Althea Technologies, Inc.

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 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 of 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 250 cell banks, 150 cGMP protein and plasmid DNA lots, and more than 1,300 cGMP fill-and-finish lots delivered-to-date.

Biologics Manufacturing: Recombinant Proteins and Plasmids

Whether it is protein or plasmid production, Althea’s experienced staff can take your microbial-expressed product from cell banking to final filled product. Because of Althea’s seamless integration, your product will be smoothly transferred from process development, where our group will develop processes to manufacture the highest quality product, to our cGMP manufacturing facility. With fermentor capacities up to 1,000 L, 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. Offering core services of method development and validation, product characterization, comparability studies, reference standard qualification, and stability and release testing, our scientists take the approach that every molecule is unique, and requires multiple methods for characterization. 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

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

Aseptic Fill and Finish: Vials, Syringes, Lyophilization

At 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 committed 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.

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

About the Author

Author Details
Tristen Welch-Cross is marketing strategist for Althea Technologies, Inc., 11040 Roselle Street, San Diego, CA 92121; 1-858-882-0123, toll free 1-888-4ALTHEA; [email protected], www.altheatech.com.