Course Description:
As part of USPs work to strengthen the Polysorbate monographs, the USP Excipients Expert Committee is evaluating technologies and methods while working with manufacturers and users of polysorbates to Understand the Composition and Quality of Polysorbates. With increased demands from stakeholders to USP to update and establish clear specifications for characterization of different polysorbate(s) (PS) compositions used in pharmaceutical development and manufacturing, USP Excipients Expert Committee proposes to revise the PS monographs by including a direct method of analysis to better understand the PS compositions and their impact on the quality of pharmaceutical drug products (including PS used for therapeutic biological drug products). A Stimuli article to be published in PF 47(1) provides the EXC EC’s current understanding of PS compositions, opportunities faced in strengthening the PS compendial standards. A survey associated with the Stimuli article was created to help gather additional stakeholder feedback to help the EXC EC understand their needs and engage further support for the PS monograph modernization. This presentation will highlight the reasons why PS are among the most versatile surfactants in pharmaceutical use, USP efforts to overcome the deficiencies in current knowledge on PS products, by working with industry experts toward developing a suitable direct test procedure to analyze PS composition in the investigation of PS products. This presentation discusses USP efforts in the characterization and understanding of PS that have occurred within the past few years, the current progress and challenges in developing a direct analysis procedure to better understand the composition of PS and their impact on the quality of pharmaceutical and therapeutic biological products.
The live version of this recording took place on April 12, 2021 and features
a presentation by Richard Cawthorne, Ph.D. and Dominic Moore, B.Sc.
Who should participate:
- Analytical chemists
- QA/QC analysts
- R&D scientists, managers
- Team members in CMC development projects
- Manufacturing scientists, managers
- Regulatory affairs specialists
- Contract research organizations
- Contract manufacturing organizations
Access Duration:Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.