Pharma Quality Control Scientific Posters

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.

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.

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.

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).

Presenting data to showcase how optimization of BACT/ALERT® 3D DUAL-T incubation conditions can lead to notable improvements in time-to-detection.

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.

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.

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.

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. 

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

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

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).