Stability Testing of Biological Products
Overview:
Stability Testing of Biological Products is essential for evaluating how biologics—such as vaccines, antibodies, enzymes, cell-based therapies, and recombinant proteins—respond to various environmental conditions over time. This testing ensures that the product maintains its safety, potency, purity, and efficacy throughout its shelf-life.
Test Description:
Biological samples are stored under controlled temperature, humidity, and light conditions, and tested at scheduled intervals for physicochemical, biological, and microbiological stability. Both real-time and accelerated stability studies are performed in line with international guidelines.
Purpose & Benefits:
- Determine shelf-life and establish expiry dates
- Validate label storage conditions (e.g., “store at 2–8°C”)
- Identify degradation pathways and formulation robustness
- Meet regulatory requirements for market approval and quality assurance
Industries Served:
- Biopharmaceuticals
- Vaccines & Immunotherapies
- Cell & Gene Therapies
- Clinical Trials & R&D
- Biosimilar and Biologic Product Manufacturers
- Dissolution Testing – Drug Release Profiling
- Shelf-Life Testing – Stability & Expiry Determination
- Assay of Residual Solvents – Volatile Impurity Analysis
- Sterility Testing – Assurance of Microbial Purity
- Potency Testing – Verifying Therapeutic Efficacy
- Disintegration Testing – Ensuring Effective Drug Release
- Fungal and Bacterial Contamination Testing
- Heavy Metal Testing – Ensuring Product Safety & Regulatory Compliance
- pH Testing – Ensuring Product Stability, Safety, and Compliance
- Moisture Content Testing – Ensuring Stability, Efficacy, and Shelf-Life of Drug Products