Elsevier

Cytotherapy

Cell and gene therapy products

The The states Pharmacopeia (USP), the USP Biotechnology and Factor Therapy Subcommittee, and its Advisory Panel on Gene and Prison cell Therapies accept prepared the following typhoon chapter on 'Cell and Gene Therapy Products', This chapter has been proposed in USP'due south Pharmacopeia! Forum (January—February 2000) as an advisory chapter to provide guidance to interested parties. USP is requesting comments on the proposed chapter from individuals, organizations, and companies. The Adept Subcommittee volition consider and comprise these comments in the final draft, as advisable. All comments may be sent to Dr Roger Dabbah, Associate Director, Partitioning of Biologies and Biotechnology, USP, 12601 Twinbrook Parkway, Rockville, Maryland 20852 (due east-mail: [e-mail protected]).

Abbreviations

AABB

American Association of Claret Banks

7-AAD

7-amino-actinomycin D

AATB

American Association of Tissue Banks

AAV

adeno-associated virus

BSE

bovine spongiform encephalopathy (mad cow disease)

CBER

FDA Center for Biologics Evaluation and Inquiry

CDC

The Centers for Disease Command and Prevention

CDER

FDA Centre for Drug Evaluation and Research

CGMP

current adept manufacturing exercise

CSF

colony-stimulating factor

ELISA

enzyme-linked immunosorbent analysis

FACS

fluorescence-activated jail cell sorter

GM-CSF

granulocyte-macrophage colony-stimulating gene

GVHD

graft versus host affliction

HLA

human leukocyte antigen

HRSA

Health Research Services Administration

NIH

National Institutes of Health

NMDR

National Marrow Donor Registry

PBPC

peripheral claret progenitor cell

PCR

polymerase chain reaction

QC-QA

quality control-quality assurance

RCA

replication-competent adenovirus

RCR

replication-competent retrovirus

RCV

replication-competent virus

SDS-PAGE

sodium dodecyl sulfate polyacrylamide gel electrophoresis

TCID 50

tissue culture infectious dose l%

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