ROBUST ANALYTICAL TECHNIQUES & PROCESSES FOR QUALITY ASSURANCE
Starting with incoming materials and progressing to finished products, we offer a comprehensive range of analytical services to ensure stringent quality assurance and the expertise to execute them with the highest level of precision and care. Doing otherwise is not an option — quality requirements for injectables are rigorous and, more importantly, our work has a direct impact on patients’ lives.
ADVANCED CHEMICAL, MICROBIOLOGICAL & STABILITY TESTING
Chemical testing at Simtra BioPharma Solutions spans raw materials and active pharmaceutical ingredients, equipment, materials in process, and finished and kitted products. Microbiological testing includes environmental monitoring of classified areas and personnel, sterility testing, in-process bioburden analysis, identification of microorganisms, stock culture maintenance and media release. We also conduct stability studies (follow-up, photostability, compatibility and qualification).
To perform analytical testing, we make use of chromatography and mass spectrometry, electrophoresis, spectroscopy, light scattering, ELISAs and other plate-based methods, elemental analysis and water content analysis.
Is Mannitol Hemihydrate Detrimental to Protein Stability Assessing Mannitol Crystallinity in Lyophilized Drug Products
Learn from the BioPharma Solutions team under what conditions MHH dehydrates and how the dehydration impacts protein stability.View resource
Importance of Assessing Mannitol Crystallinity in Lyophilized Drug Products
When mannitol is used as an excipient in a lyophilized drug product, assessing its crystallinity is important because drug product stability may be seriously compromised if mannitol completes crystallization during storage rather than during the freezing or annealing step in the lyophilization process.View resource
Vial Breakage During Lyophilization
Learn more from the BioPharma Solutions team on the Root Causes and Mitigation Strategy for Vial Breakage during Lyophilization.View resource