Speaker: Dr. Christian Schöneich, University of Kansas
When: Tuesday, March 11, 2025, 12:30 PM EST
Learning Objectives:
- The role of transition metal impurities in protein photostability
- The role of formulation excipients in protein photostability
- The role of glycosylation
- Effect of temperature on light induced degradation reaction (i.e. 5oC vs room and elevated temperature)
- The pros and cons of amber color vials in light protection and iron levels in those vials
- Protecting drugs from light during administration, practical strategies to protect drug admixture from light
Description:
With the advent of different therapeutic protein modalities, photostability studies need to cover an increasing number of molecules with different physical and chemical properties. The results of such studies need to be interpreted emphasizing the following key points relevant to formulation design: (i) what are the photo-initiating events, (ii) what are the primary and secondary targets, (iii) what are the physical consequences for the protein modalities, and (iv) how can photo-degradation be mitigated. With regard to point (i), the questions are whether light directly interacts with the protein modality, e.g. an antibody drug conjugate (ADC), or whether photo-initiation involves excipients and/or impurities. These questions directly lead to point (ii), defining the targets for primary and secondary chemical conversions, and points (iii) and (iv), covering physical consequences and potential mitigation strategies. The second of the two webinars will focus specifically on (i) the role of transition metal impurities on protein photostability, (ii) the effect of glycosylation and protein domain-domain interactions on protein photostability, (iii) potential reactions of cobalamine-protein adducts, (iv) the effect of temperature, and (v) the pros and cons of potential mitigation strategies such as the use of colored vials and infusion bags.