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APMA 2008 CBER Reference/Sera Candidacy Testing

APMA 2008 CBER Reference/Sera Candidacy Testing. September 2008. James King. Agenda. Review of last years commitment to CBER Proposal for standardizing the optimization process for reference or sera replacement Proposal for summarizing reference replacement and unknown ERP data

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APMA 2008 CBER Reference/Sera Candidacy Testing

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  1. APMA 2008CBER Reference/Sera Candidacy Testing September 2008 James King

  2. Agenda • Review of last years commitment to CBER • Proposal for standardizing the optimization process for reference or sera replacement • Proposal for summarizing reference replacement and unknown ERP data • Discuss minimum aliquots required for proposed testing of reference or sera replacements

  3. APMA meeting October 2007 • Industry accepted the need to partner with CBER to provide quick and useful data for reference and sera replacement • Industry committed to have reference review to CBER in 30 days • Per the meeting minutes, CBER was going to supply industry with a standard method to supply results • CBER or Industry to standardize method for communicating reference/sera review

  4. To facilitate a unified collaboration between industry and CBER, HollisterStier Laboratories would like to propose: • A systematic approach to review new reference or sera • A means to report the data in a standardized format • Sharing data between industry and CBER

  5. Approach for replacement review • Optimization of assay parameters • Side by side testing of approved and proposed system

  6. Optimization • Goals: • Perform checkerboard optimization to achieve desired signal to noise. • Minimize consumption of CBER reference and sera. • Formalize a standard practice to communicate results to CBER.

  7. Optimization Proposal

  8. Example Checkerboard

  9. Performing CBER side by side testing • CBER distributes new reference • Two unknown samples are included • Third sample reserved for reference comparison • Samples tested on current system • Samples are tested on new optimized system

  10. Example of Results for submission to CBER and Industry

  11. HollisterStier will provide to those interested: • Spreadsheet for checkerboard optimization • Including fields for identifying selected conditions • Spreadsheet for side by side comparisons • Including automated calculation for percent difference or other statistical method as discussed by CBER and industry

  12. Needs from CBER • Provide enough of the proposed reference or sera to perform the testing as outlined in this slide show. • Approximately 500µL reference needed • Approximately 2 or 3 vials of sera • Provide unknown test samples for comparative testing • Communicate with industry when references are low so we can better adjust production

  13. In summary • This process is intended to: • expedite testing of proposed CBER reference or sera replacements • minimize impact to industry • summarize and share test results with industry in a standardized format • provide justification for accepting or rejecting reference or serum replacement • most importantly, allow us to work together

  14. Thank you for your time Remember to submit your yearly forecast of CBER reference and sera consumption to CBER by January 2009

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