Stability Testing
Understanding the stability of custom reagents is crucial for sensitive manufacturing processes and bioproduction runs. Unstable buffers can undergo pH drift, precipitation, or microbial growth, which may result in: variability in bioprocessing performance, batch failures and increased production costs, or delays in regulatory submissions. Validated stability data is essential to ensure GMP and FDA compliance while delivering consistent, reproducible results.
Stability Study Overview
Stability testing is a controlled study designed to establish, extend, or confirm the shelf life and efficacy of reagents over time. These studies may span several years and are conducted at predefined time points to monitor reagent integrity throughout and beyond its intended shelf life.
Stability testing can be performed as real-time or accelerated studies:
- Real-Time Stability Studies: Conducted under normal storage conditions, beginning at T0 (baseline) and continuing at scheduled intervals such as midpoint (T1/2), shelf life (T1), and beyond (e.g., T11/2). Post-shelf-life testing helps determine whether expiration dates can be extended.
- Accelerated Stability Studies: Performed under controlled temperature and humidity to speed up reagent aging, providing faster results. Long-term stability under normal conditions is predicted using the Arrhenius equation.
Accelerated studies are especially useful for process validation, new reagent qualification, and regulatory submissions.
Testing intervals can be expressed as fractions of shelf life (T1/2, T11/2) or as defined time periods (e.g., monthly).
Stability Studies at Boston BioProducts
Boston BioProducts offers customizable stability studies to support buffers, reagents, and solutions for both research and manufacturing applications. Study durations can range from weeks to years and can be tailored to meet specific product and regulatory requirements. Stability testing can be integrated with our in-house manufactured reagents or performed independently for third-party products.
Our services include:
- Custom study design aligned with product specifications and regulatory guidelines
- Integrated manufacturing and testing for in-house or external reagents
- Regulatory compliance and documentation support for GMP and FDA submissions
- Shelf-life confirmation and extension analysis
We provide comprehensive analytical and bioanalytical testing as part of our stability studies.
What test is used at Boston BioProducts?
Build a Custom Reagent Quickly
- Appearance
- pH, USP <791>
- Conductivity, USP <644>
- Osmolality, USP <785>
- Refractive Index, USP <831>
- Viscosity, USP <914>
- Density, USP <841>
- Absorbance
- Bacterial Endotoxin, USP <85> / USP <86>
- RNase Activity
- DNase Activity
- Protease Activity
- Microbial Growth
- Bioburden, USP <61>
- Sterility, USP <71>
| Considerations and Limitations of Stability Studies | |
|---|---|
| Scope of Study | Define whether the goal is shelf-life confirmation, extension, or regulatory submission before starting. This determines study length, testing intervals, and required data. |
| Real-Time vs. Accelerated | Real-time studies reflect actual storage conditions, while accelerated studies provide quicker data but require specialized equipment and predictive modeling. |
| Testing Selection | All analytical and bioanalytical tests must be defined before starting the study to ensure meaningful and consistent results. |
| Regulatory Requirements | Consider GMP, FDA, or global regulatory expectations when defining study design and documentation requirements. |
Plan Your Stability Study
Ensure consistent buffer and reagent performance with Boston BioProducts' stability testing services. We offer real-time and accelerated stability studies designed to confirm shelf life, extend reagent use periods, and maintain process reliability in bioproduction, life science research, and GMP manufacturing.
Our technical team can help you design a stability program based on your process requirements, regulatory needs, and timelines.
Contact us today to learn how Boston BioProducts can support your stability testing needs.