Search results for " biopharmaceutical"
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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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Biopharma Moves to Integrated, Single-Use, Downstream Processing
Drivers for adoption
The success that biopharmaceutical manufacturers have had with single-use technologies for upstream applications is providing significant impetus for their application to down…
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Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
“The Sf9/BV genetic engineering technology is now well established in the biopharmaceutical industry, and has for example been used for the production of a licensed human papilloma virus vaccine and a…
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
“Since 2002, we have made significant investments in facilities, human resources, and technology to become a global and innovative biopharmaceutical company,” he says.
Need for clear regulatory pa…
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Manufacturers Struggle with Breakthrough Drug Development
Accelerated testing and production create challenges in documenting product quality.
Biopharmaceutical companies are eager for FDA to designate potential test therapies as “breakthrough drugs…
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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
ASTM, E2500-07, Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and Equipment (West Conshohocken, PA, 2012).
7. PDA, Techni…
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Report: Branded Biopharms Most Exposed to Biosimilar Competition
In a new report on the global biosimilar drugs market, Biosimilars: Parsing the Industry's Pipelines, Moody's Investors Service reports that while biosimilar products have been launched in Asia and …
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Predicting Progress in Protein Aggregation
As a result, there is increasingly regulatory pressure for biopharmaceutical manufacturers to reduce the risk of immunogenicity by not only controlling, but also preventing, aggregate formation.
…
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Drugs, At What Cost?
…f, and varying medical and regulatory practices worldwide continue to shape the financial outlook of biopharmaceutical companies.
In a new report, The Global Use of Medicines: Outlook through …
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Determining Criticality-Process Parameters and Quality Attributes Part I: Criticality as a Continuum
Historically, in biopharmaceutical development, criticality has been a frequently arbitrary categorization between important high-risk attributes or parameters and those that carry little or no risk. …