Choosing buffers and stabilizers that prevent aggregation and degradation
29 Apr 2026
Formulation & Stability
- What criteria are used to select buffers/additives during mAb purification? Are they driven by process requirements (e.g. chromatography), and/or also to protect against further loss of quality attributes (e.g. aggregation, fragmentation and charge-profile changes etc.) during the process itself. What are the best strategies to address these dual challenges?
- Based on the viral inactivation steps used, what are the best buffers/additives and how are they selected to protect mAb quality?
- Final DS and DP composition must be selected for enabling long-term storage in deep-frozen as well as liquid (2-8°C) state. The composition must be protective against various handling, transport and in-use stresses that the DP is subject to. What are some efficient material sparing techniques to address these requirements?
- How are the above considerations impacted for high concentration products (≥ 100 mg/mL) and for lyophilized products.
- How can efficient formulation design strategies, incorporating in-house experience as well as literature knowledge, be developed using machine learning/artificial intelligence? How can advanced computational techniques using structural modeling be used to address these questions?
