ISO 13485 Certified Antibody Production
Monoclonal & Recombinant Antibodies for IVD and Medical Device Applications
Partner with German excellence: ISO 13485:2016 certified facility | IVDR/MDR compliant | cGMP production | Complete regulatory documentation
Professional Antibody Production for Regulated Markets
Developing an in vitro diagnostic (IVD) device or medical device that requires antibodies? Don't let regulatory compliance slow you down. Our ISO 13485-certified antibody production services provide the quality, documentation, and regulatory compliance your medical device approval requires.
Through our partnership with a specialized German contract manufacturer with full ISO 13485:2016 certification, we deliver both monoclonal and recombinant antibodies that meet the stringent requirements of EU IVDR, MDR, and FDA regulations.
Why Medical Device Companies Choose Our Antibody Services
- Regulatory Certainty: ISO 13485 certification eliminates risk during medical device approval process
- Complete Documentation: Full technical files suitable for regulatory submissions to FDA, EMA, and notified bodies
- Consistent Quality: cGMP production ensures batch-to-batch reproducibility critical for diagnostics
- Scalability: From development (mg) to commercial production (grams to kilograms)
- Supply Security: German manufacturing with long-term supply agreements available
- IP Protection: Strict confidentiality under German and EU law
Antibody Production Service Options
Monoclonal Antibody Production
Traditional hybridoma-based monoclonal antibodies with proven track record in IVD applications
Complete Workflow:
- Antigen preparation & immunization
- Hybridoma generation & screening
- Clone selection & characterization
- Scale-up in ascites or bioreactor
- Purification (Protein A/G, affinity, ion exchange)
- Formulation & stability studies
- Complete documentation package
Typical Timeline:
4-6 months from immunization to final product delivery
Scale Range:
10 mg to 100+ grams
Request Detailed Protocol →Recombinant Antibody Production
Modern recombinant antibodies with superior consistency, scalability, and no animal use
Complete Workflow:
- Antibody discovery (phage display, immunization + sequencing)
- Gene synthesis & optimization
- Expression vector construction
- Stable cell line development (CHO, HEK293)
- Clone screening & characterization
- Bioreactor scale-up
- Purification & analytics
- Comprehensive documentation
Typical Timeline:
5-8 months from gene sequence to final product
Scale Range:
10 mg to multi-kilogram scale
Request Detailed Protocol →Choosing Between Monoclonal vs. Recombinant Antibodies
Monoclonal (Hybridoma) Antibodies - Best for:
- Proven antibody pairs with established performance
- Simpler regulatory path (well-established technology)
- Projects where you already have validated hybridomas
- Cost-sensitive applications at moderate scale (mg to low gram)
Recombinant Antibodies - Best for:
- Superior batch-to-batch consistency (critical for diagnostics)
- High-volume production (multi-gram to kg scale)
- Antibody engineering for improved performance
- Avoiding animal use (important for some markets)
- Long-term supply security (no hybridoma instability)
- Humanized or fully human antibodies for therapeutic companion diagnostics
Contact us for expert consultation on the best approach for your application →
Our ISO 13485-Compliant Production Process
Project Consultation & Feasibility
Activities: Technical discussion of your antibody requirements, antigen characteristics, intended use, regulatory requirements, and timeline. We assess feasibility and provide detailed project plan.
Timeline: 1-2 weeks
Deliverable: Technical proposal with timeline and quote
Antibody Generation
Monoclonal Path: Antigen preparation → Immunization → Fusion → Screening → Clone selection
Recombinant Path: Antibody discovery (phage display/B-cell sorting) → Sequencing → Gene synthesis
Timeline: 8-12 weeks (monoclonal) | 6-10 weeks (recombinant)
Deliverable: Characterized antibody clones with binding data
Cell Line Development & Banking
Activities: Stable cell line establishment (recombinant) or hybridoma expansion/banking (monoclonal). Master Cell Bank (MCB) and Working Cell Bank (WCB) creation with full characterization.
Timeline: 8-12 weeks
Deliverable: Cryopreserved cell banks with documentation
Process Development & Optimization
Activities: Cell culture optimization, bioreactor parameter development, purification method development, formulation studies. All processes validated per cGMP and ISO 13485 requirements.
Timeline: 6-10 weeks
Deliverable: Validated production process with batch records
cGMP Production
Activities: Production run(s) in ISO 13485-certified facility. Complete in-process controls, environmental monitoring, and documentation per quality management system.
