From assessment of microbial contamination, quality control testing, and shelf-life, our central focus on biological analytical services and product quality will guide your molecule’s success in commercial manufacturing at every step.
Our vision of a healthier world and dedication to our partner’s success inspires robust manufacturing methods supported by strong analytical development and services. Rigorous analytical and microbial testing of raw materials and manufactured products is crucial for a safe release. We have a highly skilled and knowledgeable Quality Control department on staff to guarantee compliance with all certificate of analysis requirements for both raw materials and finished goods.
Analytical methods identified as suitable for product critical quality attribute analysis during development are integral to assessing the overall quality of the molecule throughout manufacturing. At Cytovance, we offer an exciting combination of analytical expertise and state-of-the-art instrumentation to provide services designed to meet your program requirements and timelines. Our labs utilize cutting-edge methodologies for product characterization and sterility, including mass spectrometry (LC-MS), HPLC, protein content, process residuals, biological potency assays, detection of bacterial endotoxins, product sterility, and other compendial methods.
As your responsive CDMO partner, we focus on providing your team with the experienced advice and insightful data needed to make critical decisions and streamline efforts. As a result, a key aspect of our rigorous testing approach is timing. Quality testing that is phase-appropriate can reduce manufacturing costs and release timeframes while maintaining regulatory compliance.
