Search results for " production"
Article
New Era for Generic Drugs
Manufacturers say such communication is key to resolving problems quickly and helps them plan for production changes and product launches. FDA officials maintain that constant queries are a burden, le…
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Evaluating Design Margin, Edge of Failure and Process
In this respect, limits are justified based on critical information gained from the entire process spanning the period from early development through commercial scale production.”
Table I: Measu…
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Global Expansion Shapes Drug Oversight
Few FDA officials discuss pharmaceutical regulation these days without reference to how the international reach of the biopharmaceutical industry has altered drug research, production, and regulation.…
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Early Communication with Regulators is Essential for SMEs
“We want to encourage SMEs to come to a regulator as soon as possible in the development work so that they get the production process right from a regulatory perspective early on,” explains Lars Dager…
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The Future of Biopharma
Many are relying on suppliers' innovations to advance production processes for current biologics, emerging biosimilars products, and for the production of biologics in emerging markets using flexible …
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A Diverse Landscape of Patent Issues Seen in the US, UK, and the EU
…tection of expired product patents, so most of the litigation has been over process patents for drug production. This situation is expected to change (but not in the short term), as new biologic drug…
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Using Software in Process Validation
Conclusion
Validation is used in the process design stage through commercial production and can provide the scientific evidence that a process can consistently result in delivering a quality prod…
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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
In this 41st article in the Elements of Biopharmaceutical Production, the authors present the basics of SPR as well as the various applications it offers in biopharmaceutical analysis.
Various me…
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CMOs Concerned With Cost of Single-Use Equipment
The top two concerns for each group, for example, were “breakage of bags and loss of production” and “leachables and extractables”, with the former the most widely held among biomanufacturers and the …
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Selecting a Comprehensive Bioburden Reduction Plan
A combination of orthogonal methods is most effective for minimizing bioburden during production. Culture media treatment by high-temperature–short-time (HTST) or UV-C will reduce microbial load. Filt…