Services Offered
FDA-compliant and platform agnostic phase-based Design Control processes are utilized for product development of diagnostic assays (reagents, calibrators, controls, calibration verifiers, and proficiency testing materials) from research and development to product transfer.
- IVD Assay Development
- Technology Transfers
- Packaging Development
- Stability Testing
- Regulatory Support
- Technical Support
- Custom QC Testing
Benefits of Outsourcing IVD Assay Development
✓ Access Bio-Techne’s product library & expertise
✓ Increase speed to market
✓ Manage Budget & Capital
✓ Free up internal resources
✓ Dependable Manufacturing and Supply
IVD Assay Development Phases
- Assay development projects start with research and planning, along with customer meetings to define product requirements.
- Thorough research is performed on the target to understand its chemical and biological properties, its binding partners, and isoforms, to assess specificity
- Research into applicable predicate assays
- Investigation into reagents: candidate antibodies, proteins, enzymes, etc. and their availability are determined
- Dedicated program manager is assigned to the project
- Much of the assay optimization occurs in this phase. Reagents are assessed to determine the best combination to meet the product requirements determined in Phase 0
- Assay is designed to meet CLSI guidelines
- If applicable onboarding and training to a new platform is the first step in this phase
- Project updates shared regularly (weekly --> monthly)
- The optimal reagents are evaluated for assay specificity, quantification ranges (LOB, LOD, LOQ), sample performance, and initial stability
- Pilot lots of reagents are examined to verify assay performance before entry into Phase 3
- Incorporated minor changes identified in Phase 1 testing to improve robustness
- 2 reagent lots produced with varying biologically derived components
- In Phase 3 all required testing determined in Phase 0 is performed
- The 3 lots of reagents with varied biologically derived components
- Performance testing against CLSI guidelines is performed
- Calibrators and controls are produced with traceable material.
- Regulatory dossier is provided to support customer quality and regulatory requirements
- Stability studies initiated
- Transfer of the assay from the development team to Operations, QC and QA
- Scale-up to achieve commercial volumes
- If applicable, kitting is performed
- Establish supply agreement that meets commercial needs
- Implement logistics plan to distribute bulk materials or finished kits to customer sites
Technology Deployed:
Technology Deployed:
- Chemiluminescence
- Homogeneous Immunoassay
- Clinical Chemistry
- Lateral Flow
- ELISA
Recent Development Projects:
Recent Development Projects:
- Neuro/Alzheimer's markers
- Regenerative Medicine
- Toxicology:
- Therapeutic Drug Monitoring (TDM)
- Drugs of Abuse
- Cell & Gene Therapy
Our Commitment to Quality
Our Commitment to Quality
- ISO 13485:2016
- Health Canada
- FDA 21 CFR Part 820
- MDSAP
- ISO 14001
- US DEA
- ISO 9001:2015
- USDA
- IVDD (IVDR in process)
Additional IVD Capabilities
Custom Controls & Calibrators
Custom Controls & Calibrators
- Hematology/Flow Cytometry
- Cardiac Markers
- Serum Proteins
- Urinalysis & Urine Chemistry
- Blood Gas/Electrolytes
- CO-Oximetry
-
Glucose/Diabetes
IVD Contract Manufacturing
IVD Contract Manufacturing
- Custom Controls & Calibrators
- Assay Development
- IVD Manufacturing
- Technology Transfer
- Packaging Development
- Regulatory Support
IVD Raw Materials
IVD Raw Materials
- Cancer
- Cardiovascular
- Drugs
- Endocrine/Thyroid
- Serum Proteins
- Infectious Disease
- Steroids
- reKom Biotech