Biosimilar White Papers
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Advancing A LNP Formulation To Clinical And Commercial Manufacturing
3/25/2024
Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.
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Assessing A Targeted Molecular Method Against Traditional In Vitro Testing For Adventitious Virus Detection
10/3/2024
Discover a CHO AOF panel that provides rapid detection of relevant adventitious viral contaminants in bulk harvest material, and explore data showing equivalent sensitivity to the in vitro assay.
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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.
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The State Of Plastics Recycling In BioPharma
8/9/2023
Recycling plastics from biomanufacturing proves uniquely difficult due to circularity, quality, and infrastructure challenges. Nonetheless, change is underway. Learn how this change is being spearheaded by industry leaders.
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Business Continuity Management: The Benzonase® Endonuclease Success Story
8/21/2024
Business continuity management is a key success contributor to the pharma industry. Explore best practices for a robust supply chain and how they can translate into success stories.
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How Can The Industry Drive Down The Cost Of Viral Gene Therapies?
4/5/2023
This article discusses how a combination of optimizing your process development, and process intensification can help drive the cost of dose down.
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The Advantages Of A Blended Learning Approach In Operator Training
5/30/2024
Explore blended learning and its advantages over traditional operator training methods, which often reduce training to a repetitive but necessary checklist of reading and acknowledging procedures.
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Single-Use Multi-Layer Film Delivers Comparable Cell Growth Performance To Glass
5/12/2023
Explore the findings of studies analyzing the performance of upstream bioprocessing with Ultimus® film, a single-use, multi-layer film with a fluid contact layer free of Irgafos® 168.
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Controlling Trace Impurities In Chemically Defined Media
4/10/2023
Discover a novel approach for manufacturing chemically defined media with precision control of trace impurities that utilizes innovative raw material analysis, data analytics, and a proprietary algorithm.
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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.