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AccutaseGMP
GMP Cell Detachment Solution
 AccutaseGMP is a ready to use non-mammalian, non-bacterial replacement for all applications of Accutase where GMP grade is necessary.  It is formulated to perform the same as Accutase on cell detachment yet provide the user with the reassurance associated with GMP manufacturing protocols under our ISO13485:2106 certified quality management system.  AccutaseGMP has undergone 20nM (nano meter) viral filtration and is tested for USP <71> sterility and USP <81> Endotoxins.  It does not contain mammalian or bacterial derived components.  AccutaseGMP is not intended for diagnostic or therapeutic use.  
Advantages of AccutaseGMP
  • Gentle on Cells
  • Increased cell viability
  • Fewer steps for cell passaging
  • Non-mammalian, non-bacterial
  • Maintenance of cell surface markers
  • Harmonized documentation package including:
    • Certificate of Analysis
    • Certificate of Origin
    • BSE/TSE statement
    • Statement of Product Stability
    • Authorization letters for our Drug Master File, as appropriate​
​Applications 
  • Research and Development
  • Cell and Gene Therapy product manufacturing
  • Bioreactors
  • Cell manufacturing
  • Tissue-based product manufacturing
​Looking to try before you buy? Request a FREE Sample!

Pricing

AccutaseGMP - 100 ml - $120 each
Cat# AT107-100mL
AccutaseGMP - 500ml - $480 each
Cat# AT107-500mL
AccutaseGMP - 10L Bag - PO and minimum order quantity required

Quality System and Quality Standards

  • Our Quality Management System is certified to ISO13485:2016
  • The Quality management System is managed with Qualcy eQMS for electronic Document Change Control, integrated Employee Training Records, CAPA and Quality Audit Management, Equipment Maintenance and monitoring records.
  • Quality Management records are maintained to assure full traceability and lot to lot consistency.
  • This facility uses dedicated equipment and machinery to prevent cross contamination.

Documentation

Go to our documentation page to view and download a sample Certificate of Analysis, Certificate of Origin, and more!

Questions?  Give us a call!  858.587.1716 or
Check out our FAQ Page!

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