Translational study demonstrates efficient low-density chondrocyte expansion using human platelet lysate, suggesting a viable manufacturing pathway for cartilage repair therapies.
Key Points
To establish a GMP-compatible, risk-based manufacturing framework for expanding human cartilage cells enriched in progenitor markers using human platelet lysate for tissue repair.
Expanded human chondrocytes under low-density culture conditions supplemented with two distinct human platelet lysate (hPL) formulations.
Characterized hPL batches by mass spectrometry proteomics, evaluated cell phenotype via flow cytometry, and assessed chondrogenesis in three-dimensional spheroid cultures.
Applied Failure Modes and Effects Analysis (FMEA) to pinpoint critical process parameters and design targeted risk-mitigation strategies.
Both hPL formulations sustained chondrocyte proliferation, preserved a low immunogenic profile, and maintained high expression of progenitor markers CD146 and CD166 under low-density conditions.
Three-dimensional spheroid cultures retained chondrogenic capacity and produced type II collagen, achieving optimal extracellular matrix deposition at an initial seeding density of 200,000 cells per well.
FMEA risk assessment delineated critical process parameters linked to critical quality attributes, identifying targeted mitigation controls for clinical translation.