Biosimilar White Papers
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Data Utilization For Advanced Analytics And Near Real-Time Monitoring
8/16/2022
Control, monitor, and analyze equipment, processes, results, and data in near real time and make data-driven decisions at both the process and plant levels.
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Lowering The Lipids Barrier: The Key To Accelerating RNA-LNP Drug Development
12/27/2023
Learn about the drug development hurdles that must be overcome to deliver on the promise of mRNA.
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Impact Of Immunogenicity On Efficacy And Safety Of Biosimilars
2/9/2024
The presence of anti-drug antibodies (ADAs) can affect the effectiveness and safety of biologic drugs. Read why regulatory agencies emphasize the need for extensive immunogenicity evaluation in biosimilar development.
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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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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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Optimizing Lipid Formulations For Targeted RNA-LNP Applications
9/13/2022
Learn about the considerations and challenges of using ionizable lipids, including the 5 types of lipids used for RNA delivery.
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The Dynamic Regulatory Environment Of Drug-Device Combination Products
11/29/2022
Examine the dynamic regulatory environment of drug-device combination products as well as concrete steps to take to navigate regulatory complexities and decrease time to market.
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Eliminating USP <88> In Vivo Animal Bioreactivity Testing For Polymer Characterization
8/25/2023
There has been growing awareness about the environmental and ethical implications of plastics used in bioprocessing. The time for a shift to well-studied, proven in vitro cytotoxicity testing is now.
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Frontiers In Digital Bioprocessing: Modular Plant Automation And Cloud
5/26/2022
As the biopharmaceutical industry is embracing digital transformation and thus evolves in its digital maturity, future-ready concepts will play a leading role in the shift toward bioprocessing 4.0.
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A Scalable Single-Use Two-Step pDNA Purification Process
3/6/2024
Evaluate the performance of a single-use two-step plasmid purification process, and see how it compares to the existing three-step purification method.