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Pharmaceutical Quality Control Scientific Posters

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

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

Endotoxins

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

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

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

Endotoxins

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

Rapids 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

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

Endotoxins - Validation of ENDOZYME II GO

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

Endotoxins

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

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.