Antibody Drug Evaluation & Testing
Antigen characterisation, antibody pair screening, assay optimisation, component production and performance validation — delivered as a ready-to-use kit.
We develop custom ELISA kits end to end. Starting from the target protein (antigen) or specific antibodies you provide, the work covers antigen characterisation, antibody pair screening, assay optimisation, standard preparation, production of every reagent component, performance validation and QC.
The result is a ready-to-use kit with stable performance and dependable data, suited to research, clinical biomarker detection, biologics quality control and quantitative analysis in drug development.
One platform spans upstream immunisation and antibody screening through downstream kit process development and production, with a deep antibody library and a proven expression and purification platform supplying quality raw material for pairing.
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A complete platform and track record from upstream immunization and antibody screening to downstream kit process development and manufacture.
An extensive antibody library and a mature protein expression and purification platform supply high-quality material for pair screening, backed by experience optimising HRP, ALP and other labelling and amplification systems.
Strict in-process and final-product QC is built into development, giving kits high sensitivity, a wide linear range and excellent precision and specificity.
The team has developed kits for rare targets across serum, plasma, cell supernatant and tissue lysate, and is equipped for complex challenges.
Five stages, built on the target protein (antigen) or specific antibodies you provide — SanjingBio can also raise antibodies or express and purify antigen alongside if needed. Outputs and acceptance criteria are in the specifications below.
Antigen and antibody quality are assessed, the format chosen (sandwich or competitive) and the plan set
Capture and detection antibodies are screened and paired, selecting high-signal, low-background combinations
Coating and antibody concentrations, blocking, incubation time and temperature are optimised
Sensitivity, range, precision, recovery, specificity and sample compatibility are validated systematically
Filled and assembled to the optimised process with final QC, delivered with the instructions and QC report
Suited to research, clinical biomarker detection, biologics quality control and quantitative analysis in drug development, with serum, plasma, cell supernatant and tissue lysate all supported.
One platform spans upstream immunisation and antibody screening through downstream kit process development and production. A deep antibody library and proven expression and purification platform supply the raw material for pairing, with experience across HRP, ALP and other labelling and amplification systems — including kits for rare targets and varied sample types.
Deliverables, acceptance criteria and timelines by experimental stage (source omits the time unit). The staging differs from the process above: the process shows how a project runs, while this table is the acceptance basis written into the contract.
| Stage | Scope | Deliverables | Standards | Timeline |
|---|---|---|---|---|
| Kick-off & design | Supplied antigen and antibody quality is assessed, the assay format chosen (sandwich, competitive and so on) and a detailed development plan drawn up. | Detailed development plan | The plan is sound and workable, with objectives confirmed by both sides. | 3-5 |
| Core material preparation & pairing | Antibodies are raised or antigen expressed and purified where required, then capture and detection antibodies screened and validated as pairs. | Pairing validation report with preliminary sensitivity and specificity data | At least one preferred pair with high signal and low background is identified. | 15-30 |
| Assay & process optimisation | Coating concentration, antibody concentration, blocking conditions, incubation time and reaction temperature are optimised. | Process parameter report and the optimised operating procedure | Optimal conditions are set for every step, with the standard curve fitting well (R² > 0.99). | 10-20 |
| Kit assembly & performance validation | Sensitivity, detection range, intra- and inter-plate precision, recovery, specificity (cross-reactivity) and sample compatibility are validated systematically. | Full performance validation report | Key performance indicators — detection limit, linear range, precision — meet the agreed criteria. | 10-15 |
| QC documentation & delivery | Filling, assembly and lyophilisation (where required) follow the optimised process, with final QC completed and standards and controls prepared | Ready-to-use kit with all components, instructions for use and QC report | Appearance, net content and performance match the validation stage and meet release criteria. | 5-10 |
Share the intended application and what you already have in hand. A scientist — not a sales rep — will scope feasibility, suggest the right route and send a quote, usually within one business day.
