| | | Leveraging Novel Analytical Approaches for Advanced Therapies |
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| | | | 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) 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. |
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| | 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. |
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| Automating Cell Based Assays: Reducing Variability and Time to Results |
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| | Cell-based assays play a critical role in assessing potency for traditional biologics and advanced therapeutics. For all analytical methods, increasing accuracy and precision while decreasing variability are critical to optimizing a method. For a cell-based assay, due to biologic nature, the variable material inputs provide a challenge. Therefore, other aspects of the analytical method need to be assessed for improvement opportunities. |
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| | Removing variability through automation can help increase assay robustness and ruggedness, as well as reduce time to achieve results. In this presentation, the development of a cell-based potency assay on an automated platform is discussed. |
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| Reliable Analytical Services to
Advance Your Biologic |
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| | Catalent offers a comprehensive suite of analytical services for traditional biologics and advanced therapies such as antibody-drug conjugates, cell and gene therapies, and mRNA vaccines at our Kansas City, Missouri and RTP, North Carolina sites. With over 30 years of experience, our seasoned scientists stand ready to provide you with reliable analytical solutions including: |
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Method Development & Phase-Appropriate Validation -
Stability Studies -
Physical & Compendial Testing -
Cell Bank & Characterization -
Binding & Cell-Based Assays -
Molecular Biology -
Extractables & Leachables -
Reference Standard Characterization & Aliquoting
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| Looking to Connect at an Upcoming Event? |
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| | We look forward to meeting you at our upcoming events to discuss your program needs. |
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| | BEBPA US Bioassay: March 11-13 | Long Beach, CA, US DCAT: March 18-23 | New York, NY, US CASSS Bioassay: April 15-17 | Gaithersburg, MD, US AAPS National Biotech Conference: May 13-16 | San Francisco, CA, US BIO International: June 4-8 | San Diego, CA, US |
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| | | Every program has a challenge. We have a solution. |
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| | | | or call +1 877 891 9609 to speak with one of our experts today! |
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| For more information call +1-866-720-3148 or in Europe 00800 88 55 6178, email us at sales@catalent.com, or visit our website www.catalent.com. And to learn more about Career opportunities across our global network, visit www.catalent.com/careers.
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© 2024, Catalent Pharma Solutions, Inc. 14 Schoolhouse Road, Somerset, NJ 08873. All rights reserved. |
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