Microcoat Biotechnologie GmbH

Produktion: As a globally operating contract manufacturer, we offer a large variety of diagnostic kit and component manufacturing service. We guarantee professional technology transfer and the implementation of a reliable and cost-effective production process that ensures sustainable and competitive product supply. Standard kit formats comprise ELISA, ELISpot, bead-based assays, latex agglutination and lateral flow kits.
- Cloning, expression and downstream processing of recombinant proteins - Modification and conjugation of antibodies and proteins
- Customized microplate and particle coating
- Dispensing/filling/labeling
- Freeze-drying, kit assembly
- DIN EN ISO 9001 and 13485

Forschungsschwerpunkte: Our service comprises the custom development of diagnostic assays, test components and new test formats to market-ready kits. We guide you in the benchmarking and selection of the optimal methodology, test format and components. Starting from an idea, a concept or a prototype, our aim is to develop the final product according to your requirements.
- Immunological assays (ELISA, cell-based, bead-based, lateral flow)
- Molecular assays (quantitative and qualitative PCR)
- Sample and matrix preparation protocols
- Depletion protocols
- Sample and reagent stabilization.

Services: We offer services in the fields of companion diagnostics, biological safety, clinical development and system evaluation to the pharmaceutical and life science industry worldwide. Our service portfolio comprises biomarker testing, pre-clinical and clinical study support in line with EU and US guidelines.
- Biomarker services
- PK and PD analysis
- Immunogenicity testing
- Non-clinical and clinical sample measurement
- Endotoxin and pyrogen testing
- Validation of diagnostic assays and assay platforms
- Method and system benchmarking
- GLP/GC(L)P/cGMP.

Vertrieb: Contract Manufacturing of diagnostic kits, components and bulk reagents Custom Development of diagnostic tests and products Laboratory Services including bioanalytical drug development support and non clinical and clinical sample measurement