A stable formulation is critical to ensure the desired therapeutic activity and safety of biologics. Mechanical stresses during manufacturing and transportation and certain storage conditions can lead to protein destabilization and aggregation. By minimizing interface interactions and increasing solubility, surfactants can stabilize proteins. Polysorbates have been the most widely used surfactants in biologics due to their biocompatibility and low toxicity. However, over the past decade challenges associated with the stability of polysorbates have been encountered. To reduce these quality issues, alternative surfactants, such as poloxamer 188 are considered in biomolecule formulations.
In this webinar, you will learn:
- The role of surfactants as stabilizers in biopharmaceuticals
- The advantages/disadvantages of using the various marketed surfactant in biomolecule surfactants
- The impacts of impurities in excipients on the formulation stability
Speaker
Nelli Erwin, Ph.D.
Merck
Senior Manager, Head of Protein Stability
Nelli heads the protein stability laboratory in process and formulation materials - technology and innovation (T&I) at Merck. In this role, she is mainly responsible for the development of new technologies to improve the stability of biomolecule formulations. Her previous work experience includes a postdoc position in Analytical R&D at AbbVie. She holds a Ph.D. from the Technical University of Dortmund in Chemical Biology, investigating the structure and dynamics of biomolecules.
Pharma and biopharma manufacturing
- Solid Formulation Strategies
기간:58min
언어:English
세션 1:발표 완료 July 26, 2022
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