Harnessing mRNA as a Readout to Develop Robust BioPotency Assays
Transcriptional 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.
G-CON: The Benefits of G-CON Service Solutions
February 19th 2025Following project close out, the G-CON Service Team will ensure that your PODs continue to function as intended. Service offerings include preventative maintenance plans, spare parts, NEBB certified TAB services (testing, adjusting, and balancing), and expedited support options. Additionally, the Service Team handles all warranty requests and manages data from these activities to drive continuous improvement in our products’ performance across all aspects.
Cleanroom Doors: Tailored Solutions for Seamless Integration and Compliance
February 19th 2025Learn about the customization of cleanroom doors to meet specific operational and design requirements. This paper highlights GCS's ability to tailor door solutions, ensuring seamless integration with existing cleanroom infrastructure while maintaining efficiency, sterility, and compliance with industry standards. With a commitment to quality, compliance, and efficiency, GCS delivers door solutions designed to enhance cleanroom performance and meet the stringent demands of controlled environments.
The Next Generation of Prefabricated Cleanrooms: floorlessPOD
February 19th 2025G-CON’s floorlessPOD is a free-standing structure that provides direct integration with the host facility floor, eliminating the need for ramps, platforms and stairs typically required with prefabricated structures that have integrated floors. With fully integrated MEP, the floorlessPOD is an ideal solution when the cleanroom cannot be structurally supported by the host facility.
