White-label antibody production for diagnostic kit manufacturers and therapeutic developers. Consistent quality, scalable supply, and full regulatory documentation — under your brand.
OEM (Original Equipment Manufacturer) antibody manufacturing is a contract arrangement in which AntibodyLLM produces antibodies according to your specifications, which you then incorporate into your branded products — diagnostic kits, research reagents, or therapeutic formulations. You retain full IP ownership of the final product; AntibodyLLM provides the manufacturing platform, quality infrastructure, and regulatory documentation.
ODM (Original Design Manufacturer) services go a step further: AntibodyLLM not only produces the antibody but also participates in the design and selection process — identifying antibody candidates, optimizing for your specific assay format, and delivering a validated, ready-to-use component for your product.
For IVD diagnostic companies, antibody supply chain reliability is a critical business risk. A single supplier disruption can halt kit production. AntibodyLLM's stable CHO cell line development platform ensures lot-to-lot consistency from a banked master cell line, protecting your supply chain from the variability and obsolescence risk of hybridoma-based suppliers.
Produce your existing antibody (provide sequence or hybridoma) at any scale. Delivered in your specified buffer, concentration, and packaging format. CoA and product documentation carry your brand.
AI-guided selection of capture/detection antibody pairs for sandwich ELISA, lateral flow, CLIA, or FEIA platforms. Optimized for sensitivity, specificity, and cross-reactivity rejection.
HRP, biotin, FITC, PE, APC, gold nanoparticle, and NHS ester conjugation. Site-specific conjugation using engineered cysteine or non-natural amino acid insertion for homogeneous labeling.
IND-enabling and clinical trial material with full GMP documentation: batch records, CoA, HCP/DNA testing, sterility, and regulatory files for NMPA, FDA, or EMA submissions.
AntibodyLLM is a specialized partner for in vitro diagnostic (IVD) antibody manufacturing. IVD applications demand antibodies with specific properties that differ from therapeutic applications: high sensitivity in complex biological matrices (serum, urine, saliva), precise epitope targeting for cross-reactivity rejection, and stability under dry storage conditions for lateral flow strips.
Rapid antigen tests: SARS-CoV-2, influenza A/B, RSV, HIV, hepatitis, malaria, dengue. AI-optimized for high sensitivity at low antigen concentrations.
AFP, CEA, PSA, CA125, CA19-9, HER2 capture/detection pairs for oncology diagnostics. Chemiluminescence and electrochemiluminescence-compatible.
Troponin I/T, BNP, NT-proBNP, HbA1c, insulin, thyroid panel (TSH, FT3, FT4) antibody pairs for POCT and central lab platforms.
Therapeutic drug monitoring (TDM) antibodies for cyclosporin, tacrolimus, anti-TNF biologics, checkpoint inhibitor monitoring.
Anti-IgE, anti-IgG4, cytokine (IL-6, TNF-α, IFN-γ) detection antibodies for allergy and autoimmune diagnostics.
Novel biomarker antibody development using our AI antibody design platform — ideal for proprietary diagnostic targets with no commercial antibody available.
OEM (Original Equipment Manufacturer) means you provide the antibody sequence or hybridoma, and AntibodyLLM manufactures it to your specifications under your brand. ODM (Original Design Manufacturer) means AntibodyLLM designs and develops the antibody from scratch based on your target and application requirements, then manufactures it for you. ODM adds the upstream antibody discovery and optimization service.
Yes. AntibodyLLM has experience producing antibody components for IVD kits registered with NMPA (China), FDA (USA), and CE-IVD (Europe). We provide full technical documentation including raw material specifications, manufacturing process descriptions, QC specifications, stability data, and batch release CoAs that comply with registration filing requirements.
All OEM engagements are governed by a comprehensive confidentiality and IP agreement before any technical information is shared. Client-provided sequences remain client IP. Antibodies developed under ODM arrangements can be structured with exclusive licensing or full IP assignment to the client. We operate strict data compartmentalization to prevent cross-client information exposure.
Available conjugations include: enzyme labels (HRP, AP), biotin, streptavidin, fluorescent dyes (FITC, PE, APC, Cy3, Cy5), colloidal gold for LFA, and AMPPD/ABEI acridinium for chemiluminescence. Site-specific conjugation using engineered cysteines or non-natural amino acids is available for homogeneous, high-performance labeling critical to high-sensitivity immunoassays.
For repeat orders from an existing cell line: 4–6 weeks for production, QC, and delivery. For a new antibody sequence (no cell line established): 14–20 weeks including cell line development. For expedited research-grade production using transient expression: 2–3 weeks. Long-term supply agreements can include safety stock and scheduled production runs to minimize lead time risk.
Yes. Exclusive supply agreements are available under which AntibodyLLM commits to produce the specified antibody exclusively for your organization for a defined territory and time period. Exclusivity is typically tied to minimum annual purchase commitments. Non-exclusive arrangements are available for smaller volume requirements without minimum commitments.
Tell us your target, format, scale, and timeline. We'll propose an OEM solution within 48 hours.
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