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PROCESS & ANALYTICAL DEVELOPMENT

You choose BPTC because our extensive and comprehensive experience in process and analytical development will accelerate your product development from Clone to Clinic to Commercial™ and help minimize associated technical and regulatory risks. Whether your product is in pre-clinical development, clinical trials, or already for the market, we can assist 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
  • Develop and optimize phase-appropriate manufacturing processes
  • Prepare validation master plans, process validation protocols and reports, viral safety studies

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