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Biologics Testing Solutions

The approval process for ensuring the identity, potency, purity, safety and effectiveness of a biopharmaceutical is complex, but its effective navigation is critical to the ultimate commercial success of your product. With more than 50 years of experience, Charles River Biologics Testing Solutions has the proven knowledge, expertise and capacity to address challenging projects from biotechnology and pharmaceutical companies worldwide. We provide tailored global testing and manufacturing services to help accelerate drug development from concept to product release. Our primary emphasis is on quality, which is enforced through continuous training and internal audit programs, ensuring that our practices are in compliance with global regulatory guidelines. We support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. We have the capabilities to address the needs of companies based anywhere in the world. Our facilities in the US, UK, Ireland and Germany are part of a global scientific network, offering services that span the entire drug development process. This allows us to provide with more flexibility, experience and expertise to maximize resources and optimize results based on your specific program needs.

Area of Expertise Include

  • Cell Banking and Characterization
  • Product Characterization
  • Impurity Testing
  • Viral Clearance Studies
  • Lot Release Testing
  • Stability Testing
  • In Vivo Biosafety
  • In Vivo and In Vitro Potency Testing
  • Vaccine Challenge Studies
  • Polyclonal Antisera Production
  • Discovery and Development
  • Vaccine Support
  • Biosimilar Testing
  • Consulting and Project Management

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