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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Article
The Unique Challenges of Lipid Nanoparticle Development and Manufacturing
The use of lipid nanoparticles (LNPs) as non-viral delivery tools for messenger RNA (mRNA) helps alleviate the otherwise poor pharmacokinetics (PK) and in vivo instability of mRNA. However, LNP formulation development and manufacturing remains complex and challenging.
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Article
Article: mRNA Development & Manufacturing: CMC Challenges & Solutions
The demand for mRNA-based vaccines and treatments has increased significantly, and the industry has been challenged to not only meet these needs, but also improve existing manufacturing processes and efficiencies.
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Article
Article: mRNA: A New Option for Vaccines & Therapies
The use of mRNA for vaccines & therapeutics is being explored due to the advantages that the technology presents, and the promise of mRNA was demonstrated by COVID-19 vaccines, which provided a pathway for future therapeutics to employ this technology.
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Webinars
Webinar - Development of Orphan Biologics: Challenges and Opportunities
In this webinar experts cover aspects of clinical trial design for orphan biologics products, key strategies for ensuring clinical trial supply throughout clinical development and the regulatory and legislative framework for delivery to patients.
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