Abstract
Background & Aim Quality controls used for ATMPs remain at an early stage of development and, given the intrinsic nature of the specific cell-based preparations, are subject to human factor issues without technical standardization. During the evaluation of marketing authorization applications (MAAs), “major objections” relative to suitable quality and clinical data demonstrating the safety, identity purity, potency and efficacy of ATMPs are the main root cause for licensing product rejection. Adopting the experience from the clinical diagnostic field, the Cell Manufacturing Unit of the Regional University Hospital of Malaga-IBIMA (Spain) has developed the first EXTERNAL QUALITY ASSURANCE (EQA) PROGRAMME specifically designed for ATMPs with the aim of harmonizing and guiding the manufacturers to develop safe and effective medicines. Methods, Results & Conclusion To join the EQA Programme, each participant should only provide information about the method used for each quality control and will be able to choose quality controls they would like to perform among the following initially considered: cell count and viability (Ph. Eur. 2.7.29), microbiological control of cell-based preparations (Ph. Eur. 2.6.27), endotoxins (Ph. Eur. 2.6.14), mycoplasma detection (Ph. Eur. 2.6.7), immunophenotyping (Ph. Eur. 2.7.24), gram/calcofluor staining, thawing yield, in-house growth promotion test and karyotype. Additional test will be further considered. Once each 6 months, participants shall receive samples specifically designed for each test. By using in house routine analytical methods, each participant will analyze and upload the results to the program website. After the deadline for results submission, participants shall be able to download a final report where their particular results will be statistically compared by using a specifically designed software. The Programme guarantees the absolute anonymity of both, participants and results. Pilot study and Programme website will be launched during the first half of 2020 with at least 6 academic institutions in Spain and France. Additional interested manufacturers are welcome. In conclusion, the first EQA Program could solve remaining questions about the successful implementation of tools used to measure the quality and efficacy of manufactured ATMPs. In addition, it will also allow to know the degree of expertise and training of involved staff enabling each participant to identify sources of inaccuracy, implement corrective measures and avoid unnecessary efforts.
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