ISO 13485 Certified Custom Assay Development & Production
End-to-End Development of ELISA, Lateral Flow, and Bioassays for IVD Devices
From concept to commercial kit: ISO 13485:2016 certified | IVDR/MDR compliant | Complete validation | German cGMP manufacturing | Full regulatory documentation
Professional Assay Development for Medical Diagnostics
Developing a new IVD device or diagnostic test? Don't navigate complex assay development and regulatory requirements alone. Our ISO 13485-certified custom assay development services take your concept from initial feasibility through validated production, ensuring your diagnostic achieves optimal performance and regulatory compliance.
Through our partnership with a specialized German manufacturer, we provide complete assay development and production services for ELISA, lateral flow assays, bioassays, and other immunoassay formats – all under full ISO 13485 certification suitable for IVD and medical device applications.
Why Choose Our Assay Development Services
- Complete Development: From feasibility to commercial production under one roof
- ISO 13485 Certified: All development and manufacturing in certified facility
- Multiple Assay Formats: ELISA, LFA, LIA, bioassays, multiplex platforms
- Regulatory Expertise: IVDR/MDR compliant development and documentation
- Custom Reagents: In-house antibody and protein production capability
- Full Validation: Analytical and clinical validation per regulatory requirements
- Technology Transfer: Seamless transfer to your facility or our production
- German Quality: Made in Germany precision and reliability
Assay Development Capabilities
ELISA Development
Enzyme-Linked Immunosorbent Assay
Formats:
- Sandwich ELISA (most common for IVD)
- Competitive ELISA
- Indirect ELISA
- Multiplex ELISA
Applications:
- Quantitative biomarker detection
- Infectious disease diagnostics
- Hormone/cytokine measurement
- Pharmacokinetic assays
- Clinical chemistry panels
Key Features:
- Wide dynamic range (3-4 logs)
- High sensitivity (pg/mL detection)
- Excellent reproducibility
- Automation-compatible
Lateral Flow Assay (LFA)
Rapid Diagnostic Tests
Formats:
- Sandwich LFA (antigen detection)
- Competitive LFA (small molecules)
- IgG/IgM antibody detection
- Multiplex lateral flow
Applications:
- Point-of-care testing (POCT)
- Infectious disease screening
- Pregnancy/fertility testing
- Drug of abuse detection
- Food safety testing
Key Features:
- Rapid results (5-30 minutes)
- No instrumentation required
- Long shelf life (18-24 months)
- User-friendly visual readout
Luminescence Immunoassays
Chemiluminescent & Fluorescent
Formats:
- Chemiluminescent immunoassay (CLIA)
- Electrochemiluminescence (ECL)
- Time-resolved fluorescence (TRF)
- Fluorescence polarization (FP)
Applications:
- Ultra-sensitive biomarker detection
- Cardiac marker panels
- Tumor marker screening
- Hormone diagnostics
- High-throughput screening
Key Features:
- Highest sensitivity (fg/mL)
- Broad dynamic range (5+ logs)
- Minimal sample volume
- Fully automated platforms
Bioassays
Cell-Based & Functional Assays
Formats:
- Cell viability/proliferation assays
- Reporter gene assays
- Neutralizing antibody assays
- Cytotoxicity assays
Applications:
- Potency testing (biologics)
- Immunogenicity assessment
- Functional antibody detection
- Cytokine bioactivity
- Anti-drug antibodies (ADA)
Key Features:
- Measures biological function
- Regulatory-preferred for biologics
- High clinical relevance
- Quantitative readouts
Multiplex Assays
Multi-Analyte Detection
Formats:
- Bead-based multiplex (Luminex)
- Planar multiplex ELISA
- Multiplex lateral flow
- Microarray immunoassays
Applications:
- Cytokine/chemokine panels
- Infectious disease panels
- Autoimmune antibody profiling
- Allergy testing
- Cancer marker panels
Key Features:
- Multiple targets simultaneously
- Sample volume savings
- Cost-effective screening
- Comprehensive diagnostic profiles
Specialized Assays
Custom Solutions
Capabilities:
- Turbidimetric/nephelometric assays
- Agglutination assays
- Western blot development
- Dot blot assays
Applications:
- Clinical chemistry
- Coagulation testing
- Blood typing
- Protein identification
- Research use only (RUO) kits
Key Features:
- Tailored to specific needs
- Novel detection methods
- Platform compatibility
- Flexible development
Our Assay Development Process
Structured, phase-based approach ensures optimal performance and regulatory compliance:
Feasibility & Design
Activities:
- Target analyte assessment and literature review
- Format selection (ELISA, LFA, bioassay, etc.)
