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Pharmaceutical Quality Control Scientific Posters

PERFORMANCE VALIDATION OF ENVIRONMENTAL MONITORING AUTOMATION

SCIENTIFIC POSTER

A Comparative Performance Study of Adjusted BACT/ALERT iFA Plus for Growth Promotion and Antimicrobial Neutralization

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 (CAGT)1,2,3. CAGT manufacturers have widely adopted automated growth-based technologies as an alternative to the compendial USP <71> sterility test or by following the compendial EP 2.6.27 that includes automated growth-based methods for detection of contaminating microorganisms4,5.

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

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).
Scientific Poster Mechanisms of Hidden Endotoxin in Biologics Manufacturing

SCIENTIFIC POSTER

Mechanisms of Hidden Endotoxin in Biologics Manufacturing

Bioburden concerns are cited after regulatory scrutiny: • Multiple lots of DS released which had unacceptable high levels of bioburden during the final purification steps. • No microbial limits are established for processing steps, and results show high bioburden levels (>1000 CFU/mL). • "... during the harvest of the unprocessed bulk, sublots of Lot xxxx and Lot yyyy exceeded the established action limits for bioburden."
Scientific Poster VITEK® MS - Accurate Identification of Environmental Bacteria

SCIENTIFIC POSTER

VITEK® MS - Accurate Identification of Environmental Bacteria

Used in contamination investigations and to understand the microbial ecology of a manufacturing facility, accurate microbial identification (ID) is an essential part of pharmaceutical quality control testing. In this study we demonstrate the accuracy of bioMérieux’s latest VITEK® MS knowledge base (KB) which uses Matrix-Assisted Laser Desorption Ionization – Time of Flight Mass Spectrometry (MALDI-TOF) for ID of microorganisms in pharmaceutical environments.
Scientific Poster Endotoxins - Evaluation of a Semi-Automated Endotoxin Testing Workflow

SCIENTIFIC POSTER

Endotoxins - Evaluation of a Semi-Automated Endotoxin Testing Workflow

The ENDOZYME® II GO was recently developed including a 96-well microplate pre-loaded with required Control Standard Endotoxin (CSE) amounts for the standard curve as well as Positive Product Controls (PPC). In order to minimize handling time and further optimize the assay workflow, without the need for dedicated personnel, a semi-automated solution including an automated pipetting robot has now been assessed.
Scientific Poster Endotoxin A New Product Offer for Recombinant Factor C Endotoxin Testing

SCIENTIFIC POSTER

Endotoxin A New Product Offer for Recombinant Factor C Endotoxin Testing

The vast majority of endotoxin tests for pharmaceuticals and medical devices as well as their in-process intermediates and raw materials are microplate-based. They require tedious reconstitution and dilution steps for preparation of Control Standard Endotoxin (CSE) dilutions and Positive Product Controls (PPCs).
Scientific Poster Accelerate the Implementation and Use of Rapid Methods

SCIENTIFIC POSTER

Accelerate the Implementation and Use of Rapid Methods

The validation of the alternative and rapid microbiological methods are regulated by the United States Pharmacopeia chapter <1223>. Validation of alternative Microbiological Methods; the European pharmacopeia chapter 5.1.6 Alternate Methods for control of microbiological quality, and Rapid Microbial Method of the Japanese Pharmacopeia JP17, mainly.
Scientific Poster Performance Study TSA 3P TSA 3P With Neutralisers COUNT-TACT 3P

SCIENTIFIC POSTER

Performance Study TSA 3P, TSA 3P With Neutralisers, COUNT-TACT 3P

This study presents the performances of the 3P culture media allowing them to be the most comprehensive solution for environmental monitoring in classified area.
Scientific Poster Validation of ENDOZYME II GO Time-Saving Endotoxin Assay

SCIENTIFIC POSTER

Endotoxin - Validation of  ENDOZYME II GO Time-Saving Endotoxin Assay

Given the reduction in horseshoe crab numbers as well as a drastic reduction in the numbers of shore-birds on the Atlantic seaboard, many seek to reduce pharmaceutical reliance on the Limulus test re-agent (LAL). Recombinant factor C is a recombinantly produced protein expressed from the cloned horseshoe crab gene in cell culture.
Scientific Poster Time-Saving Recombinant Factor C (rFC) Endotoxin Test

SCIENTIFIC POSTER

A Time-Saving Recombinant Factor C (rFC) Endotoxin Test

The vast majority of endotoxin tests for pharmaceuticals and medical devices as well as their in-process intermediates and raw materials are microplate-based. They require tedious reconstitution and dilution steps for preparation of Control Standard Endotoxin (CSE) dilutions and Positive Product Controls (PPCs).
Scientific Poster Quality Control of BACT/ALERT® Culture Media

SCIENTIFIC POSTER

Quality Control of BACT/ALERT® Culture Media

A study was conducted using commercially prepared organisms evaluating both a comprehensive organism panel as well as a streamlined method utilizing only two organisms from the panel.