The PreScreen has been designed to:
In the PreScreen, the suitability for a particular protein for use in the HSC System is accomplished through the use of several distinct assays designed to establish baselines for comparison of future data and confirm that the protein, for which the formulation will be developed, can be used in SIC experiments successfully. The assays performed as part of this screen include:
Dynamic Light Scattering in the buffer received to establish a baseline hydrodynamic radius and polydispersity
Dynamic Light Scattering in SIC binding buffer to confirm that the binding buffer does not cause protein to aggregate while binding to the SIC matrix.
Differential Scanning Calorimetry in buffer received to establish a baseline for thermodynamic and conformational stability.
Differential Scanning Calorimetry in SIC binding buffer to confirmation that the binding buffer does not cause thermodynamic or conformational instability
Protein Binding Assays to different matrices used in the SIC experimental procedures to confirm that at least one of the matrices is capable of binding an acceptable level of the protein. Minimum concentration of protein bound to the matrix required to proceed is 4mg/ml bound to media.
Baseline buffer determination is used to identify the minimum components required to provide acceptable chromatograms.