Western Biotech, LLC
consulting to accelerate product development
Western biotech is a consulting company that helps customers to accelerate product development and reduce costs by providing outsourced services.

Our expertise

Technical

  • Bioanalytical methods development
  • Manufacturing process development including:
    • DNA-free processes
    • Protein expression and purification
    • Antibody purification
    • Cell culture optimization and scale up
    • Viral vectors
    • System integration
  • In-vitro diagnostic devices:
    • methods development
    • manufacturing process development
    • Integration of chemical, biological and engineering components

Quality Management Systems

  • Method and process development under US FDA QMS and ISO 13485
  • Method validation
    • Validation protocol development
    • Statistical data analysis
    • Following appropriate CLSI and ICH guidelines

Business

  • Financial modelling, especially process and product modeling to develop optimal strategy and forecasting
  • Development of process, product and organizational metrics and systems to drive improved performance

Contact us:

please email sdryga "at" westernbiotech.us with inquiries.