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.
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.
The potency and function questions we answer in cells. Where a service page owns the follow-on work, it is linked.
ADCC and CDC reporter bioassays
Read moreAntigen positive and negative lines, IC50, co-culture
Read moreTDCC, target lysis, T-cell activation
Read moreCo-culture killing, CD69, spheroid models
Permissive line, transgene expression
Read moreSerum inhibition of pseudovirus entry
Read moreHigh-volume IC50 across compound sets
Whole blood or PBMC stimulation
Read more20+Years Of Cell Culture And Bioassay Work, Since 2003
500+Custom Methods, Including Cell-Based And Plate-Based
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.
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.
The ability to work with our timelines to meet deadlines is very much appreciated.
Really appreciate the Co-Presidents’ hands-on approach.
We have worked with NorthEast BioLab for over ten years given their commitment to highest quality bioanalytical data.
This study, same as all other bioanalytical studies, was completed with top quality and reporting standard with incredible responsiveness.
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.
There was an issue with half-life extrapolation, and NorthEast BioLab brought in the right experts to find the solution.
20+ years of cell-based work on biologics, cell therapy and small molecule programs.
Understand Plate, Cell Based Neutralizing Antibody Assay Development And Validation, NAb Assay Techniques, Cell Based NAb Assays, Neutralizing Antibody Titers …
We confirm your readout gives a usable signal window in the cell system your study needs.
Itemized scope, cell system and reagent sourcing settled, timeline agreed before work starts.
Culture conditions, seeding density, incubation and readout optimized, reporter line built if needed.
Two to four weeks to develop, four to six to validate, fit-for-purpose or full GxP.
Treated and control arms plated together, with replicates and plate controls per run.
Curves, potency values and the plate-level raw data, about two weeks after the last run.
A potency assay is finished when somebody outside your company accepts the number. Standard, criteria and suitability are fixed before samples arrive.
Answers to additional Cell-Based Assay questions popular among our potential sponsors.