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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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