Scientific Posters

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).

Digitalization and Automation of the Environmental Monitoring Process in C&GT Manufacturing GMP Facilities: Solution to Leverage QC Operational Efficiency, Compliance and Optimize Resources Allocation

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.

Optimizing Automated Growth-Based Methods for Faster Sterility Release Testing of Cell & Gene Therapy Products

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.

Automated Nucleic Acid Amplification Assay for Mycoplasma Detection in Cell and Gene Therapy Products

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.

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

Bacillus cereus group is composed of B. anthracis, B. cereus, B. cytotoxicus, B. mycoides, B. pseudomycoides, B. thuringiensis and B. weihenstephanensis. Bacillus subtilis group is composed of B. amyloliquefaciens, B. subtilis, B. vallismortis, B. velezensis. They are well known pathogens among the Bacillus genus and can be a source of human infection as well as contaminants in agriculture and food industry. These species are very similar and their differentiation is cumbersome but essential notably in term of epidemiology. 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 study BACT/ALERT® 3D growth promotion antimicrobial neutralization

BACT/ALERT® 3D is an effective, safe and proven solution for industrial sterility testing.

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).

Recombinant Factor C Characterization Studies Confirm the Published Structure and Function of Manufactured rFC

With the advent of first the EU Pharmacopeial Chapter 2.6.32 (2020) and now the publication of USP Chapter <86> (2024) on the use of recombinant Factor C assays, the manufactured products supplied must meet customer confidence expectations in terms of r-Protein characterization. Both current and historical QC characterization tests are described here for ENDOZYME II. The known and therefore expected structure of the complex molecule is shown below from: Shibata et al. 2018 “Intermolecular autocatalytic activation of serine protease zymogen factor C through an active transition state responding to lipopolysaccharide” (1).

Performance validation 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.

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

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.

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).

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.

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.

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.

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. The Most Probable Number (MPN) was used to demonstrate that the LoD of the SCANRDI® CELL-BURST is not significantly different from the LoD of a traditional plate counting method on 10 compendial strains.

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.

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).

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.

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.

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.

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).

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).

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.

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).

Evaluation of a Semi-Automated Endotoxin Testing Workflow

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.

Comparative Study of Preparation Time

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.

3P® SMART Culture Media

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.

Performance Evaluation of a Rapid Fully Automated Mycoplasma Detection System

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.

Validation of a Rapid, Fully Automated Mycoplasma Detection System

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.

A Time-Saving 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).

CT3P LOCKSURE Design Performances

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.

From Parametric Rules to Artificial Intelligence: A New Era in Microbial Image Analysis

Machine learning, particularly deep learning, offers a powerful alternative by learning complex patterns from large datasets, enabling more accurate and adaptable classification.

From Bench to Reality: the Role of Natural Contaminations in LER Investigations

There is ongoing debate regarding the most appropriate type of endotoxin to use in Low Endotoxin Recovery (LER) Hold Time Studies. PDA Technical Report 82 (TR82) recommends Reference Standard Endotoxin (RSE) and Control Standard Endotoxin (CSE) as the primary choices.

Comparing Safety Margin Methods for USP <72> Compliance

Automated growth-based methods are often used for rapid microbial contamination detection in short shelf-life pharmaceutical products such as Cell and Gene Therapies (CGT). For such products, every hour gained on release testing is vital to patients in need.