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Cellular Therapies Section Subsections

The Cellular Therapies Section has established subsections to allow members of the section to focus on particular areas of interest. All subsections will work on meeting the section charges, which involve developing educational programs, responding to questions posted on the CT Forum, and developing products and services to meet the needs of the field. The work will be accomplished primarily through conference calls and e-mail communication, managed by a subsection leader and assistant leader. Section participation is open to all AABB  individual members, who may enroll in multiple subsections. Click on a link below to read more about each Cellular Therapies Section Subsection.

Bone Marrow and Apheresis Collection
Cord Blood
Novel CT Therapies and Regenerative Medicine
CT Business Management
CT Clinical Practices
CT Product Assessment
CT Product Development and Tech Transfer
CT Product Manufacturing
CT Quality Operations
CT Regulatory Affairs

Bone Marrow and Apheresis Collection
The group would work on topics such as bone marrow and apheresis product collection and transport, new technologies for product collections, and mobilization of donors.

Cord Blood
This group would work on topics such as donor issues for public banking (recruitment, consent, screening/testing), manufacturing, storage and transport challenges, licensure, international issues, and private and family banking issues.

Novel CT Therapies and Regenerative Medicine
This group would work on topics such as ‘new’ science and preclinical studies related to CT product development (e.g. iPS cells, genetic engineering, etc.), CT products developed from tissue sources (e.g. pancreatic islets), biomaterials & structural materials, and new devices for manipulating cells.

CT Business Management
This group would work on topics such as reimbursement issues (CMS, FDA), funding sources for CT development and clinical trials - federal and other public sources, venture capital, charitable donations (disease advocacy groups), as well as the administrative business (for example, budgets, Human Resources) of CT production.

CT Clinical Practices
This group would work on topics such as donor and recipient clinical/screening/eligibility issues, informed consent, the use of cell therapy products in clinical trials, and product administration (infusions, adverse events).

CT Product Assessment
This group would work on topics such as product characterization, assay development, evaluation, and validation.

CT Product Development and Tech Transfer
This group would work on topics such as later-stage product development, validation, and technology transfer for clinical production.

CT Product Manufacturing
This group would work on technical topics such as cell separation and selection, cell expansion, automation, and cryopreservation.

CT Quality Operations
This group would work on topics such as Quality Program design, risk assessment and risk management, vendor and supply qualification, facility, environmental and operational controls.

CT Regulatory Affairs
This group would work on US and international topics such as regulations and guidance (for example, FDA, Health Canada, EMEA), OHRP regulations and guidance, NIH policies (for RAC, stem cell policies, etc), and HRSA regulations and policies. 

Cellular Therapies Section

Last modified on 11/17/2009 12:47:55 PM
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