- Antibody/reagent sourcing strategy
- Preliminary performance criteria definition
- Regulatory pathway discussion
- Project timeline and budget proposal
Timeline: 2-4 weeks | Deliverable: Technical proposal with development plan
Reagent Development
Activities:
- Antibody generation or sourcing (if needed)
- Antigen/protein production (if needed)
- Reagent characterization and optimization
- Antibody pair screening (sandwich assays)
- Conjugate development and optimization
Timeline: 8-16 weeks (depends on reagent availability)
Deliverable: Qualified reagents with characterization data
Assay Optimization
Activities:
- Systematic optimization of all assay parameters:
- Reagent concentrations
- Incubation times and temperatures
- Buffer compositions
- Sample dilution protocols
- Sensitivity and dynamic range optimization
- Matrix interference studies
- Cross-reactivity screening
- Preliminary stability assessment
Timeline: 6-10 weeks | Deliverable: Optimized assay protocol
Analytical Validation
Activities per ICH/CLSI guidelines:
- Precision: Intra-assay, inter-assay, inter-lot CV
- Accuracy: Recovery studies, spike-and-recovery
- Sensitivity: Limit of detection (LOD), limit of quantitation (LOQ)
- Linearity: Working range determination
- Specificity: Cross-reactivity, interference testing
- Stability: Reagent and sample stability studies
- Robustness: Tolerance to parameter variations
Timeline: 8-12 weeks | Deliverable: Validation report per regulatory requirements
Clinical Validation (if required)
Activities:
- Clinical sample testing (sensitivity/specificity)
- Method comparison to predicate/reference
- Cut-off determination (qualitative assays)
- Clinical performance evaluation
- Statistical analysis per regulatory requirements
Timeline: 12-20 weeks (sample dependent)
Deliverable: Clinical validation report
Kit Development & Production
Activities:
- Kit configuration and component selection
- Formulation and stabilization studies
- Shelf-life studies (real-time and accelerated)
- Packaging design and validation
- Instructions for Use (IFU) development
- ISO 13485-certified production
- Lot release testing and documentation
Timeline: 12-16 weeks | Deliverable: Commercial-ready kit with documentation
Regulatory Support & Technology Transfer
Activities:
- Complete technical file compilation
- Risk assessment documentation (ISO 14971)
- Design verification/validation reports
- Post-market surveillance planning
- Technology transfer documentation (if transferring to your facility)
- Training materials and SOPs
Timeline: 4-8 weeks | Deliverable: Regulatory submission package
Total Project Timeline
Typical Development Timelines:
- ELISA Development: 9-15 months (concept to commercial kit)
- Lateral Flow Assay: 12-18 months (includes prototype iterations)
- Bioassay Development: 10-14 months
- Multiplex Assay: 12-20 months (complexity dependent)
Note: Timeline varies based on reagent availability, clinical validation requirements, and regulatory pathway. Accelerated timelines available for urgent projects.
