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 Fraunhofer IME also offers contract based tailor made 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 long term 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 analysis.
Apply for free SPR services provided by the EU project TRANSVAC2
Fraunhofer IME offers contract based assay development and analytical services. Usually these projects are initiated upon specific customer requests or suggested by Fraunhofer IME to potential customers. Currently there is another unique possibility to access the SPR-assay development capacities at Fraunhofer in the context of free services provided by TRANSVAC2.
TRANSVAC2 http://transvac.org/ is a collaborative infrastructure project funded by the European Commission (EC), initially under the 7th Framework Programme (FP7) and currently under Horizon 2020. The project is a joint effort of leading European groups working in the field of vaccine development, and is coordinated by the European Vaccine Initiative (EVI). TRANSVAC is designed to accelerate vaccine development by enhancing European vaccine research and training, and increase sustainability of EC vaccine projects by implementing a permanent research infrastructure for early vaccine development.
TRANSVAC2 offers several free services http://transvac.org/services.html and trainings http://transvac.org/training.html related to vaccine development provided by the different partners. TRANSVAC seeks to support vaccine-related projects currently in the preclinical phase of development. TRANSVAC’s goal is to further support and accelerate vaccine-related projects by providing access to the services and expertise contained within the TRANSVAC Infrastructure.
In the context of this service IME will develop and perform assays that can be used to either:
- Characterize the interaction between biomolecules (e.g. protein and natural ligand, protein and conformational mAb) on quantitative and qualitative level.
- Characterize, and quantify antibody responses in serum samples (before, during or after immunization studies).
For vaccine development and vaccine manufacturing these assays can provide a high value. Using so called calibration-free concentration analysis (CFCA) it is usually possible to address the total concentration of vaccine antigen specific antibodies in serum samples. Analysis interaction of vaccine antigens with natural ligand or antibodies can be used to investigate the activity and homogeneity of the protein and can be implemented during vaccine candidate development, process development and quality control.
It is possible to apply for any of the services by following the instructions for application http://transvac.org/apply.html published on the TRANSVAC2 Website. TRANSVAC will operate a permanent call whereby applications may be submitted at any time and will be processed at pre-defined cut-off dates. Next cut-off date is december 15th 2018.
For more Info on TRANSVAC2 related services offered by Fraunhofer IME, do not hesitate to contact Holger Spiegel (firstname.lastname@example.org).