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  • 1
    Electronic Resource
    Electronic Resource
    Overview of a quality assurance/quality control compliance program consistent with FDA regulations and policies for somatic cell and gene therapies: a four year experience (1994)
    Springer
    Cytotechnology 15 (1994), S. 365-372 
    Details
    ISSN: 1573-0778
    Keywords: Autolymphocyte therapy ; somatic cellular therapy ; gene therapy ; compliance ; FDA ; quality assurance ; regulations
    Source: Springer Online Journal Archives 1860-2000
    Topics: Biology , Medicine , Process Engineering, Biotechnology, Nutrition Technology
    Notes: Abstract Somatic cell and gene therapy involve the application of biological technologies to an individual patient through the use of living cells which provide a therapeutic benefit (Aliski, 1991). Various forms of cellular and gene therapies are being developed and evaluated in an increasing number of clinical trials for congential and acquired disorders. The potential and progress of these therapeutic applications have resulted in an increasing effort by the Food and Drug Administration (FDA) to develop the regulatory framework under which these therapeutic approaches would insure safety and efficacy, the primary mandate of the FDA. Over five years ago Cellcor began to define the parameters, specifications, and conditions relevant to a Quality Assurance/Quality Control (QA/QC) program that has evolved to insure safety and maximize the efficacy of applications of the company'sex vivo technology, autolymphocyte therapy. Autolymphocyte therapy is an outpatient form of somatic cell immunotherapy based upon the infusion of T cells that have been activatedex vivo using a combination of previously generated autologous cytokines and an anti-CD3 monoclonal antibody. We have been able to demonstrate the feasibility for the safe, controlled, and consistent preparation and delivery of a cellular therapy by application of relevant GMP regulations. This presentation reviews aspects of this program and chronicles our experience which at present amounts to over 4400 infusions for over 700 patients. This program provides a high degree of assurance that a cellular therapy program can be carried out in a multisite mode involving hundreds of patients through the strict adherence to cGMP as set forth in existing regulations. It would be prudent that developers of cellular andex vivo gene therapies establish a similar cell processing and QA/QC infrastructure at an early developmental stage to optimize safety and reproducibility and facilitate regulatory review.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1007/BF00762411
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    Paper (German National Licenses)
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  • 2
    Electronic Resource
    Electronic Resource
    A 3-year experience of quality control and quality assurance in the multisite delivery of a lymphocyte-based cellular therapy for renal cell carcinoma (1994)
    New York, NY [u.a.] : Wiley-Blackwell
    Biotechnology and Bioengineering 43 (1994), S. 693-699 
    Details
    ISSN: 0006-3592
    Keywords: renal cell carcinoma ; lymphocyte therapy ; immunotherapy ; T cells ; Chemistry ; Biochemistry and Biotechnology
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Biology , Process Engineering, Biotechnology, Nutrition Technology
    Notes: Autolymphocyte therapy (ALT) is outpatient-based adoptive immunotherapy using ex vivo-activated memory T-cells. To support the safe and reproducible delivery of ALT at three cell processing facilities (Boston, MA; Atlanta, GA; Orange, CA) we created a comprehensive quality assurance/quality control program compliant with recent FDA guidance relevant to activated lymphocytes and somatic cell therapies. Each facility performed extensive QC testing to ensure sterility, viability, and proper cell yield. Additonally, several QC tests were performed at Cellocr′s centralized reference laboratory to monitor cell potency and identity of the ex vivo-processed lymphocytes. We report here the successful implementation of this QA/QC program for ALT which has resulted in the safe preparation and delivery of cell infusion products amounting to over 3600 treatments at seven clinical sites nationwide. We believe this program will serve as a model for other cellular therapies.
    Additional Material: 7 Ill.
    Type of Medium: Electronic Resource
    URL: http://dx.doi.org/10.1002/bit.260430804
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    Paper (German National Licenses)
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  • 3
    Electronic Resource
    Electronic Resource
    Validation of an automated method of endotoxin testing for use in the end-product testing of ex vivo activated T-lymphocytes used in a somatic cell therapy (1996)
    New York, NY [u.a.] : Wiley-Blackwell
    Biotechnology and Bioengineering 50 (1996), S. 541-547 
    Details
    ISSN: 0006-3592
    Keywords: endotoxin testing ; cellular therapy ; quality control ; Chemistry ; Biochemistry and Biotechnology
    Source: Wiley InterScience Backfile Collection 1832-2000
    Topics: Biology , Process Engineering, Biotechnology, Nutrition Technology
    Notes: The aim of this study was to compare two methods of endotoxin testing to optimize quality control testing methodologies required for the rapid and precise determination of pyrogenicity in cell or tissue products used in cellular therapies. An automated kinetic-chromogenic method for determination of endotoxin levels in ex vivo activated T-lymphocytes infusion product, has been validated following the FDA guideline for the Limulus amebocyte lysate (LAL) assay. The validation protocol included: (1) initial qualification of the laboratory conducting the assay; (2) inhibition and enhancement tests both for treated (heated at 70°C for 10 min) and untreated specimens; and (3) comparison of this assay with the conventional gel-clot method. Inhibition and enhancement testing showed that a 1:30 dilution of the infusion product was the optimal dilution for this type of specimen. Heating specimens did not appear to provide any advantage. A comparison study was performed on 105 infusion product samples. Endotoxin levels determined by both methods for all samples tested were within established end-product release specifications. The K-QCL method can be effectively used for endotoxin determination of ex vivo activated T-cells. © 1996 John Wiley & Sons, Inc.
    Additional Material: 5 Ill.
    Type of Medium: Electronic Resource
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    Paper (German National Licenses)
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