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Monoclonal antibody manufacturing continues to evolve through innovations in engineering, formulation, and biosafety to enhance efficiency, reduce costs, and expand therapeutic impact amid growing demand and biosimilar competition.
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Global regulatory guidance, such as the International Council on Harmonization (ICH) Q5A, requires drug manufacturers to implement measures to prevent, remove, and detect contaminants. Explore the regulatory expectations for the incorporation of alternative methods with a focus on comparability and strategies for easier substitution.
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Whole genome sequencing (WGS) by Next-Generation Sequencing (NGS) offers a faster, sequence-agnostic approach for genetic stability testing compared to existing monitoring techniques. Here, we describe the use of WGS to perform a comprehensive assessment of genetic stability in clonally-derived CHO cell banks using a single method.
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Discover Provise® Clearance Services
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Finding a partner with the capacity to meet your needs in a timely fashion and of superior quality can be a challenge. Learn about Provise® Viral Clearance Services and everything offered to support your clearance needs.
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Elevate Your Biosafety Testing
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Shorter timelines, sensitive detection, and reduced sample volume requirements… all of these are made possible with this rapid methods package featuring the Blazar® CHO animal origin-free panel. Thanks to the combination of 4 rapid assays covering the detection of bacteria/fungi, mycoplasma, viruses, and quantitation of retrovirus-like particles, we are now able to deliver bulk harvest test results in just 14 days, instead of 35 with the traditional test package. Explore the package!
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