评估可推断出的 & leachables' role in ensuring the safety of cell and gene therapy product manufacture and long-term 存储.

尼克·莫理 深入研究 可提取和可浸出 testing for cell and gene therapy products in a concise, free-to-view, pre-recorded webinar. Discover the nuances of this critical testing through valuable cell and gene therapy insights, 基本注意事项, 以及产品安全和法规遵从的最佳实践.

溶剂和长期存放对E&L概要文件

This webinar offers invaluable insights and case studies showcasing the impact of solvents and long-term 存储 on extractable and leachable profiles. 它解决了冻结和解冻如何影响可浸出剖面, 展示存储条件如何影响可提取级别, 由现实生活中的例子和数据支持.

引导长期存储的监管格局

Discover the evolving regulatory landscape and the crucial need for detailed studies of materials used in the long-term 存储 of these transformative therapies. Uncover the significance of employing a methodical strategy that aligns with the principles of quality risk management.

对病人安全至关重要

The webinar is pertinent to professionals involved in  pharmaceuticals, 医疗设备, 监管事务, and quality control seeking a deeper understanding of extractable and leachable testing's impact on patient safety and regulatory compliance.

我为什么要看这个网络研讨会?

在本次网络研讨会中，Nick将探讨以下问题:

• The challenges faced in leachable risk assessment for revolutionary treatments.
• 设计和执行可提取 & leachable studies for disease treatment through advanced therapy medicinal products (ATMPs).
• How to navigate the evolving regulatory landscape for cell and gene therapy products in long-term 存储.

关键的细胞和基因治疗见解

• Introduction to Cell and Gene Therapy 产品s: We define and differentiate cell and gene therapy products, highlighting their disease-treating aim via the genetic material in live cells, 强调批处理大小的独特特性, 剂量, 存储, 设备, 管理方法.
• Understanding 可推断出的 and Leachables: The importance of assessing potential risks and impacts of 可提取和可浸出 in these products. 我们将介绍风险管理的系统方法, 识别可浸出物的潜在来源, 进行风险分析, 设计研究来解决知识差距.
• 案例研究:用于聚乙烯袋和聚四氟乙烯管等材料, we showcase how different solvents and conditions affect extractables. These studies highlight the importance of understanding solvent interactions and 存储 conditions to mitigate risks.
• Long-Term Storage Impact: The impact of freezing and thawing on leachable profiles, demonstrating how 存储 conditions could influence extractable levels, emphasizing the need for simulation studies to mimic real-world scenarios.
• Standards: The webinar stresses the importance of using a systematic approach aligned with quality risk management principles, 如ICH Q9中概述的. It also emphasizes leveraging existing standards like USP 87 and 88 for 生物al reactivity testing and USP 661 for plastic materials.

观看我们的细胞和基因治疗洞察网络研讨会

Take advantage of this chance to understand how extractable and leachable testing plays a vital role in securing the safety and effectiveness of cell and gene therapy products.
Access the webinar now to gain invaluable insights shared by industry expert 尼克·莫理.

如需查询或进一步信息，请直接与我们联系. We're here to address your concerns and guide you through this critical aspect of product development.

评估可推断出的 & leachables' role in ensuring the safety of cell and gene therapy product manufacture and long-term 存储 - Excerpt.

"Understanding the product and gathering as much information beforehand can determine knowledge gaps and guide appropriate studies, documenting the rationale for study design based on sound scientific justification is key."