History: In late 2005, ISCT’s Laboratory Practices Committee (LPC) identified defining recommendations for microbiology test method validation as one of its goals. This effort was led by Lynn O’Donnell and Andy Walton. The LPC reviewed several validations from cell processing facilities and developed a list of issues to be taken to a larger group of stakeholders in order to develop a consensus. ISCT has committed to forming and supporting a Microbial Testing Working Group (MTWG) to address this issue. The MTWG represents a collaborative effort with representation from AABB and ASFA. The MTWG held an initial meeting at the Somatic Cell Therapy Meeting in September 2006 and will continue to meet by teleconference as needed.
Working Group’s Mission Statement: The Microbial Testing Working Group is dedicated to defining and recommending the necessary elements and a sample protocol for verification of microbial test methods for 361 HCT/Ps. In addition, considerations will be defined for validation studies of early phase 351 HCT/Ps utilizing alternative sterility test methods (i.e., other than compendial USP/CFR methods). The Group is comprised of cell therapy professionals from industry and academia. The Group will fulfill its mission by utilizing a representative core group of members that seek the advice of a larger Advisory Group. The main deliverable for the MTWG is a white paper outlining the recommendations, which will be submitted to FDA for consideration and published in a scientific journal.
Core Group: Core Group members are committed, have the required expertise, and are representative of a range of identified stakeholders. The Core Group is charged with producing a draft document, soliciting input from the Advisory Group and producing the final white paper.
Core Group Chair:
Lynn O’Donnell, PhD
Columbus, OH
Core Group Members:
Ellen Areman, MS, SBB (ASCP)
Glen Burnie, MD
Karen Edward, BS, MT (ASCP)
Seattle, WA
Diane Kadidlo, MT (ASCP), SBB
St. Paul, MN
Hanh Khuu, MD
Bethesda, MD
Kathy Loper, MHS, MT (ASCP)
Bethesda, MD
Andy Walton, MT (ASCP), SBB
Orange, CA
Advisory Group: Advisory Group members are committed, have the required expertise, and are widely representative of the spectrum of identified stakeholders. The Advisory Group is charged with providing expertise outside that of the Core Group, reviewing documents, and providing input at critical stages.
Advisory Group Members:
J. Wade Atkins, MS, MT (ASCP), SBB
Bethesda, MD
Anne Barnes
Durham, NC
Mark Brecher, MD
Chapel Hill, NC
Lizbeth Cardwell, MT (ASCP), MBA
Seattle, WA
Lizette Caballero, BSc, MT
Orlando, FL
Janice Davis-Sproul, MAS, MT (ASCP)
Baltimore, MD
Gary du Moulin, PhD
Cambridge, MA
Paul Eldridge, PhD
Memphis, TN
Dennis Gastineau, MD, FACP
Rochester, MN
Julie Gruber-Allickson, MS, MT (ASCP)
Oldsmar, FL
Shelly Heimfeld, PhD
Seattle, WA
John McMannis, PhD
Houston, Tx
Elizabeth J. Read, MD, PhD
Bethesda, MD
Horacio Rilo, MD
Cincinnati, OH
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