Biosimilar Manufacturing solution center
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How AI Is Revolutionizing Quality Management Systems
8/13/2025
The real question isn't whether pharmaceutical companies should adopt AI in their quality systems, but how to implement it effectively and what specific benefits to expect.
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Lean Manufacturing Implementation In Pharmaceutical Injectable Facilities
8/12/2025
This comprehensive analysis examines lean manufacturing implementation challenges and evidence-based solutions derived from leading pharmaceutical organizations.
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Seed Train Intensification Using High Cell Density Cryopreservation
8/11/2025
Streamline your upstream bioprocessing with seed train intensification. Discover how high cell density cryopreservation reduces scale-up time, boosts consistency, and enhances manufacturing flexibility.
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Cell Retention Technology And Specialized Cell Culture Media
8/11/2025
Explore how perfusion technology is transforming upstream bioprocessing by boosting productivity, reducing costs, and enabling process intensification while overcoming cell retention challenges.
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Biotech's Plastic Problem Meets Its Match
8/8/2025
Explore how a partnership with UW–Madison and Genentech developed a breakthrough recycling technology that is poised to reshape single-use bioprocessing sustainability.
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What Happens When You Refuse To Compromise On Sustainability?
8/8/2025
Discover how an empty building shell became a sustainable nanomedicine hub and achieved 47% energy savings and 88% fewer emissions, which sets new standards for innovation in the biologics industry.
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Facts About AAV Producer Cell Lines
8/8/2025
Gene therapies are revolutionizing medicine, with AAV vectors leading the way. As production evolves, stable cell lines may replace transient transfection and unlock scalable solutions.
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Minimizing The Impact Of Human Errors Using Relational Risk Analysis
8/4/2025
This article describes how a mechanism-based risk analysis approach can provide two complementary opportunities for minimizing the likelihood of a human error impacting pharmaceutical and medical device risks.
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The Building Blocks Of A Robust Analytical Assay
8/1/2025
Analytical assays aren't just important for quality control. Regulators expect them. These tips will help if you're just starting to build your analytical package.
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Environmental Monitoring Performance Qualification In New Drug Manufacturing Facilities
8/1/2025
In setting up a new manufacturing facility, a robust process for environmental monitoring must be established and cleanrooms in the classified areas must be properly qualified. Here are critical considerations to keep in mind.