Antibody Production
Antibodies that bind the idiotopes in a drug antibody's variable region — the key reagents for pharmacokinetic (PK) and immunogenicity (ADA) analysis.
The idiotype is the antigen-specific signature unique to each antibody molecule, and its epitopes are called idiotopes. An anti-idiotypic antibody (AId) is one that binds specifically to the idiotopes in the variable region of the antibody under test.
It detects the drug antibody in vivo specifically, making it the key reagent for pharmacokinetic studies during antibody drug development. Beyond that it serves immunogenicity analysis, vaccine development, ligand neutralisation and antibody blocking assays, and extends into transplant immunology, autoimmune disease and tumour immunology.
SanjingBio designs custom anti-idiotypic antibody programmes for pharmacokinetic (PK) and immunogenicity (ADA) analysis of antibody drugs. Several strategies are available for the hard problems that arise in this work, and the service runs from antigen preparation and antibody development through assay establishment and kit development.
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Rational design plus efficient screening pinpoints the idiotypic epitope and markedly raises success rates.
More than 15 years of anti-idiotypic antibody experience to handle the challenges that arise in development.
Complete kit development with sensitivity that meets demanding preclinical and in vitro diagnostic requirements.
Immunization design, antibody screening, process development and production in one workflow to keep projects moving.
Six stages. You may supply the full-length antibody — SanjingBio digests and purifies it into the Fc-free drug fragment as immunogen; the monoclonal route moves into library construction and screening once titre is reached.
Supplied or commissioned; full-length antibody digested and purified into the Fc-free fragment
Standard immunization protocol over 8–10 weeks
Antiserum ELISA titre testing, titre ≥1:256,000
Hybridoma / single B cell / phage display, delivering sequences of 5–10 positive clones
Protein A / antigen-affinity purification or Expi293 expression, purity ≥95%
SDS-PAGE/UV/ELISA/WB testing with the certificate of analysis (CoA) delivered
Polyclonal route: 8–10 weeks immunization plus 3 days each for titre, purification and QC. Monoclonal route: 4–8 weeks library and screening plus 1–2 weeks production, with one competitive or non-competitive clone guaranteed.
Anti-idiotypic antibodies specifically detect the drug antibody in vivo — the key reagent for pharmacokinetics — and also serve immunogenicity analysis, vaccine development, ligand neutralisation and blocking assays. SanjingBio covers the full chain from antigen preparation and antibody development to assay establishment and kit development.
Deliverables, acceptance criteria and timelines for both the polyclonal and monoclonal services.
| Stage | Scope | Deliverables | Standards | Timeline |
|---|---|---|---|---|
| Anti-idiotypic polyclonal antibody service | ||||
| Antigen preparation | Supplied by you or prepared by SanjingBio; you may provide the full-length antibody and we will digest and purify it to obtain the Fc-free drug fragment | Peptide / protein | Peptide purity >95%, protein purity >85% | 3–5 weeks |
| Animal immunization | Standard immunization protocol | Pre-immune serum; 10–20 mL antiserum | / | 8–10 weeks |
| Titre testing | Antiserum ELISA titre testing | Titre report | Titre ≥1:256,000 | 3 days |
| Antibody purification | Protein A antigen affinity purification | ≥10 mg, or 1–2 mg purified antibody | Purity ≥95% | 3 days |
| QC testing | SDS-PAGE / UV / ELISA / WB | Certificate of analysis (CoA) | Cross-reactivity of the purified antibody with total IgG <2% | 3 days |
| Anti-idiotypic monoclonal antibody service | ||||
| Antigen preparation | Supplied by you or prepared by SanjingBio; you may provide the full-length antibody and we will digest and purify it to obtain the Fc-free drug fragment | Peptide / protein | Peptide purity >95%, protein purity >85% | 3–5 weeks |
| Animal immunization | Standard immunization protocol | Pre-immune serum; 10–20 mL antiserum | / | 8–10 weeks |
| Titre testing | Antiserum ELISA titre testing | Titre report | Titre ≥1:256,000 | 3 days |
| Library construction & screening | Hybridoma / single B cell / phage display | Positive clones | ELISA-positive, WB-positive | 4-8 weeks |
| Antibody production & purification | Expi293 expression and purification | ≥1 mg purified antibody per clone | Purity ≥95% | 1–2 weeks |
| QC testing | SDS-PAGE | Certificate of analysis (CoA) | Sequences of 5–10 positive clones (with at least one competitive or non-competitive antibody guaranteed); 1 mg antibody purified from one selected clone | 3 days |
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.
