Optimization of human platelet lysate production and pathogen reduction in a public blood transfusion center

González, María Bermejo; Campos‐Cuerva, Rafael; Fernández‐Muñoz, Beatriz; Rosell‐Valle, Cristina; Martín-López, María; Arribas, Blanca Arribas; Montiel, Migue Ángel; Sánchez, Gloria Carmona; Gonzalez, M.S.

doi:10.1111/trf.17045

Cited by 2 publications

(2 citation statements)

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“…Based on a bibliographic study and our laboratory experience, we developed different formulations to evaluate cryopreserving of NFAHs and commonly used cells. hPL and ihPL were produced as described [10].…”

Section: Testing Hpl-based Solutionsmentioning

confidence: 99%

“…Several xeno-free cryopreservation solutions are available in the market; however, to date, none of them base their formulation on pathogen-inactivated hPL (ihPL), which has been successfully tested as a xenofree culture supplement for the expansion of different cell types [3]. Moreover, to comply with the latest recommendations on blood derivatives [9] that advise pathogen-reduction treatments to minimize the risk of viral and bacterial transmission in blood products [5], we have manufactured ihPL preparations to formulate our solutions [10].…”

Section: Introductionmentioning

confidence: 99%

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Bioengineered tissue and cell therapy products are efficiently cryopreserved with pathogen-inactivated human platelet lysate-based solutions

Martín-López¹,

Rosell‐Valle²,

Arribas-Arribas³

et al. 2023

Preprint

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Background There remains much interest in improving cryopreservation techniques for advanced therapy medicinal products (ATMPs). Recently, human platelet lysate (hPL) has emerged as a promising candidate to replace fetal bovine serum (FBS) as a xeno-free culture supplement for the expansion of human cell therapy products. Whether hPL can also substitute for FBS in cryopreservation procedures remains poorly studied. Here, we evaluated several cryoprotective formulations based on a proprietary hPL for the cryopreservation of bioengineered tissues and cell therapy products. Methods We tested different xenogeneic-free, pathogen-inactivated hPL (ihPL)- and non-inactivated-based formulations for cryopreserving bioengineered tissue (cellularized nanostructured fibrin agarose hydrogels (NFAHs)) and common cell therapy products including bone marrow-derived mesenchymal stromal cells (BM-MSCs), human dermal fibroblasts (FBs) and neural stem cells (NSCs). To assess the tissue and cellular properties post-thaw of NFAHs, we analyzed their cell viability, identity and structural and biomechanical properties. Also, we evaluated cell viability, recovery and identity post-thaw in cryopreserved cells. Further properties like immunomodulation, apoptosis and cell proliferation were assessed in certain cell types. Additionally, we examined the stability of the formulated solutions. The formulations are under a bidding process with MD Bioproducts (Zurich, Switzerland) and are proprietary. Results Amongst the tissue specific solutions, Ti5 (low-DMSO and ihPL-based) preserved the viability and the phenotype of embedded cells in NFAHs and preserved the matrix integrity and biomechanical properties similar to those of the standard cryopreservation solution (70% DMEM + 20% FBS + 10% DMSO). All solutions were stable at -20ºC for at least 3 months. Regarding cell specific solutions, CeA, maintained the viability of all cell types > 80%, preserved the immunomodulatory properties of BM-MSCs and promoted good recovery post-thaw. Besides, both tested solutions were stable at -20ºC for 18 months. Finally, we established that there is a 3-hour window in which thawed NFAHs and FBs, maintain optimum viability immersed in the formulated solutions; and, at least 2 h for BM-MSCs. Conclusions Our results show that pathogen-inactivated solutions Ti5 -allocated for bioengineered tissues- and CeA -allocated for cells- are efficient and safe candidates to cryopreserve ATMPs, and offer a xenogeneic-free and low-DMSO alternative to commercially available cryoprotective solutions.

show abstract

Section: Testing Hpl-based Solutionsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Bioengineered tissue and cell therapy products are efficiently cryopreserved with pathogen-inactivated human platelet lysate-based solutions

Martín-López¹,

Rosell‐Valle²,

Arribas-Arribas³

et al. 2023

Preprint

View full text Add to dashboard Cite

show abstract

Bioengineered tissue and cell therapy products are efficiently cryopreserved with pathogen-inactivated human platelet lysate-based solutions

et al. 2023

View full text Add to dashboard Cite

Background There remains much interest in improving cryopreservation techniques for advanced therapy medicinal products (ATMPs). Recently, human platelet lysate (hPL) has emerged as a promising candidate to replace fetal bovine serum (FBS) as a xeno-free culture supplement for the expansion of human cell therapy products. Whether hPL can also substitute for FBS in cryopreservation procedures remains poorly studied. Here, we evaluated several cryoprotective formulations based on a proprietary hPL for the cryopreservation of bioengineered tissues and cell therapy products. Methods We tested different xenogeneic-free, pathogen-inactivated hPL (ihPL)- and non-inactivated-based formulations for cryopreserving bioengineered tissue (cellularized nanostructured fibrin agarose hydrogels (NFAHs)) and common cell therapy products including bone marrow-derived mesenchymal stromal cells (BM-MSCs), human dermal fibroblasts (FBs) and neural stem cells (NSCs). To assess the tissue and cellular properties post-thaw of NFAHs, we analyzed their cell viability, identity and structural and biomechanical properties. Also, we evaluated cell viability, recovery and identity post-thaw in cryopreserved cells. Further properties like immunomodulation, apoptosis and cell proliferation were assessed in certain cell types. Additionally, we examined the stability of the formulated solutions. The formulations are under a bidding process with MD Bioproducts (Zurich, Switzerland) and are proprietary. Results Amongst the tissue-specific solutions, Ti5 (low-DMSO and ihPL-based) preserved the viability and the phenotype of embedded cells in NFAHs and preserved the matrix integrity and biomechanical properties similar to those of the standard cryopreservation solution (70% DMEM + 20% FBS + 10% DMSO). All solutions were stable at − 20 °C for at least 3 months. Regarding cell-specific solutions, CeA maintained the viability of all cell types > 80%, preserved the immunomodulatory properties of BM-MSCs and promoted good recovery post-thaw. Besides, both tested solutions were stable at − 20 °C for 18 months. Finally, we established that there is a 3-h window in which thawed NFAHs and FBs maintain optimum viability immersed in the formulated solutions and at least 2 h for BM-MSCs. Conclusions Our results show that pathogen-inactivated solutions Ti5 allocated for bioengineered tissues and CeA allocated for cells are efficient and safe candidates to cryopreserve ATMPs and offer a xenogeneic-free and low-DMSO alternative to commercially available cryoprotective solutions.

show abstract

Optimization of human platelet lysate production and pathogen reduction in a public blood transfusion center

Cited by 2 publications

References 61 publications

Bioengineered tissue and cell therapy products are efficiently cryopreserved with pathogen-inactivated human platelet lysate-based solutions

Bioengineered tissue and cell therapy products are efficiently cryopreserved with pathogen-inactivated human platelet lysate-based solutions

Bioengineered tissue and cell therapy products are efficiently cryopreserved with pathogen-inactivated human platelet lysate-based solutions

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