Antiviral Therapy Assays

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

Cell-based assays

  • ADCC, Antibody-Dependent Cellular 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 
  • granulocyte activation bioassays
  • Virus/pseudovirus neutralization assays.
  • Reporter assays
  • T cell activation assays
  • Cell proliferation, cell cytortoxicity assays
  • Anti-drug antibody assay (ADA)
  • Immunogenicity assays
  • Cytokine Release Syndrome Assay
  • Natural Killer (NK) Cell AssayPhagocytosis Assay
 

Molecular biology, Proteins, & In vitro assays

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

Immunoassays

  • ELISA
  • Pharmacokinetics (PK) assays

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

Stability testing

Lot release testing

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.

Flow cytometry results of SARS-CoV-2 neutralization assay with increasing antibody concentrations

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.

Graph showing relative potency of test sample vs reference standard in SARS-CoV-2 neutralization assay

Need Help or Have Questions on Antiviral Therapy Services?

Contact us to discuss the specifics of your project. Our team of experienced scientists is ready to assist you with tailored solutions to meet your unique needs. Whether you need help with assay development, FDA IND, stability study,  lot release approval, or other scientific endeavors, we are here to support you.
Contact us to learn more about our cell based assay services

We will initiate your project as soon as the proposal is approved and signed by you. Our streamlined process ensures a quick start, minimizing delays and maximizing efficiency. Fill out the form below to email us or click our live chat option to speak with a MarinBio Scientist and get your project underway.

Yes, we have over 30 years of expertise in developing and validating cell based assays for FDA IND, lot release or stability study approval. Our team can also liaise directly with the FDA on your behalf, ensuring a smooth and compliant process. Please contact us to learn more about how we can assist you with your assay development and FDA approval needs.

MarinBio scientists are experienced and creative in designing, developing, validating assays. Some of the assays we perform are listed below, but there are many more that we created, developed and validated. Give us call so that we may help you.

MarinBio scientists conducting targeted protein degradation assays in advanced laboratory

Need Help or Have Questions on Antiviral Therapy Services?

Give us a call at 415-883-8000

With 30 years of expertise in immunology, ELISA, cellular immunoassays, cell culture, and cell-based assays, we specialize in offering anti-viral therapy assay services that are essential for IND/BLA applications and commercialization. MarinBio anti-viral therapy platform is customized based upon our client’s needs.

Our comprehensive services include both non-GMP and GMP assays, providing critical support throughout the development pipeline. We offer:

  • Unmatched quality
  • Prompt timeliness
  • Cost-effective solutions
  • Exceptional communication

We maintain direct interactions with the FDA, both independently and through our clients.

Antiviral therapy workflow: from virus entry to drug inhibition points

Antiviral therapy consists of one or more methods for treating viral infections. DNA viruses infect cells through a series of steps: they attach to host cell receptors using viral proteins and enter the cell via endocytosis or membrane fusion. The viral capsid is then transported through the cytoplasm, often using the cell’s cytoskeleton, and undergoes uncoating to release the viral DNA genome. The viral genome typically enters the nucleus for replication, utilizing the host cell’s machinery. New viral genomes and proteins are assembled into new virus particles, which exit the cell through cell lysis or budding. RNA viruses infect cells by attaching to host cell receptors using viral proteins, entering the cell via endocytosis or membrane fusion. Inside the cell, the viral capsid breaks down, releasing the viral RNA genome into the cytoplasm. The viral RNA is translated by host ribosomes to produce viral proteins, which form replication complexes. The viral RNA-dependent RNA polymerase synthesizes complementary RNA, which serves as a template for producing more viral RNA genomes. Finally, new viral genomes and proteins are assembled into new virus particles, which exit the cell through cell lysis or budding.

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.

Contact Us About Our Antiviral Therapy Assays Services

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