CELL-BASED ASSAYS

Cell based assays measure quantitative effects of drugs, DNA/RNA/protein/small molecules/nanoparticles. The assay is designed based upon the disease states, proliferation, cytotoxicity, signaling pathways, gene expression, amongst other endpoints. MarinBio is set to assist you in your discovery, potency development through IND/BLS applications as well as PK studies.

MarinBio’s deep bioassay expertise includes:

  • Bioassays with primary cells or secondary immortalized/transformed cell lines
  • Commercially available immortalized/transformed cell lines (cell line clones)
  • Customized transfected cell lines (clones/sub-clones) to meet client requirements

Whether a client has already established a cell-based assay for transfer to MarinBio or is seeking to newly develop a customized bioassay, the bioassay expertise we have accumulated over 25 years of experience enables highly efficient, rapid, and cost-effective routes to the successful development, qualification, and/or validation of the cell-based assays you need. MarinBio also performs bioassays for lot release.

We are experts in the art and science of cell culture. Scroll down for more information on some of the different assays MarinBio has successfully designed and executed in client contracts.

Cell Morphology Changes With Drug Treatment

SHSY5Y cells are differentiated into neural cells after seven days’ treatment with retinoic acid. The cells were treated with or without client drug for one additional day. Left Panel: control (no drug); Right Panel: with client drug. The observed morphological changes were a result of the drug treatment.

Drug Concentration Induces Cell Proliferation

CTLL-2 cells were cultured with increasing concentrations of client drug for four days. Cell proliferation was measured with CellTiter-Glo (Promega, Wisconsin, USA). Application of the client drug led to cell proliferation with the two standards showing precise and identical results.

 

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MARINBIO’S BIOASSAY SERVICES FOR IN VITRO LIVE CELL INTERACTIONS WITH DRUGS

Cell-based assays (bioassays) measure functional effects of drugs to establish their biological relevance and physiological importance. MarinBio’s contract research and development service professionals are expert in designing customized or standardized bioassays and in the measurements of interactions of drugs (including small molecules, biologics, or device interactions) with cultured cells and primary cells. MarinBio’s Ph.D. scientists have successfully interfaced with the FDA on behalf of our clients, when requested.

Additionally, MarinBio specializes in in vitro cell-based assay testing services for clinical and pre-clinical studies, including method development, qualification, validation, transfer, lot-release testing, and potency testing according to guidelines from both FDA and International Council for Harmonization (ICH). MarinBio has extensive experience with cells and cell banks at both non-GMP/‑GLP and GMP/GLP levels of many tissue cell types and clones, in addition to custom development of cells, clones, or sub-clones. Our expertise has enabled us to produce over 200 different bioassays for our clients during the past 25 years. Some of the assays we perform are listed below (click on highlighted terms to link to our Glossary):

Potency bioassays, lot-release bioassays
Clinical studies, pre-clinical studies, sample analyses
ADCC, antibody-dependent cellular cytotoxicity bioassays
CDC, complement-dependent cytotoxicity bioassays
CMC, complement-mediated cytotoxicity bioassays
CTL, cytotoxic T lymphocyte killing bioassays
ADA, anti-drug antibody inhibiting drug effectiveness (AKA neutralization) bioassays
Flow cytometry reporter and protein expression bioassays
Flow cytometry multiplex cytokine assays, flow high-throughput bioassays
MLR, mixed lymphocyte reaction bioassays
Cell enzyme bioassays
Cell proliferation bioassays
Cell signaling at cell surfaces or intracellular signaling bioassays
Cell toxicity, apoptosis, and necrosis bioassays
Cell transfection and transient or stable gene transcription and protein expression bioassays
Agonist/antagonist bioassays
Drug combination bioassays
Drug delivery bioassays
Drug metabolism bioassays
Drug subcellular fractionation and localization bioassays
Drug target pathway and phosphorylation bioassays
Gene activation, expression modification by transfection bioassays
Mechanism of action bioassays
Receptor, protein binding, and turnover bioassays
Reporter bioassays
Exosome bioassays
Metabolic bioassays
Migration and wound healing bioassays

QUICK READS

From the beginning and ongoing, your assay is a critical component of the life cycle of your current or eventual product. That is precisely why you want experience and expertise at the earliest possible stage of your development.

When you require an assay to prove your science and there is no commercial kit available, you need a custom assay. MarinBio’s extensive expertise enables rapid and methodical development of your assay for eventual validation. Typically, a custom assay can be developed from the inception to a completed bioassay in 5 or less experiments, while minimizing any effects of the matrix.

MarinBio expert at preparing and validating GMP/GLP or research level cell banks. The banks could include primary cells or cell lines for specific bioassays, as well as cell bank uses for production, isolation and characterization of genetically defined clonal cell populations and small-scale manufacturing of biologic products.

MarinBio professionals have vast experience with improving cell culture growth, freezing, serum-free culture, cloning for client bioassays, as well as transfection with DNA or RNA and/or liposomes (lipofection) for genetically variant cell lines as well as for gene or protein expression bioassays.

Our scientists have developed over 200 custom bioassays involving growth, toxicity, transfection, cell surface, cytokine or gene expression. We are your scientists; MarinBio will make your GMP potency lot release assay or drug screening assay.

Many companies planning an IND submission or in Phase I/II may only require a well-qualified assay, rather than a fully validated assay. You may or may not need GLP/GMP stringency and auditability. The expert MarinBio scientific team works with your scientists to qualify your assay for reproducibility, appropriate precision and accuracy, with validation in mind for the future.

To validate an assay, the precision, linearity, accuracy, robustness, system suitability and repeatability is measured to meet acceptance criteria. We in-source your assay or fully develop and validate an assay to meet the FDA GLP or GMP requirements.

When patient samples or drug product samples need analysis, MarinBio will map out a timeline and follow through with sample receipts, meeting your regulatory needs at all points. We perform your assay as a developed, qualified or validated bioassay, and promptly communicate the results and/or provide a Certificate of Testing for any or all of your pre-clinical or clinical phases.

Knowing the importance to the FDA of lot release potency testing data, our professional scientific team tests every manufactured lot with your assay and provides Certificates of Testing.

In order to determine shelf-life for a particular drug substance, stability tests are performed at pre-determined calendar intervals. MarinBio’s expert project coordinators communicate closely with you to anticipate the arrival of samples in order to be prepared for timely analysis and the submittal of data and Certificates of Testing.

MARINBIO’S ART & SCIENCE OF CELL CULTURE

The complexity of successful cell-based assay and bioanalysis demands advanced bioassay skills, cell culture expertise and knowledge of the bioassay parameters, as well as the FDA regulatory standards. The MarinBio senior Ph.D. scientific staff averages 15-25 or more years of professional experience in designing and developing cell-based assays, as well as interfacing on behalf of our clients with the FDA, when requested. We have developed and perfected a comprehensive, rapid, cost effective approach for successful cell-based assays, including client customized bioassays that are technically demanding and intricate.

MarinBio’s Art & Science of Cell Culture

 

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