Pfenex Inc. Awards Althea Technologies a Contract for cGMP Manufacturing of Circumsporozoite Protein from Plasmodium falciparum, a Key Malaria Antigen
SAN DIEGO – October 24, 2012 — Pfenex Inc. today announced that it has awarded Althea Technologies a contract for the current Good Manufacturing Practice (cGMP) manufacturing of circumsporozoite protein (CSP) from Plasmodium falciparum, an important and proven component of an effective malaria vaccine. Althea Technologies will implement the cGMP-ready Pfēnex Expression Technology™-based production process that was developed at Pfenex over the past several months. Processes for several additional malaria antigens are currently being developed at Pfenex.
Funding will be provided by Science Applications International Corporation (SAIC) through its Malaria Vaccine Production and Support Services contract (N01-AI-05421) with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. Pfenex is a subcontractor to SAIC under this award.
“We are pleased to award this contract to Althea Technologies,” stated Bertrand C. Liang, Chief Executive Officer, “Pfēnex Expression Technology has made the high titer production of full-length, soluble, active CSP antigen a reality; recombinant expression of full-length, stable CSP has eluded researchers for years and with our protein expression platform we have overcome those challenges. With Althea we can rapidly implement the large-scale cGMP production of the CSP necessary for future human clinical studies to support NIAID’s malaria vaccine development efforts.”
“The availability of cGMP-produced active, full-length CSP antigen will provide a versatile tool to explore and evaluate clinically novel candidates with various platforms and potentially accelerate development efforts to achieve a second-generation CSP-based malaria vaccine that enhances efficacy and accessibility to the community,” added Dr. Annie Mo, Program Officer of Parasitology and International Program Branch, DMID.
Rick Hancock, President and Chief Executive Officer of Althea Technologies said, “We are honored to be selected for this contract. This collaboration with Pfenex for the production of a malaria vaccine embodies Althea’s commitment to advancing lifesaving interventions that tackle public health challenges. We are looking forward to this opportunity to support NIAID/Pfenex’s program and leverage our experience and expertise in vaccine technology transfer, scale-up, and clinical manufacturing.”
About Pfenex Inc.
Pfenex Inc. is a protein production company leveraging the unique and powerful Pfēnex Expression Technology platform based on the microorganism, Pseudomonas fluorescens, for the production of research proteins, reagent proteins, biosimilars, and innovator biopharmaceuticals. For more information, visit www.PFENEX.com.
About Althea Technologies, Inc.
Althea Technologies 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, lyophilization cycle, 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.Back to Articles