First Commercially-Available Mycoplasma Detection Test Accepted by FDA
Roche's MycoTOOL, which offers rapid detection of mycoplasms based on a polymerase chain reaction (PCR) test, has received FDA acceptance.
Roche's MycoTOOL, which offers rapid detection of mycoplasms based on a polymerase chain reaction (PCR) test, has received FDA acceptance. This is the first commercially-available Mycoplasma PCR test accepted by the FDA for the release testing of a biopharmaceutical product that can replace traditional and time-consuming Mycoplasma detection assays which use growth on culture media and in vitro assays to detect contaminating organisms.
Mycoplasma contamination is a common and significant issue in biopharmaceutical production, cell therapy, tissue engineering, and vaccine manufacturing. The conventional culture-based detection methods required by pharmacopoeias and drug-regulating agencies are time-consuming as they can take as much as 28 days to complete, making them laborious and difficult to interpret. Ruedi Stoffel, head of custom biotech at Roche, said in a press statement, "Fast methods, like our new MycoTOOL test, will greatly enhance the efficiency, quality and safety in the manufacturing process of pharmaceutical and biological products."
The MycoTOOL PCR Mycoplasma detection kit provides all critical reagents for performing sample preparation and PCR. The tool is compatible with a range of sample types, including cellular matrices (human cells, primary and continuous), canine cells, nonhuman primate cells, various rodent cell types, and cell-free matrices (culture supernatants of CHO or human-stem cells, and egg-derived samples). It also detects the broad panel of Mollicute species. The test minimizes the risk of false negative and false positive test results. The risk of undetected intracellular Mycoplasma is eliminated by lysis controls of the matrix while positive controls verify potential PCR inhibition. Nucleic acid free reagents prevent false positives, and the use of uracil-DNA glycosylase minimizes the risk of PCR carryover contamination.
Harnessing mRNA as a Readout to Develop Robust BioPotency Assays
December 12th 2024Transcriptional activity within a cell can be used to evaluate cell response to a ligand or promoter activity within a transgene or plasmid within a cell. Catalent has developed a relative potency bioassay using real-time quantitative reverse transcription (RT-qPCR) in a duplex format to assess relative transcription activity in cells treated with ligands or transgenic vectors. The assay utilizes two fluorescent dyes with minimally overlapping emission spectra that allow real-time monitoring of the gene expression of both target and normalizer genes. The assay does not require purification of the mRNA produced by the cells once lysis has occurred. Normalizing the qPCR cycle thresholds (CT) of the target transcript to the reference transcript allows response curve to be generated and compared to a reference standard. The generation of a four-parameter fit curve analysis from raw qPCR cycle threshold data allows for comparison of relative potency and assessment of suitability based on curve parallelism. The assay platform has been used by Catalent to qualify a repeatable, accurate, linear, and specific bioassay for assessing relative potency.
The Solution Lies with SOLBIOTE™: Achieving Sustainability, a Growing Focus in Biopharma
October 28th 2024The nexus between biopharmaceuticals and sustainability is seemingly far apart, however, it is increasingly recognized as an inevitable challenge. It is encouraged to take a sustainable approach to reducing the environmental impact of the production and supply of medicines while improving people's health; delivering the well-being of people and the planet. Yosuke Shimojo (Technical Value Support Section Manager, Nagase Viita) will unveil how SOLBIOTE™, a portfolio of injectable-grade saccharide excipients, would be a key for the biopharmaceutical development and achieving sustainability for a better future of the industry.
Exploring New and Improved Analytical Methods for Traditional and Unique Modalities
December 12th 2024Biophysical characterization is critical to understand the make-up and behaviors of biologic therapies and vaccines, both early in development and throughout the manufacturing scale-up process. As biologics become more complex in structure, and as scientists improve their understanding of the effects of structure on stability, efficacy, safety, etc., there is a need to develop new and improved analytical methods to characterize biologic products. During this presentation, experts will discuss the latest challenges in biophysical characterization and will present solutions to overcome these challenges.
