Extractables and Leachables of Biopharmaceutical Container Closure Systems:
A Case Study by Pace Life Sciences (PLS)
Thursday, November 21, 2019
11am PST | 2pm EST
A Case Study by Pace Life Sciences (PLS)
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Overview
Biopharmaceutical drug product development is on the rise, and with it new regulations on packaging and container closure components associated with delivery of the drug product to the patient. PLS scientists will discuss relevant USP and ISO guidelines and practical considerations when planning an extractables and leachables project. PLS scientists will then present a case study demonstrating a typical extractables and leachables project, including the design, extraction, analysis and reporting of extractables and leachables data for typical single-use IV bags similar to those used for bioprocessing purposes. In the webinar you will learn about the extrables and leachables program at PLS, and how to get started analyzing the materials for your next project.
In this webinar you will learn:
Who should attend:
In this webinar you will learn:
- Results and analysis of an internal E&L case study of biopharmaceutical single use bag systems
- Overview of the process, procedures, and approaches for Biopharma E&L studies
- Analytical capabilities and expertise at Pace Life Sciences
Who should attend:
- Biopharmaceutical drug product and R&D scientists
- Compliance/regulatory/QA personnel
- Pharmaceutical drug product and R&D scientists
- Manufacturers/vendors/users of biopharma/pharmaceutical containers
Presenters
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