Catalent

Catalent has developed a cutting-edge bioassay using real-time quantitative reverse transcription (RT-qPCR) in a duplex format to measure transcription activity in cells treated with ligands or transgenic vectors. This reliable and reproducible assay is a valuable tool for evaluating the relative potency of various test substances. Enhance your research with Catalent’s robust cell-based potency 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.

The manufacture of protein-based drugs is complex and relies on using biological host systems. This can result in small changes in protein structure during production and formation of protein variants that can have a large impact on functionality. This heterogeneity — variations in the protein size, charge or structure — can significantly impact the safety and activity of the final biotherapeutic or biosimilar therapy, potentially hindering their beneficial effect. It is vital that charged variant profiles of biologics are adequately characterized, as many post-translational modifications (PTMs) may alter the charge of the molecule, in turn impacting its stability, pharmacokinetics and pharmacodynamics. In this article, Catalent explores protein variants, focusing on charged variants, by outlining their impact on protein-based drugs, and explain how specific characterization techniques can be used to determine product safety and efficacy.

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. Notably, the assay simplifies the process by eliminating the need for mRNA purification, enabling more efficient and accurate analysis. Normalizing the qPCR cycle thresholds (CT) of the target transcript to the reference transcript allows the 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 the comparison of relative potency and assessment of suitability based on curve parallelism. Catalent has successfully implemented this assay platform to develop a reliable, accurate, and specific bioassay. It stands out for its linear response and reproducibility, making it a valuable tool for evaluating the relative potency of various test substances. Join us to explore how these robust cell-based potency assays can enhance your research and provide critical data on drug product potency.

Biophysical 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.

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.

Webinar Date/Time: Thu, Dec 5, 2024 11:00 AM EST

Cell-based assays (CBAs) are key tools for evaluating the potency of new biologic drugs. Catalent’s transcription-based bioassay simplifies and empowers the testing of new biologics.

Harmonizing technological innovation and a platform approach in biomanufacturing can reduce time and cost barriers to produce stable, high-expressing antibody-based therapeutics.

By integrating QbD into the development process, organizations can achieve robust manufacturing processes, regulatory compliance, and commercial success.

Webinar Date/Time: Thu, Oct 31, 2024 11:00 AM EDT

Webinar Date/Time: Wed, Oct 16, 2024 11:00 AM EDT

Implementing automation involves careful optimization and fine-tuning of various parameters to ensure the accurate execution of cell-based potency assays.

Webinar Date/Time: Thu, Apr 25, 2024 11:00 AM EDT

Webinar Date/Time: Wed, May 8, 2024 11:00 AM EDT

Webinar Date/Time: Wed, Feb 28, 2024 11:00 AM EST

Webinar Date/Time: Thu, Dec 14, 2023 11:00 AM EST

Shorten clinical development timeline using novel GPEx® Lightning cell line development technology.

CDMO Catalent’s UpTempo℠ adeno-associated viral (AAV) platform process accelerates time from gene to clinic.

Catalent provides fill/finish services in a range of formats to support clinical and commercial products.

Shorten clinical development timeline using novel GPEx® Lightning technology

Catalent’s UpTempo Virtuoso™ AAV platform accelerates development, delivering clinical material in 9 months.

OneBio® Suite is an integrated solution for biologics development that reduces timelines, risk and complexity.

Catalent provides fill/finish services across a range of product formats from clinical to commercial scale.

Interest in mRNA as a therapeutic modality has exploded since the approval of mRNA-based COVID-19 vaccines.

Perfusion technology is a tool to increase productivity that can be applied at different stages during upstream cell culture for biotherapeutics products. Perfusion allows removal of waste by-products and replenishment of fresh nutrients so that the cells are able to grow and reach higher cell densities and higher productivity. N-1 perfusion, the application of the perfusion technology in the step immediately before the production bioreactor, is a good option for processes that exhibit low productivity. Join Claudia Berdugo, Ph.D., Director of Process Development at Catalent Biologics, for a podcast where she discusses N-1 perfusion and how Catalent Biologics works toward process improvements for each client to enable them to move their pharmaceutical products forward with confidence.

Catalent’s GPEx® Lightning provides next-generation cell line engineering to accelerate development of biologic molecules.

Catalent Cell & Gene Therapy is a full-service partner for plasmid DNA, viral vectors, and autologous and allogeneic cell therapies.

In this podcast, Catalent Biologics regulatory expert, Kelly Davis shares her insights on why companies choose to repurpose drugs, what the main considerations are when doing so, how companies can overcome the challenges they face, and how Catalent supports companies going through this process.