Analytical Validation Parameters
Comprehensive validation per ICH, CLSI, and FDA guidelines:
| Validation Parameter | Method | Acceptance Criteria | Regulatory Requirement |
|---|---|---|---|
| Precision | • Intra-assay (n=20) • Inter-assay (3 days, n=20) • Inter-lot (3 lots) |
CV <10% (quantitative) CV <15% (bioassays) |
CLSI EP05, FDA |
| Accuracy | • Spike-recovery (3 levels) • Method comparison • Certified reference materials |
Recovery: 80-120% Correlation: R² >0.95 |
CLSI EP09, ICH Q2 |
| Sensitivity (LOD/LOQ) | • Limit of Blank (LoB) • Limit of Detection (LoD) • Limit of Quantitation (LoQ) |
LoD: Mean blank + 3SD LoQ: CV <20% |
CLSI EP17, ICH Q2 |
| Linearity | • Serial dilution (≥5 points) • Regression analysis |
R² >0.98 Recovery 80-120% |
CLSI EP06, ICH Q2 |
| Range | • Working range determination • Reportable range |
Covers clinical decision points Linear + precise range |
CLSI EP06 |
| Specificity | • Cross-reactivity (≥20 analytes) • Interference testing |
Cross-reactivity <5% No significant interference |
FDA, CLSI EP07 |
| Matrix Effects | • Parallelism • Sample dilution linearity |
Parallel slopes Recovery 80-120% |
CLSI EP14 |
| Stability | • Reagent stability (real-time, accelerated) • Sample stability |
Retain performance over claimed shelf-life | ICH Q1A, CLSI EP25 |
| Robustness | • Parameter variation studies • Different operators/instruments |
No significant performance change | ICH Q2 |
| Hook Effect (if applicable) |
• High-dose testing • Prozone evaluation |
Identified and documented Mitigation strategy |
FDA |
Clinical Sample Analysis Services
ISO 13485-compliant testing of clinical study samples:
Study Sample Measurement
Professional analysis of clinical samples for your diagnostic validation or research studies:
Services Include:
- Sample receipt and chain-of-custody
- Sample storage and handling per protocol
- Assay execution per validated SOP
- Data analysis and statistical evaluation
- Comprehensive study report
- Regulatory-compliant documentation
Sample Types:
- Serum, plasma, whole blood
- Urine, saliva, CSF
- Tissue lysates
- Cell culture supernatants
Compliance: GLP, GCP, 21 CFR Part 11
Biomarker & PK/PD Studies
Specialized assay services for pharmaceutical and biotech development:
Capabilities:
- Pharmacokinetics (PK): Drug concentration measurement
- Pharmacodynamics (PD): Target engagement biomarkers
- Immunogenicity: Anti-drug antibody (ADA) detection
- Biomarker Analysis: Disease/treatment response markers
Study Support:
- Method validation and transfer
- Sample analysis with QC
- Data management and reporting
- Regulatory documentation
- Audit support
Experience: Phase I-IV clinical trials, bioequivalence studies
Investment Guide
Assay development costs vary by format, complexity, and validation requirements. Transparent project-based pricing:
ELISA Development
Complete Development Package:
- With existing antibodies:
€35,000 - €65,000 - Including antibody generation:
€60,000 - €120,000
Includes:
- Optimization & validation
- Analytical validation report
- Kit development
- Stability studies (6 months)
- IFU and documentation
Timeline: 9-12 months
Lateral Flow Assay
Complete Development Package:
- With existing antibodies:
€50,000 - €90,000 - Including antibody generation:
€75,000 - €150,000
Includes:
- Prototype development
- Membrane/conjugate optimization
- Analytical validation
- Stability (12+ months)
- Reader compatibility (if needed)
Timeline: 12-18 months
Bioassay Development
Complete Development Package:
- Standard bioassay:
€40,000 - €80,000 - Complex cell-based:
€60,000 - €120,000
Includes:
- Cell line development/banking
- Assay optimization
- Validation per ICH Q2
- Reference standard qualification
- Technology transfer support
Timeline: 10-14 months
Additional Services & Costs
Clinical Validation (add-on):
- 50-100 samples: €15,000 - €30,000
- 100-300 samples: €30,000 - €60,000
- Includes: Testing, statistical analysis, clinical report
Sample Analysis Services:
- Per sample cost: €15 - €50 (volume dependent)
- Study setup fee: €2,000 - €5,000
- Includes: Analysis, QC, report generation
Regulatory Documentation:
- Technical file compilation: €5,000 - €15,000
- 510(k) support: €10,000 - €25,000
- CE marking support: €8,000 - €20,000
Ready to Develop Your Diagnostic Assay?
Our assay development experts will guide you from concept through regulatory approval.
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