From Extraction to Cryobanking: Which Critical Process Parameters Genuinely Improve DPSC Production?

Area of Science:

• Regenerative Medicine
• Stem Cell Biology
• Bioprocessing

Background:

• Advanced therapy medicinal products (ATMPs) require stringent control of critical process parameters (CPPs) for efficient manufacturing.
• The influence of donor systemic factors like vitamin D status versus technical parameters on dental pulp-derived stem cell (DPSC) production is not well understood.

Purpose of the Study:

• To investigate the impact of donor vitamin D status and critical process parameters on DPSC yield and quality.
• To identify key factors for optimizing DPSC manufacturing for ATMPs.

Main Methods:

• Prospective observational study of 250 adults undergoing third molar extraction.
• Standardized Standard Operating Procedure (SOP) for DPSC processing with varied preparation methods and enzyme conditions.
• Analysis of serum 25(OH)D concentration, cell yield, passage number, and post-thaw viability.

Main Results:

• Donor vitamin D status was not significantly associated with DPSC yield or passage number.
• Scissor preparation yielded significantly more cells than mechanical methods (median 5.00 vs. 1.00 million).
• Type II collagenase and passage number were significant positive predictors of cell yield, with passage number being the strongest predictor.

Conclusions:

• DPSC manufacturing efficiency is primarily driven by critical process parameters, including preparation method, enzyme selection, and passage control.
• Donor vitamin D status did not significantly impact DPSC production outcomes under the studied SOP.
• Process standardization is crucial for reproducible ATMP manufacturing.