Stability Testing & Quality Excellence: A Robust Foundation for Pharmaceutical Development and Commercial Manufacturing
Supporting Pharmaceutical Development Through Stability Testing
Stability studies play an important role in pharmaceutical development and manufacturing, helping assess how active pharmaceutical ingredients (APIs) behave under different environmental conditions. A well-equipped stability laboratory provides the testing capabilities needed to support these studies and strengthen analytical support throughout development.
At Asymchem’s Sandwich Site, the API stability laboratory supports a range of testing and storage requirements, including photostability, temperature and humidity testing, and −30°C freezer storage. Equipment is monitored through the Eurotherm system, with equipment qualification and temperature mapping performed by Valcomm.
Together, these capabilities provide a controlled and monitored environment for stability studies, strengthening the site’s analytical capabilities and supporting pharmaceutical development and manufacturing activities.
Quality and Compliance at the Core of Manufacturing Readiness
At Sandwich Site, the Quality Management System (QMS) is ready to support first commercial production and process validation, while preparations for commercial product manufacturing and release have been completed. The site successfully completed an MHRA cGMP audit in November 2025 with no Critical or Major findings, and all corrective and preventive actions (CAPAs) have been closed.
The site holds MHRA certification (UK API 61246), which is recognized by multiple major markets, including the US, EU, and Japan. It has also passed a Pharmaceutical Supply Chain Initiative (PSCI) external audit with only minor findings and obtained ISO 14001 Environmental Management System certification.
These credentials and quality systems reflect the site's commitment to maintaining high standards of quality, compliance, and environmental management, while supporting its readiness for commercial manufacturing and supply.
Supporting Customers from Development to Commercial Supply
Stability testing capabilities, established quality systems, and commercial manufacturing readiness work together to support pharmaceutical programs as they progress toward manufacturing and supply. By combining analytical capabilities with a strong foundation in quality and compliance, Asymchem’s Sandwich Site is positioned to support customers’ innovative drug development and manufacturing needs.
Through its continued focus on analytical capability, regulatory compliance, and manufacturing readiness, Sandwich Site strengthens Asymchem’s ability to provide global customers with dependable support for pharmaceutical development and commercial supply.
