Developing a biological product with the desired stability, efficacy and proper clinical presentation can be challenging. Product degradation and loss of activity can occur via one or more mechanisms such as:

• Hydrolysis
• Aggregation
• Multimer formation
• Deamidation
• Oxidation
• Denaturation
• Conformational changes
  

Understanding the specific environmental conditions that destabilize your protein is the goal of Stability FingerPrinting. This program allows our clients to develop a complete, in-depth understanding of a protein’s response when subject to variations in:

• pH
• Ionic strength
• Temperature
• Shear stress
• Freeze/thaw cycles
  

During this program, product conformational integrity and stability will be monitored using techniques such as intrinsic and extrinsic fluorescence, right-angle light scattering, SDS-PAGE and SE-HPLC. The conditions and assays used to identify product instabilities will also become important tools used during formulation development.

To request more information on our Stability FingerPrinting services, please click here.  

Case Study – Increase Bioavailability

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Case Study – Formulation/Dosage Form Change

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Case Study – Analytical Development