Why Partner with Bio-Techne Diagnostics?
Diagnostic Immunoassay Development and IVD Manufacturing Designed for a Wide Range of Technologies
End-to end diagnostic immunoassay development and IVD manufacturing designed for a wide range of technologies.
- Automated chemiluminescent and turbidimetric platforms
- Point‑of‑care devices
- High‑sensitivity formats
- Multiplex systems
Immunoassay Content Breadth and Depth
Foundational biomarker content reduces integration risk and supports platform specific assay optimization.
- Extensive libraries of antibodies and proteins powered by R&D Systems:
- 33,000 human proteins
- 700,000 antibody products
- 6,500 monoclonal antibodies developed in-house
- 100,000 sister clones
- 200,000 peer-reviewed citations
- Custom biomarker and antibody production options designed for IVD scalability
- Recombinant antibody engineering
- Specialized small molecules and conjugates
- Diagnostic-ready controls and calibrators
Assay Lifecycle Management:
Prototype → Regulated IVD
We manage the entire development and IVD commercialization lifecycle with critical risk-reduction strategies including:
- Recombinant conversion of monoclonal antibodies to prevent supply drift
- Stabilized liquid and lyophilized reagents and controls for global shipping and point of care environments
- Diversified sourcing and safety stock programs
- Design for manufacturing assessments
- Documentation aligned with regulatory expectations for global markets
Analytical Studies Aligned to CLSI/CLIA/FDA Expectations
Analytical Studies Aligned to CLSI/CLIA/FDA Expectations
Validation workflows structured to support RUO regulated → IVD transitions:
- Sensitivity, accuracy, linearity, recovery
- Precision (intra-run, inter-run, inter-lot, multi-site)
- Detection capability: LOB/LOD/LOQ/ULOQ
- Interference and specificity studies
- Realtime, accelerated, onboard/open vial stability
- Reagent, calibrator, and control stability programs
Scalable, Compliant Manufacturing & Supply Systems for Reliable Assay
Scalable, Compliant Manufacturing & Supply Systems for Reliable Assay
- Master service agreements
- KPI monitoring (yield, cycle time, OTD, defect rates)
- Integrated stability program milestones
- Lot sequestration and inventory strategies
- Change control aligned to analytical comparability
Operations Under Robust Global Regulatory & Quality Frameworks
Operations Under Robust Global Regulatory & Quality Frameworks
Regulatory readiness for global distribution:
- ISO 13485, ISO 9001, cGMP
- US FDA registration and MDSAP certification
- IVDR and Health Canada support
- Complete traceability, auditready documentation, Certificates of Analysis
Contract Manufacturing for Diagnostics
IVD Contract Manufacturing architecture & technologies supporting liquid and dry IVD reagent formats
Liquid Formulation
Liquid Formulation
- Multi‑thousand‑liter batch formulation (up to 9,000L)
- High‑throughput liquid filling (3,000–24,000 units/hr)
Powder Formulation
Powder Formulation
- Dry Format Manufacturing
- Powder blending
- Reagent Tablets
- Lyophilization for long-term stability
Kitting & Packaging
Kitting & Packaging
- Packaging development
- In‑line labeling (up to 27,000/hr)
- Kitting assembly and packaging
- Final product QC testing
- Ambient and cold‑chain distribution logistics
Baseline IVD CDMO Expectations vs. Bio-Techne Diagnostics
| Criteria | Baseline CDMO Expectations | Bio-Techne Diagnostics |
|---|---|---|
| Scope & Model | End-to-end services (formulation; filling/packaging; some on-market support) | Foundational critical biomaterials + custom immunoassay development + manufacturing with lifecycle governance and OEM supply |
| Biomaterials Access | Antibody/antigen sourcing; custom work varies | Large in-house catalogs; access to non-catalog sister clones; top-tier custom antibody capabilities; recombinant conversion/engineering |
| Assay Development | Immunoassay build; platform translation as needed | ELISA / chemiluminescent / turbidimetric / point of care / multiplex; matched antibody pair screening; RUO→IVD/IVDR pathways |
| Analytical Validation | CLSI-aligned programs; scope varies by project | Comprehensive CLSI EP-series coverage (precision, linearity, detection, interference, etc.); stability programs |
| Manufacturing Capacity | Liquid & dry formulation; lyophilization; throughput often undisclosed | Liquid formulation up to 9,000 L; high-throughput liquid filling (3 mL at 3,000/hr; 6 mL at 6,000/hr; ampoules at 24,000/hr); dry formulation; tablets; lyophilization |
| Labeling & Packaging | Filling/packaging with labeling; rates vary | In-line labeling up to 27,000/hr; kit assembly; final kitted product testing; cold-chain logistics |
| QA/RA Certifications | ISO 13485; GMP; FDA registration common | Audit-ready documentation; ISO 13485/9001; cGMP; IVD, IVDR, MDSAP, Health Canada support |
| Technology Transfer | Process documentation; pilot lots as needed | Structured phase-gated programs with formal project management; pilot lots; KPI governance; change control |
| Global Footprint | Regional hubs; capacity varies | Multi-site US footprint with global distribution |
Ready to Advance Your IVD Development Program?
Bio-Techne Diagnostics delivers integrated IVD assay development, on-platform optimization, validation, and scalable GMP diagnostic manufacturing backed by biological depth and regulatory strength.
✓ Access Bio-Techne Diagnostics' product library & expertise
✓ Increase speed to market
✓ Manage budget & capital
✓ Free up internal resources
✓ Dependable manufacturing and supply
