Pharmaceutical Quality Control Scientific Posters

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.

Making quantitative in-house microbiological culture stocks for USP<61> Growth Promotion Testing (GPT) can be time consuming and needs knowledgeable and experienced analysts. The time required for stock culture preparation and plating can be considerable and if the results are out of specification, the GPT needs to be repeated and may require investigation.

Traditional culture media is integral for any environmental monitoring program. Whether it is used for microbial contamination monitoring or making product release decisions, choosing the right prepared culture media to deliver accurate results is essential.

The BIOFIRE® Mycoplasma Panel is a closed and fully automated “lab in a pouch” system that provides highly sensitive and broad detection of Mollicutes with less than five minutes of hands-on time. The disposable reagent pouch integrates nucleic acid purification and nested multiplex real-time PCR with less than one hour of run time and requires minimal training and skill to operate.

The BIOFIRE® Mycoplasma Detection System can facilitate screening at various stages of the manufacturing process for low-level mycoplasma contamination in a wide range of possible sample types.

In order to master and minimize the impact on microbial growth, bioMérieux has worked with a team of experts in fluid dynamics at the Centre Scientifique et Technique du Bâtiment (CSTB) from Nantes in France, who master cutting edge technologies on experimental simulations in climatic wind tunnel and numerical simulations (CFD) of aerodynamics.

Automated Growth-based methods are used for rapid detection of microbial contamination in pharmaceutical products such as Cell and gene therapy (CGT). For therapies on the critical path to patient treatment, every day/hour gained on release testing is crucial to accelerate delivery to patients in need.

Microbial 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. Besides, there is growing interest in EM automation technologies.

Cell and gene therapies (C&GT) or Advanced Therapeutic Medicinal Products (ATMP) are innovative medicine developed to treat cancers, rare diseases, autoimmune disorders, and injuries. As these therapies utilize living cells, they produce a product with a short shelf life. While microbiological examination of cell-based products is critical to ensure patient safety, challenges exist to enable testing and obtaining rapid results prior to patient infusion.

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.

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

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.

CAGT manufacturers have widely adopted automated growth-based technologies as an alternative to the compendial USP <71> sterility test.

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.

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).

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."

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.

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.

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).

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.

This study presents the performances of the 3P culture media allowing them to be the most comprehensive solution for environmental monitoring in classified area.

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.

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).

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.