Antibody Development against 


Oligonucleotide therapeutics are single-stranded synthetic oligonucleotides and often show modifications in their structure to improve PK properties and stability. They generally target RNA transcripts and reduce or modify the corresponding protein expression. For example, Anti-sense oligonucleotides (ASO) are complementary to a specific mRNA that can impede the expression of a gene e.g., by inhibiting transcription and translation of the corresponding protein. Unlike monoclonal antibodies, the oligonucleotides are relatively small with fewer epitopes and are delivered to immune restricted sites to remain locally confined. Moreover, they can trigger an immune response and are able to elicit the formation of anti-drug antibodies (ADAs). Therefore, regulatory agencies require the testing of immunogenicity and reporting of the data as part of new drug applications. This necessitates highly specific and sensitive antibodies for the development of an assay to detect ADAs in patient samples.

Crucial to the development of these bioanalytical assays are antibody reagents that specifically recognize modified oligonucleotides. However, generating modified oligonucleotide-specific antibodies is not a trivial task, as it presents challenges such as poor antigen immunogenicity and the need to differentiate between the modified therapeutic molecules and endogenous counterparts. 

Antibody Development

BioGenes offers the generation of polyclonal antibodies against a variety of oligonucleotide therapeutics. We have ample expertise in enhancing the immunogenicity of oligonucleotides, the application of various adjuvants and administration routes, as well as the design of effective purification strategy for the generation of high titer anti-sera.

Phase 1 - Expert consultation

  • Definition of the project’s aim 
  • Thorough discussion and recommendations on antigen design, for example, oligonucleotides are recommended to be conjugated to keyhole limpet hemocyanin (KLH) for immunization

Phase 2 - Special immunization scheme

  • The unique ontogeny of rabbit B cells supports the use of rabbits as the preferred host-species for the generation of a strong immune response
  • We offer unique immunization strategies, that include the testing of the pre-immune sera before the immunization of a suitable group of rabbits on a case-by-case basis 

Phase 3 - ELISA screening & titer test

  • Blood samples are collected at regular intervals and screened against the biotinylated oligonucleotides in an ELISA
  • Based on the antibody response, the immunization strategy can be adjusted to achieve high antibody titers 

Phase 4 - Customized affinity purification strategy

  • Once a sufficient titer has been reached, appropriate antisera from individual animals are pooled and specific antibodies are purified using custom-built oligonucleotide-mediated affinity chromatography columns                                                                                                                     

Phase 5 - QC and shipping

  • Transfer of the antibodies to FyoniBio or the customer’s preferred CRO for assay development

Approximate project duration: 4-6 months

Pooled Scientific Expertise

To provide you with an all-inclusive service, BioGenes works closely together with FyoniBio. By combining our scientific expertise, we can offer you an all-in-one package ranging from custom antibody and assay development to ELISA validation and the analysis of pre-clinical and clinical samples according to GCLP guidelines. However, customers can also choose to independently obtain individual services from either company.


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