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Pharma Stability: Insights, Guidelines, and Expertise

Tag: mAb stability study design

Stability Protocol Design for Monoclonal Antibodies

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Stability Protocol Design for Monoclonal Antibodies Designing Stability Protocols for Monoclonal Antibodies: Regulatory and Scientific Best Practices Monoclonal antibodies (mAbs) are among the most complex and sensitive drug products in the biopharmaceutical landscape. Their large molecular structure, post-translational modifications, and susceptibility to environmental stress make stability protocol design a critical component of product development and…

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  • Maintain Backup Stability Chambers to Prevent Data Loss in Case of Failure

    Understanding the Tip: Why backup chambers are essential: Stability chambers are critical infrastructure in pharmaceutical QA.
    A sudden malfunction—due to power failure, temperature controller breakdown,… Read more

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