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Laboratory

Agile BioScience: Understanding Degradation Pathways for Optimal Biopharmaceutical Stability

Forced degradation studies

Forced degradation studies are essential for characterizing potential degradation pathways of your biopharmaceutical product under various stress conditions. Agile BioScience offers comprehensive forced degradation studies to ensure product stability and inform formulation and storage strategies.

Why Forced Degradation Studies Matter:

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  • Identify Degradation Products: Exposing your product to stressful conditions reveals potential degradation pathways and likely breakdown products.

  • Optimize Stability: Understanding vulnerabilities allows informed formulation and storage decisions to maximize shelf-life.

  • Regulatory Compliance: Meet ICH guidelines (Q1A, Q1B, Q2B) and demonstrate a commitment to quality and stability assessment.

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Our Forced Degradation Expertise:

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  • Advanced Analytical Techniques: Our suite of analytical tools enables sensitive detection and identification of degradation products.

  • Stability-Indicating Methods: We develop assays specifically designed to separate and quantify your product and its degradation products.

  • Data-Driven Guidance: We interpret results to identify key degradation pathways and make recommendations to enhance stability.

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Benefits of Choosing Agile BioScience:

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  • Proactive Stability Management: Anticipate and address potential stability issues early in product development.

  • Confidence in Quality: Ensure your product maintains its quality, safety, and efficacy throughout its shelf life.

  • Regulatory Readiness: Generate robust stability data supporting your regulatory submissions.

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Contact us to learn how our forced degradation studies can optimize the stability of your biopharmaceutical.

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