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Pharma Quality Control Scientific Posters

Mycoplasma release test with low volume protocol: From sample to results in less than 1 hour

SCIENTIFIC POSTER

Improved Time-To-Detection of Slow Growers Microorganisms with an Automated Growth Based Method

Presenting data to showcase how optimization of BACT/ALERT® 3D DUAL-T incubation conditions can lead to notable improvements in time-to-detection.
Mycoplasma release test with low volume protocol: From sample to results in less than 1 hour

SCIENTIFIC POSTER

Rapid Robust Mycoplasma Detection System for Release Testing of Cell and Gene Therapy Products Containing Mammalian Cells in 1-Hour

Introduce C&GT product specific protocols that allows the inclusion of mammalian cells thus aligning with the upcoming EP guideline (4) whilst providing the required level of detection (≤ 10 CFU/mL) as a Mycoplasma release test.
PERFORMANCE VALIDATION OF ENVIRONMENTAL MONITORING AUTOMATION

SCIENTIFIC POSTER

Differentiation within the Bacillus Cereus and Bacillus Subtilisgroups with Maldi-Tof

Today, no mass spectrometry system is able to differentiate them in routine. The biochemical or molecular techniques are quite fastidious, long and expensive and not always conclusive. 

The objective of this study was to develop a simple and user-friendly method to separate these species by MALDI-TOF.

PERFORMANCE VALIDATION OF ENVIRONMENTAL MONITORING AUTOMATION

SCIENTIFIC POSTER

Mycoplasma release test with low volume protocol: From sample to results in less than 1 hour

Presenting a new Low Volume protocol that allows the inclusion of mammalian cells from high cell density products thus aligning with the upcoming EP guideline whilst providing the required level of detection (≤ 10 CFU/mL) as a mycoplasma release test.
PERFORMANCE VALIDATION OF ENVIRONMENTAL MONITORING AUTOMATION

SCIENTIFIC POSTER

Ultra Rapid Microbial Detection in Cell and Gene Therapy Products

The SCANRDI® is an ultra-rapid alternative technology for detecting microbial contaminants in drug products. Designed to meet compendial testing standards, studies on Limit of Detection (LoD) and Equivalency have been performed with a focus on species listed by the Pharmacopeias microorganisms. 

PERFORMANCE VALIDATION OF ENVIRONMENTAL MONITORING AUTOMATION

SCIENTIFIC POSTER

Mycoplasma Release Testing Cell and Gene Therapy Product Samples

Testing for mycoplasma contamination is a required release test for Cell & Gene Therapy (CGT) products as specified in the major pharmacopeias(1-3).

PERFORMANCE VALIDATION OF ENVIRONMENTAL MONITORING AUTOMATION

SCIENTIFIC POSTER

Performance Validation of Environmental Monitoring Automation

Environmental Monitoring (EM) is crucial to assure patient safety. The visual end point reading of petri dishes has been used for decades without a true performance assessment. Automatization technologies are more present and improve EM practices

BACT/ALERT® Microbial Detection

SCIENTIFIC POSTER

A Comparative Performance Study of Adjusted BACT/ALERT® iFA Plus for Growth Promotion

Automated culture systems are widely used for rapid-real-time microbial contamination detection for pharmaceutical products including small molecule, bioproduction, and cell and gene therapy

Scientific poster testing bioproduction samples

SCIENTIFIC POSTER

Testing Bioproduction Samples

This poster presents results from independent studies performed by 4 bioproduction companies using the BIOFIRE® Mycoplasma system that can detect >130 species of mycoplasma. The BIOFIRE® filmarray system condenses all the steps of a conventional PCR test into an enclosed pouch and provides sample to answer in less than one hour with as little as 2 minutes of hands-on time.
Scientific poster Testing Cell Therapy and Bioproduction Samples

SCIENTIFIC POSTER

Testing Cell Therapy and Bioproduction Samples

Various pharmacopoeias, including the USP, specify a test for mycoplasma contamination must be performed as part of the release testing of a product manufactured in the presence of eukaryotic cells (1).