MARINBIO: Excellence in Cell-Based Assays & Biology Assays, Successfully Passes FDA Audit for Commercial Pharmaceuticals | LEARN MORE

Unlock the full potential of your drug discovery process with MarinBio’s Cell-Based Assays Services. With over 28 years of expertise, we deliver highly specialized cellular assays crucial for evaluating drug effects, DNA/RNA interactions, and more. Let us accelerate your path from research to market—discover unparalleled accuracy, innovation, and regulatory support.

Cell-Based Assays measure the quantitative and qualitative effects of drugs in a biological system.  Our cell-based assays are strategically designed based on factors such as mimetic of disease states, stimulation/proliferation, and or inhibition/cytotoxicity. MarinBio will assist you in your discovery and potency development through IND/BLA applications, maintenance during commercialization  as well as PK studies.

With over 28 years of experience, MarinBio’s GMP bioassay and GMP cellular assay development 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

We will customize cell-based bioassay for  your project, or transfer in your established assays.

 

Dose-response curve for drug-induced cell proliferation measured in a MarinBio cell-based assay
Quantifying Drug Efficacy with MarinBio’s Cell Proliferation Assay

 

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Leading-Edge Cell-Based Assays for Gene Therapy Development

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

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.

Clinical studies, pre-clinical studies, sample analyses, examples:

ADCC, antibody-dependent cellular cytotoxicity bioassays

CDC, complement-dependent cytotoxicity bioassays

CTL, cytotoxic T lymphocyte killing bioassays

ADA, anti-drug antibody inhibiting drug effectiveness (AKA neutralization) bioassays

Flow cytometry assays (protein expression, cytokine production, cell identity, population studies, multiplex assays etc.)

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 subcellular fractionation and localization bioassays

Drug target pathway and phosphorylation bioassays

Mechanism of action bioassays

Receptor, protein binding, and turnover bioassays

Reporter bioassays

Exosome bioassays

Metabolic bioassays

Migration and wound healing bioassays

MarinBio’s Art & Science of Cell Culture

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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