Experts in Custom ELISA Development and Production
Experts in Custom ELISA Development and Production

Custom ELISA Development

BioGenes has a wealth of experience in the development of robust immunoassays for leading pharmaceutical and biotech companies worldwide. Our technical expertise is unrivaled, and we work to the highest standards - giving you the confidence you need to outsource even your most demanding projects.

For over 20 years we have successfully developed and qualified ELISAs for several purposes.

Expertise in ELISA development for:

  • Quality control (custom HCP assays and assays for other residuals)
  • Drug discovery and drug development (PK assays and immunogenicity assays)
  • Biomarker detection
  • Diagnostic kits (human and veterinary)
  • Detection of small molecules, e. g. TNT, Ethylglucoronide and cytostatic agents 

Key strengths:

  • Strong commitment to quality and service
  • 20 years of experience in the development of ELISAs against various targets
  • Flexibility: Ability to deliver customized solutions for challenging projects and special requests
  • Reliability: We reach milestones and keep deadlines
  • Proactive project management: solid, honest and consistent communication 

BioGenes provides a wide range of GMP relevant services, including immunoassay development, optimization, qualification/ pre-validation, and kit production. Immunoassays are designed as competitive and sandwich assays. Customers can order single services or full-service packages.

As a one-stop-service provider BioGenes offers a wide range of comprehensive analytical services to accomplish your ELISA development project.

ELISA development services include:

  • In-house antibody development (immunization of rabbits, goats, sheep)
  • Comprehensive antibody services (biotinylation, pair search, testing of cross reactivities etc.)
  • Characterization of antibodies (analytical services)
  • ELISA development and assay optimization
  • Testing of matrix effects
  • Pre-validation according to ICH guidelines, including demonstration of the assay performance, meeting accuracy and precision-acceptance criteria
  • Production of complete kits or assay components to the agreed quality and quantity
  • Stability testing of kits and assay components
  • Continuous quality control of all components