Stability Studies
A biotherapeutic stability testing study is a comprehensive assessment designed to evaluate how the quality, safety, and efficacy of a biotherapeutic product changes over time. Regulatory guidance documents, including the International Council for Harmonization (ICH) guidelines Q1A(R2) on stability testing and the U.S. Food and Drug Administration (FDA) guidelines, mandate such studies to standardize procedures and ensure that biotherapeutic products meet stringent quality standards throughout their lifecycle.
Stability Studies
A biotherapeutic stability testing study is a comprehensive assessment designed to evaluate how the quality, safety, and efficacy of a biotherapeutic product changes over time. Regulatory guidance documents, including the International Council for Harmonization (ICH) guidelines Q1A(R2) on stability testing and the U.S. Food and Drug Administration (FDA) guidelines, mandate such studies to standardize procedures and ensure that biotherapeutic products meet stringent quality standards throughout their lifecycle.
Our Expertise
Combining cutting-edge analytical methods and instrumentation, significant background in assay development and validation, with stringent GMP/GLP regulatory guidance and support, Avance scientists have the tools to successfully support your stability program to ensure precise and reliable assessment of the shelf-life, potency, and safety of your biotherapeutic product.
Avance Stability Testing
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Study Design:
Our Project Management will work with Customer to define the scope, objectives, and parameters of the study, including selecting the product batches, storage conditions, and duration of the study.
- Storage and Monitoring: Samples are stored in the defined controlled environment with 24/7 monitoring to ensure compliance with the study design.
- Analytical Testing: Testing is performed at the established time points to evaluate physical, biological, and microbiological attributes of the product. Common tests include potency assays, purity tests, and degradation product analysis.
- Documentation and Reporting: All procedures, observations, and results are documented in a comprehensive report.
Methods Supporting Stability Testing
Tests
Description
Custom assays based on ddPCR, QPCR, NGS, Flow cytometry, ELISA, etc
Assays designed for characterize client’s product for a specific feature
UV-Visible Spectroscopy (UV-Vis)
Concentration, purity, and detection of specific absorbance changes
Purity, MW, and/or Integrity analysis
Protein quantification
USP 71 Compendial Assay
USP 790 Compendial Assay (Visual Assessment)
USP 631 Color and Achromicity
pH stability and potential for degradation under different pH conditions
Osmolality, ensuring isotonicity and stability in biological conditions
