Pharmaceutical Quality Control Scientific Posters

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.

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 (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.

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.