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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

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

University of Chicago


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


Principles for biologic manufacturing
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


Facility
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


Process
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


Temperature Controlled COBE 2991

Chilled by Refrigerant Unit that also chills other equipment

cGMP, Co

University of Chicago


Temperature of bath and product

determines depth of immersion

cGMP, Co

University of Chicago


Bag being placed in heating

device made for the bag

cGMP, Co

University of Chicago


Bag being placed in cooling

device made for the bag

cGMP, Co

University of Chicago


Summary
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


Acknowledgments

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


Additional information
Additional Information

University of Chicago

Michael Millis, M.D.

773 702 – 6319

  • cGMP, Co.

    • Phil Lasarsky

    • 312 543-5523


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