Session Information
AABB Annual Meeting and TXPO 2009
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Product Stability and Storage: What Do I Really Have to Do?
Track
:
QE- Quality/Education
Program Code:
9130-QE-CT
Date:
Saturday, October 24, 2009
Time:
4:00 PM to 5:30 PM
EST
Location:
296
DIRECTOR
:
Doug Padley, MT(ASCP), Development Coordinator, Mayo Clinic
MODERATOR
:
Doug Padley, MT(ASCP), Development Coordinator, Mayo Clinic
SPEAKER
(S):
John D. McMannis, Ph.D., Director, Cell Therapy Laboratory, The University of Texas MD Anderson Cancer Center
Doug Padley, MT(ASCP), Development Coordinator, Mayo Clinic
Donna Regan, MT(ASCP)SBB, Executive Director, St. Louis Cord Blood Bank
Description
Stability programs are required for cellular therapy products; they are the basis for determining expiration dates.
This program will describe the regulatory requirements for stability programs for different types of products (351, 361, licensed) in addition to presenting factors to consider when developing a stability program. Beyond the regulations, product storage can present a challenge to the cellular therapy laboratory. Is there a preferred method for overnight storage of HPC, apheresis products? How do you know that the product frozen 10 years ago is suitable for transplant? How can you be assured that a cellular therapy product made under IND is stable for the duration of a clinical trial? These and other complexities of product storage will be discussed.
This program will describe the regulatory requirements for stability programs for different types of products (351, 361, licensed) in addition to presenting factors to consider when developing a stability program. Beyond the regulations, product storage can present a challenge to the cellular therapy laboratory. Is there a preferred method for overnight storage of HPC, apheresis products? How do you know that the product frozen 10 years ago is suitable for transplant? How can you be assured that a cellular therapy product made under IND is stable for the duration of a clinical trial? These and other complexities of product storage will be discussed.
- Describe the components of and the regulatory considerations for establishing a stability program for "351" and "361" products.
- Discuss considerations related to the use of cryopreserved products stored for extended periods.
- Discuss short-term storage of 'fresh' products.
| CE Category | CE Value |
|---|---|
| California Clinical Laboratory Personnel | 1.5 |
| California Nurse | 1.8 |
| Florida Laboratory Personnel | 1.8 |
| General Attendee | 1.5 |
| Physician | 1.5 |
Please note: Continuing education (CE) credit is available for online offerings only. Individuals that purchase CD-ROMs will not receive CE credit for the programs they view.
This session is a part of:
Online Access
(Code: 9130MA/9130NA/9130MN/9130NN)
Attendee/Member:$25 USD
Attendee:$40 USD
Member:$40 USD
$50 USD - Your Price
This session is a part of:
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