Stability studies (R&D, GMP)
Safeguard the development and manufacturing of your products with our comprehensive stability studies.
Why are stability studies important?
Stability studies provide critical information about the stability and shelf life of drug products. These studies help ensure that drug products remain safe, effective and meet the quality standards throughout their entire shelf life.
- Product shelf life determination: Help to determine the appropriate shelf life of your drug products
- Product quality assurance: Assessment of physical, chemical and biological properties of your drug products over time under various environmental conditions, such as temperature, humidity and light exposure. Ensure that your products maintain their intended potency, efficacy and safety throughout their shelf life
- Regulatory compliance: Regulatory authorities require stability studies as a part of the approval process. These studies provide evidence to support the expiration dates and storage conditions stated on the drug labels
- Safety: By understanding the stability profile of your drug products, you can minimize the risk of adverse effects and protect patients from consuming degraded or ineffective medications
- Post-approval monitoring: Stability studies continue even after a drug product is approved for market. Ongoing stability monitoring helps you detect any changes in the stability profile over time or due to environmental factors. This monitoring ensures the continued safety and efficacy of your drug products throughout their lifecycle
Understanding our stability studies capabilities
We can support you at R&D stage and GMP manufacturing with our stability studies, including:
- Real-time stability (long term)
- Accelerated stability
- Stress stability (forced degradation)
- Photostability as per ICH Q1B
- In-use stability study
These stability studies are fully controlled and monitored (24hr/7days), with comprehensive documentation produced.
GMP stability studies are completed under a variety of conditions and we have the facilities and chambers to hold different temperature and humidity conditions.
- Cooling chambers (2-8°C)
- Deep Freezers (-20°C)
- Ultra-low temperature freezers (-80°C)
- Humidity chambers (25°C to 40°C)
Why partner with Enzene?
We are a global Continuously Innovative Development and Manufacturing Organization (CIDMO), dedicated to changing the paradigm by which affordable biologic and biosimilar medicines are brought to market. Since Enzene’s inception, our innovative agility has enabled us to continually introduce transformative processes in biologics manufacturing that significantly increase product yields of complex biologics and monoclonal antibodies (mAbs) while reducing the manufacturing footprint and the cost of production.
Game-changing innovation is only the beginning, though. We are Enzene, and that means that our values of innovation, entrepreneurship, respect, candor, excellence, and integrity underscore everything we do from project management and communications to teamwork and ideation. To us, true partnership is about driving biotech innovation while doing so in a way that develops long-lasting trusted partnerships.
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The future begins now
Your biologic deserves the most technologically advanced manufacturing process in the industry. And you deserve a new way to think about strategic partnership. Today is just the beginning.