Biosimilar White Papers
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Perfusion Cell Line Development For Intensified Processes
5/5/2025
The biopharmaceutical industry is transforming by shifting to continuous and intensified upstream bioprocesses, which are driven by evolving demands. Discover the key goals and innovations shaping this transition for modern healthcare.
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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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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.
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Optimizing Safety Measures For rAAV Therapies
10/11/2024
Explore common process-related impurities found in recombinant Adeno-Associated Virus (rAAV) vectors and the analytical testing methods used for these residuals.
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Considerations For Developing The Recirculation/Perfusion Process
6/6/2024
Learn about the recirculation and perfusion processes made possible by single-use, fixed-bed bioreactors designed for scaling up adherent cell culture processes.
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Is Sustainability The Key To Agile Biopharma Manufacturing?
3/18/2025
In biologics manufacturing, change is constant. Discover how new innovations and a focus on sustainability have gotten 62% of executives to prioritize eco-friendly practices, which reflects a commitment to long-term viability.
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Innovation In Filtration
3/18/2025
Filtration removes contaminants to ensure safety and is essential in various applications, from lab-scale tasks to GMP production. Explore how its simplicity and reliability make it indispensable.
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Regulatory Considerations For Excipients Used In Lipid Nanoparticles
8/15/2024
Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.
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A Supplier-Manufacturer Approach To Mitigating Nitrosamine Risk
10/10/2024
Learn about how nitrosamines are formed, their prevalence and chemical precursors in pharmaceuticals, techniques for quantification, and approaches for managing nitrite impurities.
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Biologics Technology Transfer Guidebook
2/26/2025
Explore why technology transfer is a critical component in mammalian biologic drug development and manufacturing with the essential guide to biologics tech transfer that covers key strategies, best practices, and critical considerations.