The power of structure/function relationships has been proven time and time again. In order to realize and analyze this relationship quickly, we have expanded our North American bioassay offerings to be in-line with those found in our Erkrath, Germany and Edinburgh, UK facilities while also bringing Surface Plasmon Resonance (SPR) binding affinity services via the addition of a Biacore T200 instrument at our Shrewsbury, MA site.
SPR is a well-recognized methodology for determining the binding affinity of drug products against physiologic targets, providing a reliable and quantitative assessment of drug function. The data SPR provides is a key component of CMC characterization, and is especially useful for antibody-based therapies.
Our SPR team has expertise in developing Biacore assays for a number of different interacting systems relevant to biopharma, and can utilize novel formats to quantify binding affinity for all stages of your drug development process, from screening to lot release.
SPR can enhance your biologic drug development by:
- Quantifying the kinetic "on" and "off" rates in protein-protein and protein-small molecule systems, as well as the thermodynamic affinity constant, KD. Sample projects include antibody drug products tested for affinity to Fc-gamma receptors, FcRN, or C1q complex.
- Determining the amount of active material in drug product by Biacore concentration analysis.
- Domain mapping the API molecule by identifying secondary binding partners and assessment of multiple binding events.
- Assessing of glycosylation patterns and the effect on drug function (in conjunction with mass spectrometric assays).
Shrewsbury's bioassay offerings feature:
- Lab spaces equipped with incubators (CO2/RH), plate readers, liquid handlers, refrigerators, freezers, and biosafety cabinets.
- Assays including, but not limited to, cell proliferation, ADCC, and ADCT
- Cell culturing (MCB and WCB generation)
- R&D and GMP capabilities
- Well-versed and knowledgeable staff to support bioassays for gene therapies
Bioassays play a critical role in product development and manufacturing. They are necessary to ensure the quality and safety of biological products. SPR can be used to generate data developing an effective assay. In some instances, it can be used to replace more complex, cell-based assays. Offering both bioassay services and SPR in one facility can help streamline your drug development process and saves time by bringing your product to market faster.
If you are interested in learning more about the Shrewsbury facility, or to inquire about SPR, bioassays, or any of our available services, contact us at [email protected].