New Viral Clearance Facility Now Open

Mar 11 2013

Charles River is proud to announce the opening of our new Great Valley Viral Clearance Facility in King of Prussia, PA, USA. This purpose-built facility is supported by our team of study directors who work with clients from development of scale-down procedures to submission of studies to regulatory agencies. The extensive experience of our study directors, together with our database of over 2,000 studies, makes us the optimal partner for viral clearance work.

The new site is 24,000 square feet (2,230 square meters) and is equipped with dedicated client laboratories containing fully qualified ÄKTAexplorer/purifier chromatography systems. The facility contains both cell culture and virus production laboratories to ensure quick and easy access to cells and virus stocks for studies. For convenience, clients will have access to a private office with internet access during study execution.

It is the goal of our expert study directors to help guide clients through the process of study planning, execution and submission of data to regulatory bodies. In order to do this, our new facility offers the following support services:

  • Regulatory consultation in study planning (Europe, US, Japan)
  • Support in downscaling/establishment of laboratory scales
  • Selection of process steps
  • Selection of viruses
  • Optimization of viral clearance study design(s)
  • Charles River personnel available to perform all process steps
  • Interpretation of results and help with troubleshooting
  • Comprehensive and flexible reporting
  • Expert statements/support in virus risk assessment
  • Accompanied agency visits (at the agency or during audits)
  • Seminars and training at client sites
  • myBPS℠ customer portal for rapid document exchange and communication
  • Dedicated project management to ensure smooth communications and on-time delivery of projects

Our global client base will also benefit from the Great Valley site’s harmonized procedures with our Cologne, Germany viral clearance site. This harmonization allows for easy transfer or performance of studies at either location. For further information about Charles River’s viral clearance services please contact us at askcharlesriver@crl.com.

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