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Review of 'Measures to minimize cross-contamination risks in Advanced Therapy Medicinal Product manufacturing'

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Measures to minimize cross-contamination risks in Advanced Therapy Medicinal Product manufacturing

 Livia Roseti (corresponding) ,  Marta Serra,  Brunella Grigolo (2014)
Current European regulations define in vitro expanded cells for clinical purposes as substantially manipulated and include them in the class of Advanced Therapy Medicinal Products to be manufactured in compliance with current Good Manufacturing Practice. These quality requirements are generally thought to be elaborate and costly. However they ensure three main product characteristics: safety, consistency and absence of cross-contamination. The term cross-contamination is used to indicate misidentification of one cell line or culture by another. The Good Manufacturing Practice Guidelines suggest some recommendations in order to prevent cross-contaminations and require a demonstration that the implemented actions are effective. Here we report some practical examples useful both to minimize cross-contamination risks in an Advanced Therapy Medicinal Product production process and to evaluate the efficacy of the adopted measures.
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    Review information

    10.14293/S2199-1006.1.SOR-LIFE.AEJRV9.v1.RRAUFJ

    This work has been published open access under Creative Commons Attribution License CC BY 4.0, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Conditions, terms of use and publishing policy can be found at www.scienceopen.com.

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    Review text

    The paper describes one aspect of the several safety issues encountered by the manufacturer during cell-based medicinal products production. The authors discuss concepts on how to minimize and prevent possible cross contamination, that is considered, together with contamination, as the objectives of GMP, occurring within a manufacturing facility. In the introduction, the authors consider that the quality requirements as required under GMP principles will ensure some of the “main” ATMP characteristics such as safety, consistency and absence of cross-contamination. This is not exactly correct since, as clarified above, cross-contamination is considered as one aspect of safety and that the main ATMP characteristics together with their safety are quality, consistency and traceability.



    The authors use the term cross-contamination in the introduction “to indicate misidentification of one cell line or culture by another”. While all over the text the concept of contamination is rather described, cross contamination is mainly mentioned in the section dealing with analytical tools that can be used to ensure absence of cross-contamination. These legal terms should be clarified and a clear distinction should be made between them; i.e. Cross-contamination is considered as the contamination of a starting material, intermediate or finished product with another starting material or product while contamination refer to the undesired introduction of impurities (of a chemical or microbiological nature) into a starting material, intermediate or AS/FP during the manufacturing process, sampling, packaging or transport.



    The section on “Technical, Organizational, And Behavioral Measures” that is already covered by Part I of the GMP guidelines, although it is summarized, is adequate and provide information to manufacturers about processes to be put in place, to avoid or minimize contamination/cross-contamination scenarios. With regard to the main part of the paper (How to prove the absence of cross-contamination in an ATMP), the authors has given some detailed information on the DNA profiling analytical tool to monitor and provide documented evidence that cross-contamination has not occurred. Although this technique can be suitable test for quality control and traceability, it has also some limitations and offer only statistical probability rather than absolute certainty.

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