In this white paper, we introduce the purpose, scope, and type of stability testing required at each phase of product development. With this understanding, Sponsors can aim to optimize the process and ensure that the right data are gathered at the right time.
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Ensure comprehensive product analysis with Frontage’s team of experienced analytical scientists. We specialize in analytical method development, validation and transfer for product development and clinical trial materials (CTM) manufacturing support, as well as commercial product release and stability testing. Our services are designed to help sponsors throughout the drug development process in their effort to fully characterize drug substances, developmental formulations and commercial drug products.
Due to their size, nature, and biological origin, biologics or biopharmaceuticals are inherently complex in terms of quality attributes. Establishing and monitoring the quality attributes of a biologics is essential to ensure its efficacy and safety. Frontage offers the technical expertise and state-of-the-art instrumentation necessary for biologics characterization and analytical method development/validation. The biopharmaceuticals Frontage has supported include polysaccharides, fusion proteins, monoclonal antibodies, antibody drug conjugates (ADCs), vaccines, and gene therapy products.
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