News
FDA Awards Precision Antibody Contract to Develop Monoclonal Antibodies for Influenza Vaccine Potency Assays
COLUMBIA, Md., October 20, 2011 —Precision Antibody™ announced today its selection by the United States Food and Drug Administration (FDA) to develop monoclonal antibodies to influenza virus antigens for both Influenza A and B. These antibodies will be used for in vitro assays to develop new vaccine potency assays. The term of the monoclonal development and antibody production contract is for one year with the option of five additional years.
On average, 5% to 20% of the U.S. population annually gets the flu. Over 200,000 people are hospitalized from flu complications with around 24,000 people succumbing to flu-related causes. There are two main types of influenza -- type A and type B -- both of which are responsible for the yearly flu outbreaks. Influenza B is specific to humans and can appear at any time of the year. Influenza A, which can be found in many kinds of animals including ducks, chickens and pigs, is comprised of 16 different subtypes. It normally arrives in early winter and spring, with the most well-known outbreak being the 2009 H1N1 influenza.
Current vaccine potency assays require an influenza strain-specific antigen standard and a strain-specific antibody standard. These standards are made for each new strain, included in the annual vaccine. This process must be repeated each year. The FDA is interested in stream lining the process by developing monoclonal antibodies that are type-specific rather than strain specific, so they can be more broadly used to assay the potency of all vaccine strains of a particular influenza subtype. Precision Antibody will apply its proprietary rapid antibody development technology to generate type-specific antibodies for up to 20 different influenza targets for the FDA.
“Since timely preparation of potency reagents by regulatory authorities is challenging and always a potential bottleneck in influenza vaccine production,” said Dr. Falko Schmeisser. “It is extremely important that additional approaches for reagent development be available, particularly in the event of an emerging pandemic influenza virus like the H1N1 in 2009.” Dr. Jun Hayashi, V.P. of Precision Antibody, said “we are honored to be selected and excited to be working with the FDA to develop these important antibodies. We are looking forward to initiating and growing this working relationship with Dr. Schmeisser’s group.”
About the Contract
This project is 100% supported with federal funds provided by the United States Food and Drug Administration (FDA). The content of this press release does not necessarily reflect the views or policies of the FDA, nor does mention of trade names, commercial products, or organizations imply endorsement by the U.S. government.
About Precision Antibody
Precision Antibody™ provides customized, high-affinity monoclonal and polyclonal antibodies to pharmaceutical and biotechnology companies as well as to academic, government, and nonprofit research institutions for use in discovery, research, and testing of novel pharmaceuticals, biomarkers, and diagnostic tests. The company’s products and services are based on a proprietary antibody discovery and development platform technology that enables rapid development of target-specific, high-affinity antibodies. Precision Antibody™ provides one-stop service for antibody development, characterization (affinity determination by Biacore analysis), purification/production (from pilot to large scale), and conjugation, as well as stable cell line development and hybridoma cell banking. Precision Antibody™ is a wholly owned service division of A&G Pharmaceutical, Inc. (www.agpharma.com) and is based in Columbia, MD.
Biacore™ is a registered trademark of GE Healthcare. Precision Antibody is not affiliated with GE Healthcare products or services.