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Article Unifying Continuous Biomanufacturing Operations
He explains that stable continuous virus production is not possible if the cell and the product (virus) are propagated in the same vessel because viruses are lytic. “For continuous virus production, m…

Article SEC in the Modern Downstream Purification Process
…ize-exclusion chromatography (SEC) has played a significant role in the purifiĀcation of proteins, viruses, enzymes, nucleic acids, and other biomolecules. While SEC may have mostly been abandoned i…

Article Advances in Sterilization Technologies for Overcoming Viral-Vector Manufacturing Challenges
Today, however, the variable nature of viruses (DNA/RNA, enveloped/non-enveloped, size range from 20 nm to 400 nm) and their associated properties (e.g., chemical, physical, and thermal stability) rem…

Article Filtration methods to overcome new challenges in viral safety
41 and ICH Q5A, and outlines the detailed mechanisms governing effective virus filtration, demonstrating how both specific methods and advanced filter design can overcome these challenges. READ FUL…

Article Maximum Output Starts with Optimized Upstream Processing
The severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) outbreak has highlighted the need for high-capacity, scalable technologies for viral vaccine production, adds Chilima. “This outbreak h…

Article Technology Innovations Improve Process Chromatography Performance
Convective flow membrane chromatography and monoliths addressed the previous purification challenges with diffusive matrices for large molecules, such as viruses (> 100 nm), plasmids, or even large pr…

Article New Therapies Present Scaling Challenges
The genetic material to be introduced into the mammalian cell include the DNA that encodes the cell’s machinery to make the virus, which will be the vehicle through which the therapy is delivered, and…

Article Addressing the Complex Nature of Downstream Processing with QbD
These steps are typically designed with more specific product attributes in mind and need more fine-tuning to achieve a goal of product or process related impurity or virus reduction,” says MacDonald.…

Article Development of Purification for Challenging Fc-Fusion Proteins
In this study, utilizing a combination of high-throughput condition screening in 96-well plates, optimization in small-scale column models, and a novel virus-spiking strategy, the authors have develop…

Article Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
But because the chosen methods focused primarily on downstream virus removal or inactivation instead of strategic sourcing of lower-risk starting materials, the efforts had little effect on serum-free…

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