The activity of pharmaceutical molecules such as antibodies, cytokines and small-molecule drugs is mediated by interactions with specific receptors or target molecules in the patient. The identification, development and quality control of pharmaceuticals therefore relies on the accurate qualitative characterization of interaction parameters such as specificity, binding affinity and stoichiometry.
Because extensive clinical studies are required during the later stages of drug development, the design, evaluation and approval of novel drugs can cost several hundred million Euros. Therefore the detailed characterization of new lead and target molecules must be completed at an early stage of the process.
In this context, SPR spectroscopy facilitates highly sensitive, quantitative biomolecular interaction analysis in real time, and provides important decision criteria for the selection and optimization of active pharmaceutical ingredients.
The Fraunhofer IME uses two powerful Biacore SPR instruments for biomolecular interaction analysis:
Biacore 2000 (GE Healthcare)
Biacore T100 (GE Healthcare)
These instruments are used for internal projects and collaborations, but the Frauhofer IME also offers contract based tailormade SPR analytics and assay development to customers from industry and academia.
The SPR-based analysis of monoclonal antibodies, recombinant antibodies and their fragments is a well-established core competence at the Fraunhofer IME which is constantly subject to refinement and development. A wide variety of assay formats is available, from initial screening to detailed characterization
and quality control in the context of GMP-compliant production of recombinant antibodies for clinical studies.
- Standard-based and standard-free concentration determination
- Determination of absolute and relative binding activities
- Determination of thermodynamic interaction constants
(kon, koff, KD, ΔH, ΔS)
- Competition assays
- Pairwise epitope mapping
- Fc-receptor binding
As well as these standard assay formats, the Fraunhofer IME helps to develop customized assay protocols for external customers addressing specific questions. The longterm experience of the IME SPR group facilitates the efficient development and validation of tailor-made analytical assays and decision criteria for most scenarios in the context of biomolecular interaction