small volume and can have extended release of a week or more, ensuring increased stability and patient safety.

Corynex™: Recombinant Protein Expression System

Ajinomoto Althea’s innovative Corynex™ Recombinant Protein Expression System is a novel protein expression system that can produce complex proteins using a specially developed gram-positive bacterium, Corynebacterium glutamicum. Conventional microbial-based expression systems require multiple purification steps and additional subsequent refolding. This breakthrough, patented system overcomes those challenges and allows for the isolation of higher yields of biologically active proteins with accurate folding, increased purity with fewer host proteins and no endotoxins. Using our proprietary Corynex™ expression system, Ajinomoto Althea minimizes costly purification steps, resulting in improved delivery of peptides and proteins.

Aseptic Fill and Finish: Vials, Syringes, Lyophilization

At Ajinomoto Althea, we can provide you with a reliable supply of final product in vials or prefilled syringes for every stage of development and commercialization. We have tremendous experience with complex formulations, including liposomes and nanoparticles, conjugates, and adjuvants, and are commited to the delivery of stable and high-quality product. If your product requires the additional stability of lyophilization, we can optimize the lyophilization cycle and lyophilize your product in our facility.

As one of the few fully-integrated development and manufacturing service providers in the industry, Ajinomoto Althea can partner with you to consolidate many of the steps in your supply chain from drug substance to final product to reduce the time, cost, and risk associated with moving product across multiple service providers. Contact us today to discuss how Ajinomoto Althea can drive value to your drug development and manufacturing program.

About the Author

Author Details
Kristi Woolery is the marketing coordinator at Ajinomoto Althea, 11040 Roselle Street, San Diego, CA 92121; 1-858-882-0123, [email protected]; www.altheatech.com.