Formulation Development
Avacta Analytical can provide services to assist in the development of biopharmaceutical formulations utilising higher order structural and aggregation propensity endpoints alongside more traditional analyses of formulation suitability. The relationship between structure and function/activity makes biophysical techniques essential for rapid, effective formulation development.
Having a characterisation fingerprint of the native molecule prior to any formulation or of a previously formulated version allows the study of each element of the protein therapeutics structure and comparation to structure and aggregation state of the therapeutic in a formulation under development.
Use of relatively high throughput biophysical technques such as DSC allows a rapid first pass evaluation of the protein and it's thermal stability. This can be followed by appropriate techniques for a more detailed characterisation of the appropriate samples and reducing the total amount of analyses required. Studies of pH, buffer and then individual excipients and their effects on the structure and aggregation of the therapeutic molecule when compared to the reference will define the most appropriate formulation which conserves the molecules essential structure and should provide maximum stability due to the low aggregation propensity.
Please contact us directly to discuss how we can assist your formulation development and for further information.