Biosimilar White Papers
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Five Essentials For Accurate Oligonucleotide Chemistry
3/4/2024
Explore five key areas in oligonucleotide chemistry where improvements will have a huge influence on your synthesis quality.
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Sterile Filtration And Quality Risk Management
8/31/2023
Process control is essential for manufacturing sterile products. Explore the role of filtration for bioburden control in quality risk management and contamination control strategies.
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Performance Characteristics Of The MobiusĀ® 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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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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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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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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Strategies For Ensuring Biomanufacturing Resilience For Biologics
6/29/2023
Long-term collaboration in resilient biomanufacturing capacity and supply chains ensures the reliable delivery of health technologies. Investigate biomanufacturing resilience strategies for biologics.
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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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2024 Global Biopharma Sustainability Review
9/3/2024
What steps is the biopharma industry taking to enhance sustainability? What challenges does biopharma encounter? And how can the entire industry draw lessons from the companies setting the standard?
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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.