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Cell Based Assay Services for Cytotoxicity, Potency, Bioactivity by PhD Scientists at 20+ Year, FDA-Inspected Lab

De-Risk Your Cell Based Assay, Discovery to GxP/CMC-Ready.

Brief PhDs on your bioassay, cells and study.
  • Cell-based assays for cytotoxicity, cell killing, apoptosis, ATP viability, MTT proliferation and cell signaling
  • Cellular assays for screening, potency, bioactivity, MOA and immunogenicity, using licensed or commercial supplies
  • Bioassays for small molecules, biologics and CGT on cell lines, primary, tumor, organoid and 3D culture
  • Discovery to GxP validation, lot release and CLIA testing, with reporter gene, luciferase, flow and imaging readouts

Regulated And Inspected By:

  • Good Laboratory Practice for Nonclinical Laboratory Studies | NorthEast BioLab
  • Food and Drug Administration (FDA | NorthEast BioLab
  • College Of American Pathologists | NorthEast BioLab
  • International Orgaization for Standardization | NorthEast BioLab

The PhD Scientists Behind Your Cell-Based Assays

20+ Years In Bioanalysis
700+ Sponsor Studies
500+ Custom Assays
200+ Investigational Drugs

Engineered Cell-Based Assays and Bioassays for Hard-to-Model Biology

When a potency assay cannot pass validation, a finished lot cannot ship. So we build for the assay window, parallelism and stability that release demands, on a biologically relevant model for your therapeutic, from discovery through GxP and CLIA.

Assay Development & Cell Model Selection

  • Tumor and primary lines, iPSC and organoids, or we build a custom reporter line expressing your target.
  • Built for the FDA push away from animal testing, then qualified for signal window and robustness.

Cell-Based Immunogenicity (NAb) Testing

  • Cell-based neutralizing antibody assays measuring inhibition of biological activity for mAbs and CGT.
  • Read out by proliferation, cytotoxicity, reporter gene or flow cytometry, matched to your mechanism.

Discovery Screening & Lead Optimization

  • Phenotypic and target-based screening, plus migration, invasion and morphology by imaging or flow.
  • Viability and permeability endpoints at throughput, with deeper transporter work on our DMPK page.

Potency & Relative Potency for Release

  • Reporter-gene and luciferase relative potency for biologics, peptides, growth factors and CGT.
  • Relative potency with parallelism, the format regulators expect for comparability and for lot release.

Mechanism of Action & Target Engagement

  • Target affinity, penetration and pathway activity by BRET, FRET, HTRF, AlphaLISA and polarization.
  • Kinase and enzymatic activity, cell signaling, gene silencing and RNAi to establish the mechanism.

GxP Validation & Lot Release Testing

  • Tech transfer and GxP validation of cell-based potency methods in 4 to 6 weeks, plus CMC docs.
  • Cell banking and assay stability across the product lifecycle, because a stable assay is cheaper.

In Vitro Safety & Toxicology Assays

  • Cytotoxicity, apoptosis and necrosis by ATP, MTT, membrane integrity and clonogenic survival assays.
  • Mitochondrial toxicity, immune-mediated killing and target-cell lysis for early liability reads.

CLIA Clinical Cell-Based Sample Testing

  • Method validation and patient-sample analysis under CLIA for clinical trial support and follow-up.
  • Cells destined for clinical use, tested under a regulated quality system with full traceability too.

From Discovery Through Lot Release: Cell-Based Assays for Small Molecule, Biologic, CGT

The potency and function questions we answer in cells. Where a service page owns the follow-on work, it is linked.

De-Risk Your Cell-Based Assay With PhD Scientists For Potency, MOA And In Vitro Toxicology, On Budget And On Time

Talk Science First? Book a Call With Our Bioassay Experts.

Discuss cell model, readout and feasibility.
  • Protect your cell-based assay from costly delays. Our PhDs catch donor variability, passage drift, and weak signal windows up front, so a flawed method does not stall your therapeutic.
  • Stretch your bioanalytical budget. Proven cell-based assay validation gets your method right the first time, so your spend goes to quality science, not to fixing avoidable mistakes.
  • Hit your timeline. A focused cell-based study runs two to four weeks from signature to results, and the scientist plating your cells is reachable directly rather than through an account team.

20+Years Of Cell Culture And Bioassay Work, Since 2003

500+Custom Methods, Including Cell-Based And Plate-Based

Control Cost, Hit Timeline

Any scope change goes through a pre-approved SOW addendum, so your cost cannot move without an SOW addendum you have already approved. You get a transparent, itemized quote up front, scoped to your cell system, readout and plate count rather than priced off a flat rate. Cell-based assay development typically runs two to four weeks, with validation in four to six, and your audited report with full validation detail follows about two weeks after that. You can opt for rolling data and act on results before the report lands. Cell banks, donor lots and passage numbers are controlled and documented from the first plate, and we work to current FDA and ICH guidance unless your program says otherwise.

