CHARACTERIZATION AND DEVELOPMENT
Advancing biotherapeutic innovation with robust analytical and process solutions
Method Development
Our Method Development services are designed to create, optimize, and validate analytical techniques tailored to your specific biotherapeutic products. We utilize a rigorous, science-based approach to develop methods that are robust, reproducible, and compliant with regulatory standards. Whether you require novel assay formats or improvements on existing protocols, our expert team ensures that every method meets the critical parameters of sensitivity, accuracy, and precision essential for quality control and successful clinical translation.
Learn More About Method Development:
https://www.goprolytix.com/prolytix-services/method-development/
Process Development
Our Process Development services support the scale-up and optimization of your biotherapeutic manufacturing processes. By employing state-of-the-art technologies and comprehensive process analytics, we work closely with you to refine every step—from upstream production to downstream purification. Our goal is to streamline production workflows, minimize risks, and ensure consistent product quality while meeting all regulatory and commercial standards. This integrated approach accelerates product development and enhances overall efficiency.
Discover Process Development Solutions:
https://www.goprolytix.com/prolytix-services/process-development/
Protein Characterization Services
Our Protein Characterization Services provide a detailed analysis of the physicochemical and structural attributes of your biotherapeutic proteins. Through a combination of advanced analytical techniques—including mass spectrometry, chromatography, and electrophoresis—we evaluate protein purity, integrity, post-translational modifications, and biological activity. This comprehensive characterization not only ensures the safety and efficacy of your products but also supports regulatory submissions and enhances overall product development.
Explore Protein Characterization Services:
https://www.goprolytix.com/prolytix-services/protein-characterization-services/
Host Cell Protein Analysis
Our Host Cell Protein (HCP) Analysis services focus on the detection and quantification of residual proteins that can co-purify during biotherapeutic production. Utilizing highly sensitive and validated assays, we identify potential impurities that may impact product quality and patient safety. Our in-depth analysis aids in optimizing purification processes and ensures compliance with stringent regulatory guidelines, providing you with the confidence that your final product is both pure and safe for clinical use.
Learn More About HCP Analysis:
https://www.goprolytix.com/prolytix-services/host-cell-protein-analysis/