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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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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Article
Article: Streamlining Process Characterization Toward Successful Validation Campaigns
Understanding processes in the development and manufacture of biological drug substances is crucial to successfully navigating the clinical phases towards commercial launch, all within ever‑tightening time constraints, and regulatory frameworks.
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Offering Fact Sheet
UpTempo℠ Antibody Platform Process
Summary: A single solution integrating development through complete clinical supply to simplify, accelerate and de-risk your monoclonal antibody (mAb) development.
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Webinars
Webinar – Process Optimization for Monoclonal Antibody (mAb) Commercial Manufacturing
In this webinar, experts will discuss the evolution of protocols associated with induced pluripotent stem cell (iPSC) generation and differentiation.
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Video
GPEx® Lightning: The Latest Cell Line Development Technology
Summary: Leveraging Catalent’s proven GPEx expression platform in a glutamine synthase (GS) knock-out Chinese hamster ovary (CHO) cell line system, GPEx Lightning combines innovative technologies, including a novel gene insertion technology, to further shorten drug substance development by up to three months compared to previous timelines.
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Video
Choosing a CDMO Partner for Your Late-Stage and Commercial Biologics Programs
Summary: Learn more on considerations for choosing the right CDMO for your late-stage biotherapeutics programs in this interview with Stacey Treichler, Ph.D., Director, Head of Marketing & Strategy, BioModalities, Catalent Biologics.
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