Search results for " patients"
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What Drove Biopharma Development in 2014?
…a flows across the entire life cycle of the drug, and improve overall efficacy and cost-efficacy for patients and manufacturers. So, it is no surprise that half of the top 10 stories read by PDF visi…
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Biopharma Manufacturers Respond to Ebola Crisis
The agency also permitted Tekmira Pharmaceuticals (Vancouver) to treat infected patients with its experimental RNA interference drug by converting a “full clinical hold” to a “partial hold” on a Phase…
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Application of Quality by Design to Viral Safety
A quality-by-design approach defines a range of potential viral contaminants of source materials and can be used to effectively achieve viral clearance.
Oct 1, 2014
BioPharm International
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Challenges and Trends in Biopharma Facility Design
Experts discuss the future of modular manufacturing and the challenges that biopharma manufacturers face in facility design.
Sep 1, 2014
By: Susan Haigney
BioPharm International
Volu…
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Applying GMPs to the BioPharma Supply Chain
Defining best biopharmaceutical practices is necessary to ensure the safety of the supply chain.
Manufacturing biopharmaceuticals carries great responsibility. The drugs produced must be availab…
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Defining Critical Quality Attributes for Monoclonal Antibody Therapeutic Products
An approach for establishing the CQAs of a mAb product by evaluating impact and uncertainty during risk assessment.
A critical quality attribute (CQA) has been defined as “a physical, chemical, …
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FDA Urged to Preserve Biosimilar Naming Conventions
“The organizations who know the most about healthcare delivery agree: departing from the currently accepted INN system will not benefit patients,” said Neas. “Instead, it will upset the very systems n…
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Challenges in Analytical Method Development and Validation
Experts give insight on method transfer, QbD, and regulations for analytical method development and validation for biopharmaceuticals.
The manufacture of biopharmaceuticals presents …
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Novel Vaccine Technologies Meet the Need for Pandemic and Therapeutic Solutions
Finally, unlike vaccines produced in fertilized eggs, cell-culture-derived vaccines can be administered to patients who are allergic to eggs.
Development of Novartis’ technology and constructio…
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Raw Material Variability
The biopharmaceutical industry is developing a new approach to controlling variability in raw materials.
It would seem that raw materials used in bioprocessing operations are a relatively straig…