Executive Summary
Webinar E-summary UpTempo℠ Antibody: A Streamlined Platform Process to Accelerate Biotherapeutics from Gene to Clinic
Catalent’s UpTempo℠ Antibody platform process combines the industry-leading GPEx® cell line development technology with streamlined, phase appropriate drug substance development to deliver products from early-stage development through CGMP manufacturing.
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Executive Summary
A Guide to Optimizing Analytical Strategies Throughout the Biologics Development Life Cycle
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 their biologic nature, the variable material inputs provide a challenge.
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Executive Summary
Quality by Design (QbD) for Biologics from a CDMO Perspective
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 their biologic nature, the variable material inputs provide a challenge.
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Executive Summary
Catalent’s Advanced Bioassay for Evaluating Cell Response
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 their biologic nature, the variable material inputs provide a challenge.
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Article
Article: Unveiling the Critical Pathways in AAV Potency Evaluation and Future Trends in Gene Therapy
In this expert roundtable, three experienced professionals from the rapidly evolving gene therapy field delve into the crucial assessment of AAV potency and its profound influence on the industry's progress.
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Video
Video: Unveiling the Critical Pathways in AAV Potency Evaluation and Future Trends in Gene Therapy
In this expert roundtable, three experienced professionals from the rapidly evolving gene therapy field delve into the crucial assessment of AAV potency and its profound influence on the industry's progress.
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Webinars
UpTempo Antibody: A Streamlined Platform Process to Accelerate Biotherapeutics from Gene to Clinic
Watch this webinar to find out how UpTempo Antibody addresses key challenges bringing antibody therapeutic programs to clinical trials.
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Video
Roundtable: Cell and Gene Therapy Manufacturing Panel at Advanced Therapies Week 2024
Catalent expert George Buchman, Ph.D., offers insights on key challenges with scaling up production for gene therapies, complexities in the supply chain, regulatory considerations and overall reflections on the industry, progress and future.
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Article
Article: What Strategies are Being Employed to Accelerate Product Development and Commercialization Without Compromising Quality
Summary: In this article, Catalent expert Victor Vinci discusses what strategies are being employed to accelerate product development and commercialization without compromising quality.
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Article
Article: How Cell and Gene Therapy Manufacturing Will Evolve in 2024
Summary: In this article, Catalent expert Rupa Pike to discusses the manufacturing requirements for a specific cell therapy gaining popularity: CAR T cell therapies.
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