DevLab bio is your one source for Contract Research Services and Clinical Diagnostic (CDX) services and w i l l bring your project to fruition while focusing on efficiency and quality results. Our multi-pronged capabilities provide a flexible and full-service approach to complement your business needs.
Contract Research Services: From small, focused research projects to development of novel assays or device, DevLab bio offers a full suite of Contract Research Services following current Good Laboratory Practices (cGLP). DevLab bio works closely with clients from diverse industries including cosmetics, academia, small startup biotech and large internationally renowned biotech companies.
Clinical Diagnostic (CDX) Services: Coordination of your project between our Contract Research Services team and Clinical Diagnostic (CDX) Services laboratory allows for efficient execution of pre-clinical and clinical trials that can assist you in accomplishing FDA 510(k) approval. Our CLIA-certified laboratory offers (CDX) services, specializing in immunology and molecular diagnostics.
DevLab bio specializes in assay and product development and offers services that include:
- FDA-Compliant Pre-Clinical Assay Development
- Clinical Trial Support through coordination with our CLIA-Certified CDX Laboratory
- Laboratory Developed Test (LDT) Establishment & Technology Transfer*
DevLab bio core research and assay development capabilities include:
- Immunoassay Test Development
- Cell Therapy Assay Development
- Gene Therapy Assay Development
- Pharmaceutical Delivery & Formulation Testing
- Product Formulation & Purity Testing
- CDX Medical Device Testing & Optimization
- Reagent QC Assay Development
- Bacterial & Mammalian Cell Culture
- Genetic Engineering (e.g. , CRISPR/Cas9, Cre/Lox)
- Plasmid Vector Construction
- Recombinant Protein Expression, Optimization & Purification
- Next Generation Sequencing (NGS)
DevLab bio also offers a variety of specialty and custom research and development services. For more information and to connect with our team, contact us at [email protected] or call us at 866.983.0667.
See our attached poster from 2021 ASCP.