PPD Expands Laboratory Test Portfolio for COVID-19 Therapy and Vaccine Development Programs

PPD, Inc. has expanded its laboratory test portfolio by adding five new molecular, serology and functional assays designed expressly for COVID-19 vaccine and therapy development programs. These assays have been developed by PPD^® Laboratories’ bioanalytical, biomarker and vaccines sciences labs to run on multiple assay platforms and are compatible with high-throughput liquid handling so they can support large numbers of specimens, attributes that will be critical to the success of COVID-19 trials.

“PPD Laboratories is fully committed to helping our customers bring COVID-19 vaccines and therapies to fruition,” said Christopher Fikry, M.D., executive vice president of PPD Laboratories. “The addition of these five assays to our test portfolio will enable us to expand our support of many important COVID-19 trials. We’ve also incorporated innovative measures so trials can start more quickly, run more efficiently and conclude sooner.”

PPD’s new molecular assays utilize reverse transcriptase, polymerase chain reaction (RT-PCR), a versatile analysis technique that can aid in the diagnosis of disease and give a measure of gene expression, making it a valuable tool for viral infection studies. Specifically, these assays will detect SARS-CoV-2, the causative agent of COVID-19, and quantify the number of infectious particles to determine viral load. These assays target spike proteins that are specific to SARS-CoV-2 and nucleocapsid proteins that are more general to the coronavirus family. The qualitative (RT-PCR) assay targets both spike and nucleocapsid proteins within open read frame 1 (ORF-1). This assay uses MS2 bacteriophage as a monitor for ribonucleic acid (RNA) purification. The quantitative RT-PCR assay (RT-qPCR) solely targets nucleocapsid proteins and utilizes human ribonuclease P (RNase P) targets as a purification control.

Two enzyme-linked immunosorbent assays (ELISA) have been developed specifically for vaccine trials to detect immunoglobulin G to full-length recombinant protein, one for spike and the other for nucleocapsid. These assays can be used to include or exclude subjects from vaccine trials or to monitor antibody production after vaccination. They are supported by proprietary bioinformatics tools that analyze complex data sets from these high-throughput assays.

PPD Laboratories also has developed a plate-based functional assay to detect anti-spike antibodies in human serum that can prevent infection by disrupting the binding of angiotensin converting enzyme 2 (ACE2) to SARS-CoV-2 spike protein. The ACE2 binding inhibition assay can be used in COVID-19 therapy trials to detect antibodies that may be essential to neutralizing the virus and preventing infection. The PPD Laboratories central lab also is validating molecular and serology in vitro diagnostic assays that are released for commercial use by regulatory agencies to support clinical trials. PPD’s central lab locations allow the company to perform these tests globally.

PPD Laboratories’ test portfolio includes more than 1,500 assays, along with a variety of drug characterization methods and bioanalytical analysis tools. PPD has broad experience across viral and bacterial agents, as well as extensive expertise with multiplexed functional assays and more than 25 years of vaccine efficacy and immunogenicity experience. PPD Laboratories has supported 15 vaccine programs approved by the U.S. Food and Drug Administration and has experience with more than 25 therapeutic agents that are currently being assessed for use against COVID-19.