Support Services for COVID-19 Diagnostics and Therapeutics

In the recent outbreak of COVID-19, there is an immediate need for specific, high-throughput and sensitive diagnostic assays. However, there are few CDC approved assays [1] available but their sensitivity might not be well accepted. A recent study [2] published in the Journal of Radiology showed CT being more sensitive than RT-qPCR based assay. Absorption Systems can help in developing PCR-based assays using state of the art technology like digital droplet PCR, which is known for its sensitivity over qPCR.

While the research to develop antibody-based assays is underway, we have several capabilities that can be utilized for supporting COVID-19 testing and vaccine development. These include development, qualification, and validation of various ELISA formats for detecting and quantifying biologics in various matrices, detection of viral shedding and copy number using RT-PCR as well as FACS and high-content imaging capabilities for looking at cellular markers associated with the viral infection. All these capabilities can be conducted in compliance with GLP and cGMP guidelines.

We also offer services in support of anti-viral drug development, including animal pharmacokinetic studies. We have the QA and IT support infrastructure to conduct these studies in compliance with current FDA and EMA standards.

  • Antiviral drugs
    • In Vitro Dissolution Absorption System (IDAS)
    • Transporter studies
    • In vivo PK studies including bioanalysis
    • Preclinical toxicology studies
    • Bioanalysis (LC-MS/MS) to support clinical studies (MD/MV/SA)
  • Anti-Covid-19 antibodies
    • In vivo PK studies including bioanalysis
    • Preclinical toxicology studies
    • PK, ADA, and Nab bioanalytical methods (MD/MV/SA)
    • Biomarkers (PD assays)
  • Vaccines
    • Viral shedding by PCR or ddPCR
    • Immune response evaluation by Flow Cytometry, ELISPOT, Nab assays, and biomarkers
    • Pre-clinical in vivo studies

References

  1. Website link: https://www.cdc.gov/coronavirus/2019-ncov/lab/index.html
  2. Correlation of Chest CT and RT-PCR Testing in Coronavirus Disease 2019 (COVID-19) in China: A Report of 1014 Cases, Ai, et al., Radiology, 2020.

Let’s talk about your COVID-19 program and how we can help