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ISLET TRANSPLANTATION: FOCUS ON MANUFACTURING

ISLET TRANSPLANTATION: FOCUS ON MANUFACTURING. Michael Millis, M.D. UNIVERSITY OF CHICAGO AND cGMP, Co. GOAL. Develop a Islet Transplant Program that would withstand the anticipated regulatory requirements Practical for an academic institution’s financial constraints. cGMP, Co.

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ISLET TRANSPLANTATION: FOCUS ON MANUFACTURING

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  1. ISLET TRANSPLANTATION:FOCUS ON MANUFACTURING Michael Millis, M.D. UNIVERSITY OF CHICAGO AND cGMP, Co.

  2. GOAL • Develop a Islet Transplant Program that would withstand the anticipated regulatory requirements • Practical for an academic institution’s financial constraints cGMP, Co University of Chicago

  3. cGMP, Co • Procedure that encompasses • cGMP for the manufacture of • biologics • BLA ready • Reimbursable • Standard Laboratory Practice • 2000 Reminder letter that FDA • regulates Islet Transplantation • 3/02 Guidance regarding validation • of processing human tissues for • transplantation cGMP, Co University of Chicago

  4. Principles for Biologic Manufacturing • Control and Validation of • Facility • Process • Goal: Make cellular (Islet) isolation conform to the Principles of Biologic Manufacturing cGMP, Co University of Chicago

  5. Facility • Early planning matching existing institutional assets with anticipated regulatory compliance- form a good plan • Define robust process that when modified does not effect integrity of facility (validated) • Early planning to control costs cGMP, Co University of Chicago

  6. Process • Control the critical process environment to assure product safety and repeatability • Temperature • Bio-burden • Cross-contamination • Eliminate all equipment that cannot be validated to assure absence of contamination/cross contamination • Eliminate all components that require the use of undesirable substrates • Early training of staff to assure aseptic transfer of product (SOPs, training, QA/QC) cGMP, Co University of Chicago

  7. Temperature Controlled COBE 2991 Chilled by Refrigerant Unit that also chills other equipment cGMP, Co University of Chicago

  8. Temperature of bath and product determines depth of immersion cGMP, Co University of Chicago

  9. Bag being placed in heating device made for the bag cGMP, Co University of Chicago

  10. Bag being placed in cooling device made for the bag cGMP, Co University of Chicago

  11. Summary • Islet Isolation can be performed under conditions that adhere to BLA requirements • It requires expertise in pharmaceutical standards for laboratory and process development cGMP, Co University of Chicago

  12. Jonathan Lakey Camillo Ricordi Benhard Hering James Shapiro State of Illinois Tom Cross JDRF University of Chicago Diane Ostrega Marc Garfinkle Technicians cGMP, Co. Phil Lasarsky John Jarosz Gambro/COBE Acknowledgments

  13. Additional Information University of Chicago Michael Millis, M.D. 773 702 – 6319 • cGMP, Co. • Phil Lasarsky • 312 543-5523

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