Offering Fact Sheet
Biologics Analytical Services - Bioassays
Summary: Catalent offers a comprehensive suite of bioassay development services for traditional biologics and advanced therapies, such as antibody-drug conjugates (ADCs), cell and gene therapies, and mRNA vaccines.
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Video
UpTempo℠ AAV Platform Process Accelerates Time From Gene To Clinic
Catalent's UpTempo AAV platform process offers clients accelerated timelines for producing their clinical materials. The scalable, CGMP-ready platform process can significantly reduce the time from gene to clinic through a simplified supply chain.
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Webinars
One-Stop Integrated Viral Vector Platform for Speed to Clinic
Catalent experts discuss UpTempo℠ AAV, a one-stop integrated viral vector platform for speed to clinic. Discover how implementing the right process, utilizing a clonal HEK293 cell line, and leveraging a range of off-the-shelf plasmids, along with qualified analytical methods, can support a robust supply chain for the development and manufacture of AAV vectors.
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White Papers
Improving Methodologies for iPSC Manufacturing & Differentiation
Learn about pluripotent stem cells and how they're being explored as an exciting alternative gene therapy technology with the potential to transform the field of
regenerative medicine.
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White Papers
Bridging the Gap Between Promise and Practicality: Cell and Gene Therapy Advancements, Challenges, and the Path to Commercial Success
In recent years, the field of gene therapy has witnessed remarkable achievements and advancements. These breakthroughs have brought us even closer to unleashing the full potential of gene therapies. Catalent gene therapy experts discuss all aspects of gene therapy commercialization in depth.
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Poster
Poster: GMP Compliant iPSC Lines and Immune-Oncology Platform for Allogeneic Cell Therapy
A poster presentation of a GMP manufacturing process for the creation of human iPSC for use in allogeneic cell therapy applications.
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Poster
Poster: Fully Closed, Scaled, Automated Analytics-on-Boarded GMP Compliant CAR-T Platform
A poster presentation of the UpTempo CAR-T Manufacturing Platform.
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Executive Summary
Executive Summary - Process Optimization for Monoclonal Antibody (mAb) Commercial Manufacturing
Learn how Catalent took to a monoclonal antibody (mAb) from clinical to commercial phase under a highly compressed timeline.
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Webinars
Annex 1: A Guide to EMA’s New Sterile Product Manufacturing Requirements
Watch this expert panel discussing the increased emphasis on risk management and contamination control strategies across the industry.
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Webinars
CGMP-Compliant iPSC Manufacturing and Development of Differentiated Cells for Advanced Therapies: Strategies and Challenges
In this webinar, experts discuss the current state-of-the-art for iPSC generation and differentiation. The presentation will also highlight the development of advanced CGMP-compatible protocols for converting these cells into several cell types of therapeutic relevance, including retinal pigment epithelium (RPE), mesenchymal stem cells (MSCs), cardiomyocytes (CMs), and immune natural killer (NK) cells.
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