ANTIVIRAL THERAPY ASSAYS Customized Antiviral Drug Screening Assays/Tests

Marin Biologic Laboratories (“Marin Bio”) offers customized R&D, pre-clinical and clinical assay services for antiviral drug development.

Antiviral therapy consists of one or more methods for treating viral infections. The antiviral drugs are used for preventing or inhibiting the Attachment of viruses to target cell membranes (receptors), internalization of virus, fusion and uncoating of virus, viral DNA/RNA replication, viral protein synthesis, assembly and budding of virus, and virus release (Fig. 1). MarinBio Antiviral Therapy platform is developed based on our 27 years of experience in serving our clients through dedication, creativity, and innovations in the customizable services we offer. Through our Antiviral Therapy platform, we offer customizable services starting from project conceptualization through IND/NDA/BLA application and post-approval tests.

Fig. 1: Antiviral drug targets of RNA viruses.

 

Antiviral Discovery, Pre-Clinical and GMP Assays We Offer:

Molecular biology, Proteins, & In vitro assays

  • Cloning, expression & purification of viral proteins
  • qPCR
  • Protein functional assays
  • Receptor binding assays
  • Protease assays

Immunoassays

  • ELISA
  • Neutralizing antibody bioassays
  • Pharmacokinetics (PK) assays

Cell-based assays

  • Flow cytometry
  • ADCC, Antibody-Dependent Cellular Cytotoxicity bioassays
  • CDC or CMC, Complement-Dependent Cytotoxicity or Complement Mediated Cytotoxicity bioassays
  • CTL, Cytotoxic T-Lymphocyte killing bioassays
  • Flow Cytometry bioassays for proliferation and surface marker differentiation
  • MLR, Mixed Lymphocyte Reaction bioassays
  • ADA, Anti-Drug Antibody inhibiting drug action
  • Monocyte/macrophage and granulocyte activation bioassays
  • Oxidative Stress and Nitrosative Stress bioassays
  • Protease assays (cell-based)
  • Virus/pseudovirus neutralization assays.
  • Tissue culture infectious dose (TCID50) assay
  • 50% effective concentration (EC50) for cytotoxicity or other end points
  • Reporter assays
  • Development of customized reporter assays
  • Apoptosis assays
  • T cell activation assays
  • Dendritic cell (DC) assays
  • Cell proliferation assays
  • Antibody-dependent cellular cytotoxicity assays (ADCC)
  • Anti-drug antibody assay (ADA)
  • Complement-dependent cytotoxicity assays
  • MHC-I up-regulation assays
  • Lymphocyte proliferation assays
  • Cell cycle analysis assays
  • Cytotoxicity assays

Immunogenicity assays

  • Anti-drug antibody (ADA) assay
  • Neutralizing antibody (Nab) assay
  • ADCC, Antibody-Dependent Cellular Cytotoxicity
    bioassays
  • T-cell assays: Peripheral blood mononuclear cell (PBMand dendritic cell (DC)- based assays.
  • Cytokine Release Syndrome Assay
  • Natural Killer (NK) Cell Assay
  • Phagocytosis Assay

Custom assay development

  • We develop innovative project-specific assays/methods from idea to IND/NDA/BLA/stability/lot release. Our clients own the technologies we develop for them

Custom stable cell line development

Master cell bank

Drug lot release assays/tests- Potency assays

The MarinBio supporting technology for these areas are:

Case Study: GMP flow cytometry assay to determine neutralization activity of recombinant antibody against SARS-CoV-2 reporter viral particles.

This assay was performed following Marin Biologic Laboratories (MBL) SOP for SARS-CoV-2 reporter viral particle neutralization assay.

Fig. 1: SARS-CoV-2 GFP viral particle neutralization assay by flow cytometry. Live cells are gated and analyzed for reporter gene presence (right side of charts). Increasing antibody concentrations show effective inhibition of SARS-CoV-2 reporter virus neutralization.

 

Fig. 2: SARS-CoV-2 GFP viral particle neutralization assay. The test sample was analyzed with the Reference Standard with GFP as the reporter gene. Relative potency is calculated for stability studies.

 

“Parts of the figure were drawn by using pictures from Servier Medical Art. Servier Medical Art by Servier is licensed under a Creative Commons Attribution 3.0 Unported License (https://creativecommons.org/licenses/by/3.0/).”

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