Timeline: 2-4 weeks per batch
Deliverable: Purified antibody with batch record
Quality Control & Release
Testing: Purity (SDS-PAGE, SEC-HPLC, CE-SDS), binding activity (ELISA, SPR), endotoxin, sterility, identity confirmation, stability. Full QC testing per specifications.
Timeline: 2-3 weeks
Deliverable: Released product with Certificate of Analysis
Documentation & Delivery
Documentation: Complete technical file including: manufacturing records, QC data, stability studies, analytical methods, risk assessments, process validation reports – all suitable for regulatory submissions.
Timeline: 1 week
Deliverable: Final product + comprehensive documentation package
Comprehensive Quality Control Testing
Every antibody batch undergoes extensive quality control testing to ensure it meets specifications for medical device use:
| Test | Method | Specification | Purpose |
|---|---|---|---|
| Purity | SDS-PAGE, SEC-HPLC | >95% (typical) | Ensure minimal contaminating proteins |
| Identity | Western blot, Mass spec | Confirmed | Verify correct antibody produced |
| Concentration | UV280, BCA, Bradford | As specified | Accurate dosing for assays |
| Binding Activity | ELISA, SPR, flow cytometry | EC50/KD as specified | Functional performance validation |
| Endotoxin | LAL assay (kinetic chromogenic) | <0.1 EU/mg (typical) | Critical for diagnostic accuracy |
| Sterility | USP<71> (14-day incubation) | No growth | Ensure microbiological safety |
| Aggregation | SEC-HPLC, DLS | <5% aggregates | Stability and performance indicator |
| pH | pH meter | As specified (typically 7.0-7.4) | Stability and formulation control |
| Appearance | Visual inspection | Clear, no particulates | Quality indicator |
| Stability | Accelerated & real-time studies | Retain specifications over shelf-life | Support regulatory filing and storage |
Documentation Provided with Every Batch
- Certificate of Analysis (CoA): All QC test results with acceptance criteria and actual values
- Manufacturing Batch Record: Complete production history with in-process controls
- Analytical Methods: Validated test methods used for QC
- Stability Data: Available stability studies supporting shelf-life claims
- Raw Material Traceability: Documentation for all starting materials
- Certificates: ISO 13485 certificate, facility certifications
- Safety Data Sheet (SDS): Handling and safety information
Applications in IVD and Medical Devices
Immunodiagnostic Assays
- ELISA (sandwich, competitive, indirect)
- Chemiluminescent immunoassays
- Lateral flow assays (LFA)
- Immunoturbidimetric assays
- Multiplex bead-based assays
Point-of-Care Testing
- Rapid diagnostic tests (RDTs)
- Lateral flow devices
- Portable immunoassay platforms
- Biosensor applications
Clinical Biomarker Detection
- Cardiac markers (troponin, BNP)
- Infectious disease antigens/antibodies
- Tumor markers
- Hormone assays
- Inflammation markers (CRP, PCT)
Companion Diagnostics
- PD-L1 detection for immunotherapy
- HER2 testing for targeted therapy
- Pharmacokinetic assays
- Anti-drug antibody (ADA) detection
Pricing & Project Structure
Antibody production costs vary based on project complexity, scale, and timeline. We offer transparent pricing with no hidden fees.
Monoclonal Antibody Projects
Typical Investment Range:
- Discovery to 100mg: €25,000 - €45,000
- Discovery to 1g: €40,000 - €70,000
- Additional production runs: €5,000 - €15,000 per gram
Prices depend on antigen complexity, number of immunizations, screening requirements, and QC specifications.
Recombinant Antibody Projects
Typical Investment Range:
- Cell line development + 100mg: €35,000 - €60,000
- Cell line development + 1g: €50,000 - €90,000
- Production from existing cell line: €3,000 - €10,000 per gram
Economies of scale apply at larger volumes (>10g). Contact us for multi-kg pricing.
What's Included in Project Cost
- All development work (immunization/discovery, screening, characterization)
- Cell line development and banking (MCB/WCB)
- Process development and optimization
- Production in ISO 13485-certified facility
- Comprehensive QC testing
- Complete documentation package for regulatory use
- Project management and regular updates
- Technical support for assay integration
Not Included: Antigen preparation (if we don't produce it), specialized analytics beyond standard QC, accelerated timeline fees
Ready to Start Your Antibody Project?
Our experts will help you select the optimal antibody production strategy and navigate ISO 13485 requirements.
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