Ensuring Quality and Compliance for Your Biotherapeutic Products

GMP Stability Testing & Storage

Our GMP Stability Testing & Storage services provide a comprehensive evaluation of your product’s stability profile over its intended shelf-life. By simulating real-world conditions and stress testing under accelerated protocols, our state-of-the-art facilities ensure that your products maintain their integrity, efficacy, and safety throughout storage. We monitor key parameters including temperature, humidity, and light exposure, using validated methods and a robust quality management system to ensure complete compliance with cGMP and FDA guidelines. In addition, our secure storage solutions are designed to preserve product quality, giving you confidence in your biotherapeutic product’s lifecycle.

Learn More About GMP Stability Testing & Storage:
https://www.goprolytix.com/prolytix-services/gmp-stability-testing-and-storage/

GMP Release Testing

Our GMP Release Testing services are integral to ensuring that every final product batch meets the stringent quality and regulatory standards required for market entry. Using a range of validated analytical methods, our expert team conducts thorough testing to verify that all critical quality attributes—including purity, potency, and safety—are within specification. Each test is meticulously documented and reviewed as part of a comprehensive quality assurance process, ensuring that every release decision is backed by reliable data. This rigorous testing protocol not only satisfies regulatory requirements but also builds trust in your biotherapeutic product, assuring stakeholders and end-users alike.

Discover Our GMP Release Testing Services:
https://www.goprolytix.com/prolytix-services/gmp-release-testing/