Viral Clearance Study Request

Note:  Please complete the form in as much detail as possible to expedite the generation of your Statement of Work.
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Yes, I would like to receive email communications from Charles River and allow for my information to be used for any follow-up requests to identify potential products or services relevant to my needs.

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General Information
Country of Submission


 
Have you already performed viral clearance studies for this product?

 
Development Phase  
Quality Standard

 
What is the deadline for the final report?   
When will process material be available for pretest? 
Please note: Pre-testing takes roughly 4 weeks and must be completed prior to performance of the main process steps. CRL requires 2 aliquots of roughly 10mL each for each of your process materials. These aliquots are needed at a minimum 4 weeks prior to scheduled date for main process step performance.
 
When will process material be available for spiking study?   
Comments / notes  

Product Information
Product Name  
Product Category  
Production cell line (CHO, PERC6, HeLa,etc.)  
Recombinant Type (mAb, recombinant protein, etc.)  
Plasma product Type (coagulation factor albumin, etc.)  
Description of component/type of medical device   
Tissue source (porcine, bovine, etc.)  
Tissue type (liver, kidney, cartilage)  
Constitution of process material used for “spiking” (i.e. fluid or solid (tissue) or a mix of both)  
Tissue source (human, porcine, bovine, etc.)  
Tissue type (liver, kidney, cartilage)  
Product type (heparin, cytokine, hormone, etc.)  
Constitution of process material used for “spiking” (i.e. fluid or solid (tissue) or a mix of both)  
Vector Type (e.g. AAV, lentivirus, etc.)  
Production system (please specify vector production system like cell line used; helper virus; helper virus production system, critical raw materials used, etc.  
Description  

Process Steps
   Low pH treatment 3.5 to 4.0  
   Detergent treatment    
No. of Other Inactivation intended to be analyzed
Select # for different "other" inactivation steps
   Other inactivation    
   Virus Retentive Filtration    
No. of chromatography intended to be analyzed    
   Chromatography (including Membrane Adsorber)