Search results for " report" in Articles / App Notes
Article
Using Quality by Design to Develop Robust Chromatographic Methods
• Purity: The procedure must be able to accurately quantify all related impurities relative to examplain HCl in the presence of drug substance and other impurities over a range from the reporting thre…
Article
Early Communication with Regulators is Essential for SMEs
…tion, the setting of specifications, and stability data,” says the SME Office in its latest annual report (1). The agency’s SME Office has been disappointed with the low uptake of services from SMEs …
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Operational Excellence: More Than Just Process Improvement
Deviation reports were made the responsibility of a single investigator with specific analytical and investigation reporting skills. The reports were then designed to connect the event and its root ca…
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Elucidating Biosimilars Characterization
Compare this compound with the monoclonal antibody trastuzumab, which has a reported chemical formula of C6470H10012N1726O2013S42 and a molecular weight of 145531.50 g/mol, approximately 260 times the…
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Sterilization Trends for Single-Use Consumables
Single-Use Consumables Global Market Report 2024. January 2024. https://www.thebusinessresearchcompany.com/report/single-use-consumables-global-market-report
Precedence Research. Single-Use Con…
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Pandemic Alters Policies and Practices for Drug Development and Regulation
FDA officials relied more on past inspection reports, current documents from manufacturing sites, and inspection reports prepared by trusted foreign regulatory authorities and shared under mutual reco…
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Reimagining Affordable Biosimilars
A majority of switching studies for biosimilars have not reported any new adverse events, and similar experience has been reported by researchers all over the world (19). Such results fail to justify …
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Maximizing the Effectiveness of Upstream Bioprocessing Through the Combination of Lab Informatics and Instrumentation
As a result, according to a report by Research and Markets, the global single-use bioprocessing market is expected to reach approximately $7 billion by 2024, growing at a compound annual growth rate (…
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Leveraging Computational Models of Glycosylation for Biopharma QA
Presence of α-1,3 galactose residues has been reported to cause fatal anaphylaxis in patients treated with Cetuximab (Erbitux, Bristol-Myers Squibb/Merck) (9,11). These cases occurred in patients who …
Article
Ensuring Viral Safety of Viral Vaccines and Vectors
Extraneous vesiviruses, however, have recently appeared in bioreactors (2–5), and porcine circovirus type 1 (PCV-1) contamination of oral rotavirus vaccines was first reported by a metagenomics analys…