Traditional extractables and leachables (E&L) assessment approaches developed for monoclonal antibodies may not fully address the specific risks and testing needs of emerging modalities. Applying conventional protocols without considering modality-specific characteristics and development stage can lead to unnecessary testing or gaps in safety assessment.
This whitepaper explores how Samsung Biologics’ MSAT experts, Harim Kim and Yeonjeong Choi, approach E&L assessment for new modalities through a pragmatic, phase-appropriate framework designed to balance patient safety with development efficiency.
Key highlights include:
Why E&L assessment strategies need to be tailored to new modalities
Phase-appropriate E&L testing from development through launch
Samsung Biologics’ E&L testing protocols and practical case studies
Discover how a phase-appropriate E&L framework can support patient safety while aligning testing strategies with the needs of new modality development.
Traditional extractables and leachables (E&L) assessment approaches developed for monoclonal antibodies may not fully address the specific risks and testing needs of emerging modalities. Applying conventional protocols without considering modality-specific characteristics and development stage can lead to unnecessary testing or gaps in safety assessment.
This whitepaper explores how Samsung Biologics’ MSAT experts, Harim Kim and Yeonjeong Choi, approach E&L assessment for new modalities through a pragmatic, phase-appropriate framework designed to balance patient safety with development efficiency.
Key highlights include:
- Why E&L assessment strategies need to be tailored to new modalities
- Phase-appropriate E&L testing from development through launch
- Samsung Biologics’ E&L testing protocols and practical case studies
Discover how a phase-appropriate E&L framework can support patient safety while aligning testing strategies with the needs of new modality development.
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