Biosimilar White Papers
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Process Analytical Technology In The ADC Bioconjugation Process
4/23/2025
Integrating Process Analytical Technology into validated GMP processes is complex and costly, which requires thorough validation of equipment and cleaning methods. Explore more about PAT's role in ADC production.
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ADC Development Grows More Complex — SPR Insights Bring Clarity
4/14/2026
Explore how real-time kinetic analysis reveals how conjugation, linker chemistry, and drug loading influence antibody–antigen interactions, while enabling sensitive detection of anti-drug antibodies.
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Performance Characteristics Of The Mobius® ADC Reactor For Conjugation
10/22/2024
Explore results from a series of studies evaluating the mixing performance of an innovative ADC reactor during the conjugation step utilizing a model fluid.
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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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A Risk-Based Approach To Plasmid DNA And mRNA Process Development
9/23/2025
Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.
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Aseptic Process Design And Simulation Under Annex 1 Guidelines
1/9/2026
Gain insight into how Annex 1 reshapes aseptic process validation, as well as into risk reduction by design and why isolators are redefining modern sterile manufacturing standards.
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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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Process Intensification And Other Ways To Adapt To Changing Needs
7/20/2026
As biologics manufacturing evolves, gain insight into why productivity depends on smarter investments, flexible production strategies, and supplier support that can address shifting modalities.
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Aggregation In Antibody-Drug Conjugates: Causes And Mitigation
9/1/2025
Discover how early intervention in ADC development can streamline clinical progress, ensure stability and safety, and accelerate commercialization with expert guidance.
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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.