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Monoclonal Antibody Development

BioGenes has a proven track record with more than 1,000 successfully completed monoclonal antibody (mAb) projects that resulted in the generation of highly specific and sensitive diagnostic reagents and their application in multiple R&D ELISA kits. With over 20 years of experience BioGenes possesses profound technical and analytical know-how and capabilities in the generation of highly pure and consistent antibodies at scalable amounts. Customized screening systems are implemented for the selection of the right clones against every antigen.

The hybridoma technology allows for the generation of genetically highly diverse populations of monoclonal antibody secreting cell lines. Our immunization strategies are designed to fully exploit the positive effects of in vivo affinity maturation of the antibodies to be generated and, thus, facilitate the development of highly specific and sensitive immunoassay reagents. Furthermore, our workflows ensure the provision of highly reliable and reproducible reagents for a broad spectrum of customer applications. 

Development Strategy

Each project is conducted in close cooperation with the customer and consists of different work phases, each of which can be adapted according to the project’s specific aims. 

Phase 1 - Expert consultation

  • Definition of the project’s aims and challenges
  • Thorough discussion of the antigen characteristics 
  • Support in antigen design 
  • Definition of screening set-up (inhibition tests and/or screenings of cross-reactants)

Phase 2 - Immunization

  • Antigen generation (peptide synthesis or antigen conjugation)
  • Antigen characterization
  • Immunization of mice according to BioGenes’ enhanced immunization protocol or customized protocols (upon request)
  • Titre determination and selection of mice for hybridoma generation


  • Optional: Prolongation of immunization schedule to achieve appropriate titres

 

Phase 3 - Cell fusion & hybridoma screening

  • Generation and selection of hybridoma cell lines
  • Screening for IgG producing hybridomas by ELISA

Options:

  • Testing of multiple cross-reactants for antibody characterization
  • Provision of spleen cells for customer processing 
  • Delivery of hybridoma cell suspensions for testing by the customer

Phase 4 - Cloning

  • At least two cloning cycles and screening for relevant hybridomas
  • Delivery of cell culture supernatants for each clone for in-house testing by the customer
  • Characterization of selected clones (isotype determination and mycoplasma testing)

Options:

  • Adaption to serum-free medium
  • Pair Search – antibodies will be biotinylated and tested in an ELISA to identify suitable capture and detector antibodies

Phase 5 - Delivery & preservation

  • Cryo preservation of the relevant hybridomas
  • Delivery of three cryo vials per clone

Approximate project duration: 5-8 months

Additional Services

Test Production

We recommend a test production if there is insufficient information on the production rate of a clone of interest or if you need antibody amounts of 50 mg or more. The test production is based on the affinity purification of the antibody from 350 ml cell culture supernatant. 

 

Large-Scale Antibody Production 

BioGenes offers the bulk production of monoclonal antibodies at various scales and quantities ranging from research (mg) to commercial (g) scale amounts per batch. The production is carried out with hybridoma cells specifically developed by BioGenes or with cells provided by the customer. 

 

Longterm Storage and Maintenance

Cell viability and the rate of antibody production from established hybridoma cell lines can diminish over time. In many cases, the antibody production can be restored by re-cloning the hybridoma cell line. The hybridoma re-cloning and development can be ordered separately, if necessary.

  • Routine maintenance once every two years (or other time intervals as requested by the customer)
  • Includes thawing, re-cultivation and additional cloning
  • Screening for high productivity and preparation of new vials for cryo conservation

 

Further Services & Information

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