International Forum on <scp>GMP</scp>‐grade human platelet lysate for cell propagation: summary

Strunk, Dirk; Lozano, Miguel; Marks, Denese C.; Loh, Yen Siew; Gstraunthaler, Gerhard; Schennach, Harald; Rohde, Eva; Laner-Plamberger, Sandra; Öller, Michaela; Nystedt, Johanna; Lotfi, Ramin; Rojewski, Markus; Schrezenmeier, Hubert; Bieback, Karen; Schäfer, Richard; Bakchoul, Tamam; Waidmann, Marc; Jonsdottir-Buch, Sandra Mjoll; Montazeri, H.; Sigurjónsson, Ólafur E.; Iudicone, Paola; Fioravanti, Daniela; Pierelli, Luca; Introna, Martino; Capelli, Chiara; Falanga, Anna; Takanashi, Minoko; López-Villar, Olga; Burnouf, Thierry; Reems, Jo Anna; Pierce, Jan; Preslar, Amber; Schallmoser, Katharina

doi:10.1111/vox.12593

Cited by 43 publications

(46 citation statements)

References 8 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…hPL is generally produced out of a varying number of pooled human platelet concentrates [13,18,[42][43][44][45] after platelet lysis by freezing-thawing cycles [20,[43][44][45] or activation by thrombin [13,42] to liberate the substances required for cell culture that are stored in platelet granules [14,15]. However, there is no good manufacturing practice statement concerning the platelet lysis method in hPL production [13].…”

Section: Discussionmentioning

confidence: 99%

Human Platelet Lysate Can Replace Fetal Calf Serum as a Protein Source to Promote Expansion and Osteogenic Differentiation of Human Bone-Marrow-Derived Mesenchymal Stromal Cells

Karadjian

Senger

Essers

et al. 2020

Cells

View full text Add to dashboard Cite

Fetal calf serum (FCS) is frequently used as a growth factor and protein source in bone-marrow-derived mesenchymal stromal cell (BMSC) culture media, although it is a xenogenic product presenting multiple disadvantages including but not limited to ethical concerns. A promising alternative for FCS is human platelet lysate (hPL), which is produced out of human platelet concentrates and happens to be a stable and reliable protein source. In this study, we investigated the influence of hPL in an expansion medium (ESM) and an osteogenic differentiation medium (ODM) on the proliferation and osteogenic differentiation capacity of human BMSC. Therefore, we assessed population doublings during cell expansion, performed alizarin red staining to evaluate the calcium content in the extracellular matrix and determined the activity of alkaline phosphatase (ALP) as osteogenic differentiation correlates. The proliferation rate of BMSC cultured in ESM supplemented with hPL exceeded the proliferation rate of BMSC cultured in the presence of FCS. Furthermore, the calcium content and ALP activity was significantly higher in samples incubated in hPL-supplemented ODM, especially in the early phases of differentiation. Our results show that hPL can replace FCS as a protein supplier in cell culture media and does not negatively affect the osteogenic differentiation capacity of BMSC.

show abstract

Section: Discussionmentioning

confidence: 99%

Human Platelet Lysate Can Replace Fetal Calf Serum as a Protein Source to Promote Expansion and Osteogenic Differentiation of Human Bone-Marrow-Derived Mesenchymal Stromal Cells

Karadjian

Senger

Essers

et al. 2020

Cells

View full text Add to dashboard Cite

show abstract

“…The workshop also recommended the testing of isoagglutinin titers, as these might have a detrimental effect on endothelial cells. Performance testing was recently debated in an international survey organized by the presenter and has recommended testing of platelet‐derived growth factor concentrations or population doubling time of standard MSCs . The European Pharmacopeia monograph 5.2.12 entitled “Raw Materials of Biological Origin for the Production of Cell‐Based and Gene Therapy Medicinal Products” requires explicitly for serum or serum replacement as raw material to show cell growth–promoting properties within defined limits.…”

Section: Hpl: Viral Safety Preclinical Studies and Release Testingmentioning

confidence: 99%

Human platelet lysate current standards and future developments

et al. 2019

View full text Add to dashboard Cite

A state‐of‐the‐art workshop focused on the use of human platelet lysate (HPL) for cell therapy. The meeting established that HPL is used mainly as an adjunct material for ex vivo expansion of mesenchymal stem/progenitor cells (MSCs), where it is successfully used as a substitute for fetal bovine serum. HPL manufacturing as a cell expansion supplement is currently not yet uniformly standardized with regard to platelet source and production methodology. There are very few reports of HPL preparations manufactured specifically for direct clinical use. There exists an urgent need for controlled clinical studies for HPL and for standardization of product definition. Workshop participants also stated a need for consensus minimum release criteria to allow for better product definition and to limit variability in performance. The increasing use of cell‐based therapies including MSCs has led to an increasing demand for HPL, either produced in blood establishments or large‐scale manufacture by biopharmaceutical companies. The use of pooled donor platelets for HPL production may require the implementation of pathogen inactivation procedures and/or removal steps to improve the safety of advanced cell therapy products. There should also be a requirement for thorough risk assessments and risk mitigation steps, including the qualification of suppliers and identification of ingredients as well as meticulous monitoring of product quality and safety profiles. State‐of‐the‐art regulatory approaches for HPL used for human cell propagation and PRP in direct clinical applications were reviewed.

show abstract

“…The "International Forum on GMP-grade human platelet lysate for cell propagation" provides good insight into the huge variability in production and quality testing. 3,4 The European Pharmacopeia general chapter on "Raw materials of biological origin for the production of cell-based and gene therapy medicinal products for human use" [Chapter 5.2.12]) sheds some light in this direction. It states that only carefully evaluated donors adequately tested for infectious transmissible agents according to EU and/or national regulation should be used.…”

Section: Qc and Standards For Releasementioning

confidence: 99%

“…hPL is routinely produced from PLT-rich plasma (PRP) or expired PLTs collected via apheresis. 3,4 Multiple freeze/thaw cycles cause the PLT membranes to burst and release trophogens and growth factors resulting in a lysate. Aggregates, debris, and PLT fragments are removed by centrifugation.…”

mentioning

confidence: 99%

“…Aggregates, debris, and PLT fragments are removed by centrifugation. 3,4 Human PLT lysate can be derived from autologous (same donor) collections, which may minimize the risk of immunologic reactions or infections; however, most efforts have focused on preparing allogeneic pooled batches from blood donations from a large number (50-100) of different individuals. The use of hPL in standard cell culture protocols could prove to be a promising tool for further development of cell therapy products in animal protein-free systems.…”

mentioning

confidence: 99%

See 1 more Smart Citation

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

2019

View full text Add to dashboard Cite

International Forum on GMP‐grade human platelet lysate for cell propagation: summary

Cited by 43 publications

References 8 publications

Human Platelet Lysate Can Replace Fetal Calf Serum as a Protein Source to Promote Expansion and Osteogenic Differentiation of Human Bone-Marrow-Derived Mesenchymal Stromal Cells

Human Platelet Lysate Can Replace Fetal Calf Serum as a Protein Source to Promote Expansion and Osteogenic Differentiation of Human Bone-Marrow-Derived Mesenchymal Stromal Cells

Human platelet lysate current standards and future developments

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

Contact Info

Product

Resources

About