Human Platelet Lysate for Good Manufacturing Practice-Compliant Cell Production

Numerous cell-based therapeutics are currently being tested in clinical trials. Human platelet lysate (HPL) is a valuable alternative to fetal bovine serum as a cell culture medium supplement for a variety of different cell types. HPL as a raw material permits animal serum-free cell propagation with highly efficient stimulation of cell proliferation, enabling humanized manufacturing of cell therapeutics within a reasonable timeframe. Providers of HPL have to consider dedicated quality issues regarding identity, purity, potency, traceability and safety. Release criteria have to be defined, characterizing the suitability of HPL batches for the support of a specific cell culture. Fresh or expired platelet concentrates from healthy blood donors are the starting material for HPL preparation, according to regulatory requirements. Pooling of individual platelet lysate units into one HPL batch can balance donor variation with regard to essential platelet-derived growth factors and cytokines. The increasingly applied pathogen reduction technologies will further increase HPL safety. In this review article, aspects and regulatory requirements of whole blood donation and details of human platelet lysate manufacturing are presented. International guidelines for raw materials are discussed, and defined quality controls, as well as release criteria for safe and GMP-compliant HPL production, are summarized.

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Gaps in the knowledge of human platelet lysate as a cell culture supplement for cell therapy: a joint publication from the AABB and the International Society for Cell & Gene Therapy

Transfusion ◽

10.1111/trf.15483 ◽

2019 ◽

Vol 59 (11) ◽

pp. 3448-3460 ◽

Cited By ~ 6

Author(s):

Karen Bieback ◽

Beatriz Fernandez‐Muñoz ◽

Shibani Pati ◽

Richard Schäfer

Keyword(s):

Gene Therapy ◽

Cell Culture ◽

Cell Therapy ◽

International Society ◽

Human Platelet ◽

Platelet Lysate ◽

Joint Publication ◽

Human Platelet Lysate ◽

A Cell ◽

Cell Gene

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Human platelet lysate as a fetal bovine serum substitute improves human adipose-derived stromal cell culture for future cardiac repair applications

Cell and Tissue Research ◽

10.1007/s00441-012-1360-5 ◽

2012 ◽

Vol 348 (1) ◽

pp. 119-130 ◽

Cited By ~ 59

Author(s):

B. A. Naaijkens ◽

H. W. M. Niessen ◽

H-J. Prins ◽

P. A. J. Krijnen ◽

T. J. A. Kokhuis ◽

...

Keyword(s):

Cell Culture ◽

Stromal Cell ◽

Human Platelet ◽

Fetal Bovine Serum ◽

Cardiac Repair ◽

Platelet Lysate ◽

Human Platelet Lysate ◽

Stromal Cell Culture ◽

Fetal Bovine ◽

Serum Substitute

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Generation of a Pool of Human Platelet Lysate and Efficient Use in Cell Culture

Basic Cell Culture Protocols - Methods in Molecular Biology ◽

10.1007/978-1-62703-128-8_22 ◽

2012 ◽

pp. 349-362 ◽

Cited By ~ 51

Author(s):

Katharina Schallmoser ◽

Dirk Strunk

Keyword(s):

Cell Culture ◽

Human Platelet ◽

Platelet Lysate ◽

Human Platelet Lysate

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Human Platelet Lysate as a Promising Growth-Stimulating Additive for Culturing of Stem Cells and other Cell Types

Bulletin of Experimental Biology and Medicine ◽

10.1007/s10517-013-2298-7 ◽

2013 ◽

Vol 156 (1) ◽

pp. 146-151 ◽

Cited By ~ 24

Author(s):

Ya. D. Shanskii ◽

N. S. Sergeeva ◽

I. K. Sviridova ◽

M. S. Kirakozov ◽

V. A. Kirsanova ◽

...

Keyword(s):

Stem Cells ◽

Human Platelet ◽

Cell Types ◽

Platelet Lysate ◽

Human Platelet Lysate

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Gelatin-Methacryloyl (GelMA) Formulated with Human Platelet Lysate Supports Mesenchymal Stem Cell Proliferation and Differentiation and Enhances the Hydrogel’s Mechanical Properties

Bioengineering ◽

10.3390/bioengineering6030076 ◽

2019 ◽

Vol 6 (3) ◽

pp. 76 ◽

Cited By ~ 5

Author(s):

Marline Kirsch ◽

Luise Birnstein ◽

Iliyana Pepelanova ◽

Wiebke Handke ◽

Jessica Rach ◽

...

Keyword(s):

Cell Culture ◽

Stem Cell ◽

Mesenchymal Stem Cell ◽

Osteogenic Differentiation ◽

Cell Cultures ◽

Human Platelet ◽

3D Cell Culture ◽

Platelet Lysate ◽

Dependent Manner ◽

Human Platelet Lysate

Three-dimensional (3D) cell culture is a major focus of current research, since cultivation under physiological conditions provides more reliable information about in vivo cell behavior. 3D cell cultures are used in basic research to better understand intercellular and cell-matrix interactions. However, 3D cell culture plays an increasingly important role in the in vitro testing of bioactive substances and tissue engineering. Gelatin-methacryloyl (GelMA) hydrogels of different degrees of functionalization (DoFs) are a versatile tool for 3D cell culture and related applications such as bioprinting. Human platelet lysate (hPL) has already demonstrated positive effects on 2D cell cultures of different cell types and has proven a valuable alternative to fetal calf serum (FCS). Traditionally, all hydrogels are formulated using buffers. In this study, we supplemented GelMA hydrogels of different DoF with hPL during adipose tissue-derived mesenchymal stem cell (AD-MSCs) encapsulation. We studied the effect of hPL supplementation on the spreading, proliferation, and osteogenic differentiation of AD-MSCs. In addition, the influence of hPL on hydrogel properties was also investigated. We demonstrate that the addition of hPL enhanced AD-MSC spreading, proliferation, and osteogenic differentiation in a concentration-dependent manner. Moreover, the addition of hPL also increased GelMA viscosity and stiffness.

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Heparin concentration is critical for cell culture with human platelet lysate

Cytotherapy ◽

10.1016/j.jcyt.2013.05.006 ◽

2013 ◽

Vol 15 (9) ◽

pp. 1174-1181 ◽

Cited By ~ 38

Author(s):

Hatim Hemeda ◽

Jana Kalz ◽

Gudrun Walenda ◽

Michael Lohmann ◽

Wolfgang Wagner

Keyword(s):

Cell Culture ◽

Human Platelet ◽

Platelet Lysate ◽

Heparin Concentration ◽

Human Platelet Lysate

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Human Platelet Lysate Supports Efficient Expansion and Stability of Wharton’s Jelly Mesenchymal Stromal Cells via Active Uptake and Release of Soluble Regenerative Factors

International Journal of Molecular Sciences ◽

10.3390/ijms21176284 ◽

2020 ◽

Vol 21 (17) ◽

pp. 6284

Author(s):

Mariana Cañas-Arboleda ◽

Karl Beltrán ◽

Carlos Medina ◽

Bernardo Camacho ◽

Gustavo Salguero

Keyword(s):

Regenerative Medicine ◽

Human Platelet ◽

Functional Characterization ◽

Platelet Lysate ◽

Wharton’S Jelly ◽

Raw Material ◽

Great Opportunity ◽

Wharton's Jelly ◽

Human Platelet Lysate ◽

Efficient Expansion

Manufacturing of mesenchymal stromal cell (MSC)-based therapies for regenerative medicine requires the use of suitable supply of growth factors that enhance proliferation, cell stability and potency during cell expansion. Human blood derivatives such as human platelet lysate (hPL) have emerged as a feasible alternative for cell growth supplement. Nevertheless, composition and functional characterization of hPL in the context of cell manufacturing is still under investigation, particularly regarding the content and function of pro-survival and pro-regenerative factors. We performed comparative analyses of hPL, human serum (hS) and fetal bovine serum (FBS) stability and potency to support Wharton’s jelly (WJ) MSC production. We demonstrated that hPL displayed low inter-batch variation and unique secretome profile that was not present in hS and FBS. Importantly, hPL-derived factors including PDGF family, EGF, TGF-alpha, angiogenin and RANTES were actively taken up by WJ-MSC to support efficient expansion. Moreover, hPL but not hS or FBS induced secretion of osteoprotegerin, HGF, IL-6 and GRO-alpha by WJ-MSC during the expansion phase. Thus, hPL is a suitable source of factors supporting viability, stability and potency of WJ-MSC and therefore constitutes an essential raw material that in combination with WJ-MSC introduces a great opportunity for the generation of potent regenerative medicine products.

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