Search results for " process" in Articles / App Notes
Article
2019 HTPD Conference Is Announced. What Happened Last Time?
HTPD 2019 will cover process development spanning upstream through downstream processing for both mAbs, Ab-like molecules as well as novel biomolecules. Sessions will also include integrated P…
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Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
As such, there has been a critical need for significant improvement in glycosidase manufacturing processes.
Recently, New England Biolabs, a provider of recombinant and native enzymes for molec…
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Modern Manufacturing Key to More Effective Vaccines
… such as exceptions to product characterization and testing procedures, and where certain aspects of process validation could be abbreviated. While FDA licenses only those vaccines supported by adequ…
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Navigating Data Integrity in the Modern Lab
While technology has helped make the preservation of data easier, it is just as important that the people operating these systems are aware of the relevance of each step involved in the process, says …
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What's in Your SOP?
SOPs document the steps of key processes to help ensure a consistent, quality output. SOPs are useful tools for operationalizing, optimizing, and communicating important corporate policies, government…
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Reliability Rooms and the Move to Proactive Supply Chain Management
A cross-functional team from quality, customer logistics, global planning, and affiliate services, facilitated by the global reliability team, has put in place a revised process, simplified procedures…
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Development and Future of Protein A Chromatography Technology: Q&A with Jonathan Royce, Business Leader Chromatography Resins, Cytiva
Increasing upstream titers can make the Protein A chromatography process step the rate-limiting step in downstream purification. Protein A chromatography columns are frequently too large, limiting the…
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Best Practices for Data Integrity
A thought process, for example, may be ‘Now we have production yield and quality data that are reliably collected, and we can trust their integrity. How might we leverage that data to minimize variabi…
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Biosimilars to Drive Modern Manufacturing Approaches
These efforts will be supported by a new agreement on policies for renewing the Biosimilar User Fee Act (BsUFA II), with provisions to streamline the biosimilar development and approval process (1). T…
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A Platform Approach for the Identity Testing of Multi-Component Cell-Culture Media
Similar cell-culture media may be used simultaneously in one or few biological processes at a drug product manufacturing facility. As per Code of Federal Regulations (CFR) 211. 84, each media needs to…