Background: JACIE Standards (FACT Standards in the USA) have been implemented in Europe since 1999. An on-site accreditation inspection took place at our center in January 2004. The purpose of this work was to develop a real-time process/quality control system meeting the JACIE Standards for HPC release.

Methods: Data from 194 HPC processing procedures for autologous transplantation performed over a 5-year period were analyzed. The results of different processing methods applied at our facility were compared: (1) cryopreservation without washing cells (n=50), (2) washing cells (n=87), (3) cell-density separation (n=12) and (4) positive CD34 selection (n=45).

Results: Four critical control points were set for the validation of HPC processing: (a) number of lost CD34(+) cells during processing, (b) contamination, (c) viability of the cells after thawing and (d) ability to reconstitute hematopoiesis after transplantation. On the basis of statistical analysis, ranges of acceptable values were defined for each critical control point and for each processing method. Those acceptable values were used for cell release and real-time quality control.

Discussion: This study describes a model for the validation of HPC processing and for a real-time process/quality control system for HPC release. Optimization of processing techniques, standardization of methods and comparison between facilities will open the way towards external quality controls and quality improvement.

Download full-text PDF

Source
http://dx.doi.org/10.1080/14653240410005032DOI Listing

Publication Analysis

Top Keywords

hpc processing
16
real-time process/quality
12
process/quality control
12
processing
8
jacie standards
8
control system
8
washing cells
8
critical control
8
validation hpc
8
acceptable values
8

Similar Publications

The hippocampus (HPC) has emerged as a critical player in the control of food intake, beyond its well-known role in memory. While previous studies have primarily associated the HPC with food intake inhibition, recent research suggests a role in appetitive processes. Here we identified spatially distinct neuronal populations within the dorsal HPC (dHPC) that respond to either fats or sugars, potent natural reinforcers that contribute to obesity development.

View Article and Find Full Text PDF

Efficient continuous SF/N separation using low-cost and robust metal-organic frameworks composites.

Nat Commun

January 2025

Key Laboratory of Biomass Chemical Engineering of Ministry of Education, College of Chemical and Biological Engineering, Zhejiang University, Hangzhou, Zhejiang, China.

Physisorption presents a promising alternative to cryogenic distillation for capturing the most potent greenhouse gas, SF, but existing adsorbents face challenges in meeting diverse chemical and engineering concerns. Herein, with insights into in-pore chemistry and industrial process design, we report a systematic investigation that constructed two low-cost composites pellets (Al(fum)@2%HPC and Al(fum)@5%Kaolin) coupled with an innovative two-stage Vacuum Temperature Swing Adsorption (VTSA) process for the ultra-efficient recovery of low-concentration SF from N. Record-high selectivities (> 2×10) and SF dynamic capacities (~ 2.

View Article and Find Full Text PDF

Drug-Phospholipid Co-Amorphous Formulations: The Role of Preparation Methods and Phospholipid Selection.

Pharmaceutics

December 2024

Department of Pharmacy, Faculty of Health and Medical Science, University of Copenhagen, Universitetsparken 2, DK-2100 Copenhagen, Denmark.

: This study aims to broaden the knowledge on co-amorphous phospholipid systems (CAPSs) by exploring the formation of CAPSs with a broader range of poorly water-soluble drugs, celecoxib (CCX), furosemide (FUR), nilotinib (NIL), and ritonavir (RIT), combined with amphiphilic phospholipids (PLs), including soybean phosphatidylcholine (SPC), hydrogenated phosphatidylcholine (HPC), and mono-acyl phosphatidylcholine (MAPC). : The CAPSs were initially prepared at equimolar drug-to-phospholipid (PL) ratios by mechano-chemical activation-based, melt-based, and solvent-based preparation methods, i.e.

View Article and Find Full Text PDF

: Transcriptome assembly and functional annotation are essential in understanding gene expression and biological function. Nevertheless, many existing pipelines lack the flexibility to integrate both short- and long-read sequencing data or fail to provide a complete, customizable workflow for transcriptome analysis, particularly for non-model organisms. : We present TrAnnoScope, a transcriptome analysis pipeline designed to process Illumina short-read and PacBio long-read data.

View Article and Find Full Text PDF

Vitrification is a conventional and mature method for embryo cryo-preservation, but ice crystals formed during the vitrification process can damage embryos. HPC has the property of forming a high-viscosity gel under low-temperature conditions, so it can be added to vitrification solutions to investigate whether it improves the negative impact of vitrification on embryos. The results showed that the addition of HPC (50 μg/ml) to the vitrification solution significantly increased the post-warming survival rate of sheep morula embryos.

View Article and Find Full Text PDF

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!