1H-NMR and MALDI-TOF MS as metabolomic quality control tests to classify platelet derived medium additives for GMP compliant cell expansion procedures.

ABSTRACT:

Introduction

Ex vivo cell expansion under Good Manufacturing Practice (GMP) guidelines can be performed using medium additives containing human growth factors from platelets. These products can differently affect proliferation of adipose mesenchymal stromal stem cells (ASC). Qualification of medium additive performance is required for validation under GMP regulations: assessment of growth factor concentrations is not sufficient to predict the biological activity of the product batch. Proton nuclear magnetic resonance spectrometry (1H-NMR) and matrix-assisted laser desorption/ionization time of flight mass spectroscopy (MALDI-TOF MS) provide wide molecular characterization of samples.

Aims

We aimed to assess if 1H-NMR and MALDI-TOF MS techniques can be used as quality control

SUBMITTER: Agostini F 

PROVIDER: S-EPMC6126812 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature