Outsourced Pharma White Papers
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Navigating The Regulatory Maze: Fundamentals For Drug Development
7/15/2022
Learn about key regulatory concepts and ways to accelerate and reduce risk throughout the drug development journey.
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Switching To Direct-To-Patient Rapidly In The EU
10/4/2022
Explore the logistical risk management factors to consider when deciding to switch to direct-to-patient shipments in the EU.
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GMP-Validated Adventitious Virus Testing By Next Generation Sequencing
6/6/2022
Gain required knowledge related to the involved regulatory authorities and scientific technologies and disciplines: Next Generation Sequencing (NGS), Bioinformatics and Computer System Validation (CSV).
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Using Next Generation Sequencing Methods For Virus Vector Identity Testing
9/7/2022
Sequencing techniques play a crucial role in establishing the quality attributes of a variety of therapeutic products. Learn what advantages NGS offers for obtaining accurate sequences.
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Establishing Analytical Methods For mRNA-Based Therapies
6/13/2023
Here, we provide a detailed description of assays for sequence identification and LNP composition in mRNA-LNP products that support the development of safe and effective mRNA therapies.
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Streamlining And Standardizing Cell And Gene Therapies From Process To Product
1/13/2023
Cell and gene therapies are transforming the lives of patients with various rare genetic diseases and more common conditions such as cancer. However, the rapid pace of scientific progress has overwhelmed supply infrastructure, creating pressures to scale manufacturing, increase capacity and meet a wide range of deliverable requirements.
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Fc-fusion Cell Line Development: Expression And Analytical Strategies
5/15/2023
Understand high titer expression of Fc-fusion proteins using the Apollo™ X platform coupled with integrated quality assessments, enhancing support through the predicted growth in Fc-fusion clinical applications.
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Accelerating The Development And Production Of High-Quality Bispecific Antibodies
3/7/2024
bsAbs are revolutionizing medicine by targeting two disease mechanisms simultaneously. Learn how an innovative platform offers excellent pairing and significantly enhances productivity and quality.
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Vial Breakage During Lyophilization: Root Causes And Mitigation
12/12/2023
Learn how controlling freezing rates, using specialized vials, and employing optimized stoppering techniques can reduce the risk of vial breakage during lyophilization and ensure high product quality.
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Manufacturing Challenges With High Concentration Biologics
3/18/2024
Explore key process operations, some of the challenges in manufacturing high-concentration biologics, and factors to consider for process optimization.