Leveraging Novel Analytical Approaches For Advanced Therapies
The characterization and analysis of advanced therapies, such as cell and gene therapies (CGTs) can be difficult, as these products are designed to function using complex mechanisms of action (MOA)s. There are a wide range of challenges associated with accurately assessing the potency and impurity profiles of these complex biologicals. As many CGT programs qualify for accelerated review pathways, novel approaches for analysis and characterization can help generate data that allows for real-time decision making and faster development timelines. Catalent has developed a relative potency bioassay using quantitative polymerase chain reaction (qPCR) to assess relative transcription activity in cells treated with ligands or transgenic vectors. The assay platform can be used to qualify a repeatable, accurate, linear, and specific bioassay for assessing relative potency for CGTs, mRNA- and other nucleic acid-based therapies.
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.
