Experience.
Consistency.
Stability Testing Services by a Trusted US-Based CDMO
As a comprehensive US-based CDMO, GBI provides ICH-compliant stability testing services to ensure the quality, safety, and shelf life of drug substances and products throughout the biologic molecule’s development and manufacturing life-cycle. These studies are essential for clinical trial material and commercial readiness and support regulatory submissions across the U.S., Europe, Australia, Canada and Asia.
With decades of experience as a cGMP manufacturer, GBI partners with clients—from biotechs and medical institutions to global pharmaceutical firms—navigate the complex stability testing requirements for advanced biologics, including bioconjugates and antibody-based therapies.
Contact UsWhat Is Stability Testing?
Stability testing determines how environmental factors such as light, temperature, and humidity affect a drug’s quality over time. We support studies for both:
- APIs: The unformulated active pharmaceutical ingredient
- Drug substances and Drug products: The final formulated dosage, including excipients
Stability testing defines a re-test period for drug substances—the window during which the API remains within specification and can be used in manufacturing. Beyond this period, retesting and inspection are required before use or distribution.
GBI’s ICH-Compliant Stability Testing Capabilities
Our stability programs align with ICH Q1A(R2) guidelines (Stability Testing of New Drug Substances and Products), ensuring compliance across major regulatory bodies, including the FDA, EMA, and PMDA.
We offer studies under both long-term (real-time) and accelerated storage conditions:
Long-term storage options:
- 2 to 8°C
- -20 ± 5°C
- ≤ -65°C
Accelerated storage conditions:
- 25°C ± 2°C / 60% RH ± 5% RH
- 40°C ± 2°C / 75% RH ± 5% RH
For long-term testing, GBI follows standard ICH frequency guidelines:
- Every 3 months during the first year
- Annually after that, through the proposed shelf life (typically 36 months or more)
Integrated CDMO Services for Biologics Stability
Stability testing is a critical component of GBI’s full-service CDMO US offerings, supporting complex biologics from upstream processing and cell culture development through purification, formulation, and aseptic fill finish. Our stability studies are customized for each client and include:
- Protocol development
- Sample storage and monitoring
- Data analysis and reporting
- Regulatory-ready documentation
We generate product-specific protocols and stability reports to support global IND, NDA, and BLA submissions.
Supporting Complex Biologics and Bioconjugates
As a specialized cGMP manufacturer with deep experience in bioconjugates and antibody-based therapies, GBI is equipped to handle the nuanced stability needs of high-value biologics, bioconjugates including radiolabeled antibodies, and exosome-based therapeutics.
Partner with a Leading CDMO for Stability Testing
Whether part of a broader drug product development program or as a stand-alone service, GBI’s stability testing ensures that your materials meet regulatory standards and maintain integrity over time.
Contact us today to learn how our ICH-compliant stability testing can support your clinical or commercial strategy.
