Human Platelet Lysate for Good Manufacturing Practice-Compliant Cell Production

International Journal of Molecular Sciences, 2021 · DOI: https://doi.org/10.3390/ijms22105178 · Published: May 13, 2021

Simple Explanation

Human platelet lysate (HPL) serves as an effective alternative to fetal bovine serum in cell cultures, promoting cell proliferation for cell-based therapies. HPL is created from platelet concentrates, which are obtained from healthy blood donors and processed according to strict regulatory standards. Quality controls and defined release criteria are crucial for ensuring safe and GMP-compliant HPL production, addressing key aspects like identity, purity, potency, and safety.

Study Duration

Not specified

Participants

Healthy blood donors

Evidence Level

Review

Key Findings

1
HPL promotes efficient cell proliferation, making it suitable for manufacturing cell therapeutics within reasonable timeframes.
2
Pooling individual platelet lysate units can balance donor variation in growth factors and cytokines, enhancing consistency.
3
Pathogen reduction technologies enhance HPL safety, although their impact on platelet biology requires further assessment.

Research Summary

Human platelet lysate (HPL) is a valuable alternative to fetal bovine serum (FBS) as a cell culture medium supplement for various cell types, enabling animal serum-free cell propagation. Dedicated quality issues regarding identity, purity, potency, traceability, and safety must be considered by HPL providers, with defined release criteria characterizing the suitability of HPL batches for specific cell cultures. Aspects and regulatory requirements of whole blood donation, details of HPL manufacturing, international guidelines for raw materials, quality controls, and release criteria for safe and GMP-compliant HPL production are discussed.

Practical Implications

GMP-Compliant Cell Manufacturing

HPL is becoming a new standard, particularly for cell types where serum-free media are not yet available.

Cost-Effective Cell Expansion

HPL offers a cost-effective alternative to FBS due to the utilization of expired platelet concentrates.

Enhanced Cell Proliferation

Increased cell proliferation in HPL culture enables the sufficient production of safe cell therapeutics within a suitable timeframe.

Study Limitations

1
Potential risk for transfusion-transmitted diseases may increase with the number of donors in pooled HPL.
2
The precise mechanism of action of platelet-derived substances in HPL still needs to be defined.
3
Efﬁcacy and potency of HPL produced from PR-treated platelet concentrates may be affected

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