Fast Quote, Quality Work

Three things get you a quote: your readout and endpoint, proliferation, viability, cytotoxicity, reporter or potency, your cell system, an established line or primary donor cells, and the validation rigor you need, fit-for-purpose or GxP. If you already have a protocol, a cell bank, or prior run data, send what you have and we will scope against it. Just starting out, lean on us, because our assay development experience fills in the blanks. We build and bank custom reporter lines in-house, so a construct you do not have yet is not a reason to wait. You get an itemized quote and a timeline back, scoped against exactly what you sent us.

Sponsors On Our Cell-Based Scientists And What They Deliver

  • VP, Clinical Stage Biotech

    The ability to work with our timelines to meet deadlines is very much appreciated.

  • CRO Partner

    Really appreciate the Co-Presidents’ hands-on approach.

  • Sr. Associate Dir., Clinical Trials

    We have worked with NorthEast BioLab for over ten years given their commitment to highest quality bioanalytical data.

  • Head, PK

    This study, same as all other bioanalytical studies, was completed with top quality and reporting standard with incredible responsiveness.

  • Director, Clinical Stage Biotech

    The expertise, competence and responsiveness demonstrated in setting up our clinical trial and preparing and shipping sample kits to the clinical site have been excellent.

  • Executive, Clinical Stage Biotech

    There was an issue with half-life extrapolation, and NorthEast BioLab brought in the right experts to find the solution.

Need a Bioassay Designed? Potency, MOA or Cytotoxicity.

Share the mechanism. We'll pick the cell model.

Why Biotechs Bring Us The Potency Assay That Has To Survive Review

20+ years of cell-based work on biologics, cell therapy and small molecule programs.

Expert Cell-Based And Potency Assay Development

  • Custom reporter line creation and banking in-house, so your potency assay is not hostage to a vendor.
  • Signal window, donor lot and passage range fixed up front, because a drifting cell system fails late.
  • Senior scientists here carry 18+ years in the industry, and they stay, which is why the same people are on your study next year.

Responsive Cell Culture CRO, Flexible Lab Service

  • Flexible plate formats and staged data releases when your compound list or your priorities shift.
  • Direct access to the senior scientist on your assay, on culture conditions and every readout call.
  • Fit-for-purpose or full GxP rigor, matched to where your program actually sits right now.
Anti-Drug Antibody (ADA) Assays Development, Immunogenicity Assessment | NorthEast BioLab

Neutralizing Antibody Assay, NAb Assay Service, NAb Analysis

Understand Plate, Cell Based Neutralizing Antibody Assay Development And Validation, NAb Assay Techniques, Cell Based NAb Assays, Neutralizing Antibody Titers …

From Your Cell System To An Audited Report: How A Study Runs Here

  1. 1. Feasibility

    We confirm your readout gives a usable signal window in the cell system your study needs.

  2. 2. Quote And SOW

    Itemized scope, cell system and reagent sourcing settled, timeline agreed before work starts.

  3. 3. Method Development

    Culture conditions, seeding density, incubation and readout optimized, reporter line built if needed.

  4. 4. Validation

    Two to four weeks to develop, four to six to validate, fit-for-purpose or full GxP.

  5. 5. Sample Analysis

    Treated and control arms plated together, with replicates and plate controls per run.

  6. 6. Audited Report

    Curves, potency values and the plate-level raw data, about two weeks after the last run.

Why Sponsors Choose Our Cell-Based Assay Lab For Potency That Is Reviewed

Get Your Bioassay Design Reviewed By PhD Scientists.

Send your plan. We'll flag pitfalls before they cost you.
  • The scientist plating your cells knows your compound by name and picks up the phone.
  • We build and bank your reporter line in-house, so your potency assay does not depend on a vendor’s stock.
  • We fix donor lot and passage range up front, because a drifting cell system fails at the worst time.
  • No study or pilot is too small. A single plate feasibility gets the same scientists.

Regulated And Inspected By:

  • Good Laboratory Practice for Nonclinical Laboratory Studies | NorthEast BioLab
  • Food and Drug Administration (FDA | NorthEast BioLab
  • College Of American Pathologists | NorthEast BioLab
  • Clinical Laboratory Improvement Amendments | NorthEast BioLab
  • International Orgaization for Standardization | NorthEast BioLab
  • United States Drug Enforcement Administration | NorthEast BioLab

One Team On Your Molecule, From First Plate To Reviewed Potency Data

A potency assay is finished when somebody outside your company accepts the number. Standard, criteria and suitability are fixed before samples arrive.

Related FAQs

Answers to additional Cell-Based Assay questions popular among our potential sponsors.

What are Cell-based Assays?

What is the Role of Cell-based Assays during Drug Development?

What does a potency assay for lot release require?

Do you build custom reporter or stable cell lines?

When does a program need a cell-based NAb assay instead of a ligand-binding one?

Can the same lab run our discovery screen and our release assay?

What are the different types of cell based assays?

What are the different types of assays in cell culture?

What are cell proliferation assays used for?

What is an assay for cell viability?

What are cell based screening assays, and how do they differ from other screening methods?