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Autoinjector Drug Products

A Comprehensive Guide to Functional, E&L, CCIT, and Stability Testing in NIS-AUTO

Autoinjectors

What you will learn

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Critical Testing Strategies

Gain insights into the essential testing requirements for automated needle-based injection systems, including functional testing, extractables and leachables (E&L), container closure integrity testing (CCIT), and stability testing, ensuring safety, efficacy, and regulatory compliance.

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Overcoming Development Challenges

Understand the unique formulation challenges of high-concentration biologics, including viscosity, aggregation, and the need for tailored excipients, to optimize product stability and performance under real-world conditions

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Regulatory Landscape and Best Practice

Learn about the latest industry standards like ISO 11608, USP guidelines, and the evolving regulatory landscape, ensuring your autoinjector products are ready for global market success.