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PROCESS AND ANALYTICAL DEVELOPMENT

Clients choose BPTC because our extensive and comprehensive experience helps to accelerate their product development from Clone to Clinic to Commercial and minimizes associated technical and regulatory risks. Whether your product is in pre-clinical development, clinical trials, or ready for the market, we can help you:

  • Choose the optimal expression systems and ensure appropriate and judicious cell bank preparation and characterization and cell line development
  • Develop and optimize phase-appropriate manufacturing processes
  • Implement appropriate strategies, options, and decision matrices for the optimization and scale-up of your manufacturing processes, process validation, using a Quality by Design approach
  • Select, develop, qualify, and validate analytical methods for process development, product characterization, in-process and final product testing, and stability studies
  • Evaluate existing data and provide recommendations for drug product formulation, container/closure systems, and delivery systems
  • Establish and implement strategies for process changes throughout the product lifecycle, including preparing comparability protocols and reports as well as associated regulatory submissions
  • Prepare validation master plans, process validation protocols and reports, and viral safety studies

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