Rated 2.5 of 5.
Level of importance:
Rated 3 of 5.
Level of validity:
Rated 2 of 5.
Level of completeness:
Rated 2 of 5.
Level of comprehensibility:
Rated 3 of 5.
|ScienceOpen disciplines:||Life sciences|
|Keywords:||Autologous Chondrocyte Implantation, Good Manufacturing Practice, Cross-contamination, Advanced Therapy Medicinal Products, DNA Profiling|
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.