US-based contract research organisation (CRO) PPD is launching a centre of excellence for vaccines and biologics.
Building on the CRO’s collaborative relationship with Merck & Co for vaccine testing and assay development, the PPD Vaccines & Biologics Center of Excellence offers a “first-in-kind” network of comprehensive laboratory services for vaccines, monoclonal antibodies, peptides, protein-drug conjugates and other biologics, with state-of-the-art facilities, processes and instrumentation, the company says.
Integrating vaccine testing with bioanalytical, current Good Manufacturing Practice (cGMP) and global central laboratory services will give biopharmaceutical companies the opportunity to streamline and customise laboratory services for their biologics portfolios, PPD added.
“With the industry’s largest collection of commercial vaccine assays and strong immunochemistry, cell culture and cGMP lab operations, PPD is the first CRO to offer the type of laboratory support that has the potential to bring significant efficiencies to the development of vaccines and biologics,” commented chief medical officer Dr Christine Dingivan.
The CRO has developed new technologies and assays to expand its vaccine testing services into the oncology category, as well as the “unique” capability to provide comprehensive concurrent-use testing for investigational paediatric and adolescent vaccine programmes, it noted.
Concurrent use testing of new vaccines is a regulatory requirement designed to ensure that vaccines under development do not interfere with the efficacy of marketed vaccines co-administered to the same patient population.
Biologics and vaccines markets are among the fastest growing segments of the biopharmaceutical market, PPD pointed out. According to EvaluatePharma, the compound annual growth rate of biologics is projected at 8.5% from 2008 to 2014, eight to 10 times greater than the growth rate for small-molecule drugs.
In January 2009, PPD acquired a 130,000 sq ft vaccine testing laboratory and related equipment in Wayne, Pennsylvania as part of a collaborative agreement with Merck & Co. The deal involved the CRO hiring the Merck employees who operated the US facility and providing the company with assay development and immunogenicity testing services to support its vaccine portfolio over a five-year period.
PPD also agreed significantly to expand its existing central laboratory service relationship with Merck, supplying traditional central laboratory and sample storage services to back up the company’s clinical development activities over five years.
