INSIGHTS ON QUALITY ASSURANCE
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Aiming For Success In Early mAb Process Development And Beyond
Developing a monoclonal antibody (mAb) requires strict quality compliance. Building on a strong foundation from the start with a quality by design (QbD) approach is key for success and minimizing variability.
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Closed Sampling: Crucial For Aseptic Processing
Explore the critical role of closed sampling in bioprocessing by gaining insight into regulatory frameworks, system integrity, and aseptic practices essential to ensure compliance and product quality.
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Navigating Technology Transfer In Manufacturing
Technology transfer is essential for scaling life sciences innovation. Learn how teams navigate its complexity, overcome common challenges, and leverage digital tools to improve quality.
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A Strategic Guide For Biotech And Biopharma Leaders
Securing drug approval is a complex, high-stakes process, and outdated review workflows hinder progress. Explore modern solutions that accelerate timelines without compromising compliance or quality.
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How Intelligent Automation Transforms CQV Workflows7/23/2025
Discover how intelligent automation is revolutionizing CQV in life sciences to eliminate manual bottlenecks, accelerate timelines, and enhance compliance in an era of increasing regulatory scrutiny.
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Accelerate Analysis Of Titer, Process Impurities, And Process Contaminants9/30/2025
Learn how automated immunoassay platforms can accelerate titer and impurity analysis in AAV and LV vector workflows—reducing hands-on time while improving consistency from development through manufacturing.
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Select The Best Analyte: A Guide To Effective Mycoplasma Testing9/24/2025
As you build a Mycoplasma testing strategy to ensure drug safety, there are three analyte types to choose from: live Mycoplasma, RNA, and genomic DNA, each offering distinct advantages.
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Drive Innovation With Validation 4.07/1/2025
Discover how Validation 4.0 can revolutionize your organization by boosting innovation, efficiency, and compliance with strategies that overcome challenges and stay ahead of evolving regulations.
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Early Development Considerations For NCE Success: Quality Systems3/1/2024
Leveraging robust quality systems can improve efficiency throughout the product development lifecycle and help companies avoid unnecessary knowledge and tech transfer, saving both time and cost.
QUALITY ASSURANCE SOLUTIONS
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Are you bogged down by the endless protocols and documentation CSV requires? Do you feel overwhelmed by exhaustive testing but unsure of how to implement CSA?
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Take control of your production by tracking every part, assembly, and batch with precision.
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Whether you're looking to boost performance, enhance your capabilities, or simply get consistent, high-quality results, HyClone™ peak expression medium and HyClone™ prime expression medium are the solutions for you.
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TrackWise® is the world’s leading on-premises QMS software. It brings all your quality processes together in a single place to give you the big picture of your compliance and operational effectiveness.
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Centralized data aggregation and advanced visualization streamline compliance reporting and batch documentation. Discover a solution that enables rapid integration of diverse equipment and improves efficiency.