Search results for " Biopharm"
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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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Determining Criticality–Process Parameters and Quality Attributes Part III: Process Control Strategies—Criticality throughout the Lifecycle
Peterson, J Biopharm. Stat. 18 (5) 959-975 (2008).
6. ASTM, E2500-07, Standard Guide for Specification, Design, and Verification of Pharmaceutical and Biopharmaceutical Manufacturing Systems and E…
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Determining Criticality, Part Two: DoE and Data-Driven Criticality
Mitchell, BioPharm International 26 (12) 38-47 (2013).
Mark Mitchell is principal engineer at Pharmatech Associates.
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Operational Excellence: More Than Just Process Improvement
However, that approach forgoes the improvements in efficiency, reliability, and the reductions in costs biopharmaceutical organizations can ill afford to sacrifice. And the result of gold plating will…
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Regulatory Challenges in the QbD Paradigm
This article is part of a special section on biopharmaceutical trends.
With the dawn of the 21st century came the realization that changes must be made by both the pharmaceutical industry…
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Welcome to the new Process Development Forum
Process Development Forum is a joint venture between Cytiva and BioPharm International magazine. Our team welcomes you to the site; please let us know what you think. We welcome your feedback.
The…
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Flexibility in Biopharmaceutical Manufacturing
Compared to other industries, biopharmaceutical supply chains have been stuffed with inventory that effectively decouples manufacturing supply from customer demand. This makes the job of running the p…
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Quality Considerations for Using AI in Bio/Pharma
The use of artificial intelligence (AI) is seeing a surge in a variety of industries. But does the regulated nature of bio/pharmaceutical development, manufacturing, and commercialization ser…
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Downstream Process Developers: What are Your Antibody Processing Challenges?
Process developers, we want to hear from you! We're asking PD scientists to tell us about their biggest challenges developing downstream processes for mAbs and their variants.
Take this …