Search results for " manufacturing" in Articles / App Notes
Article
Continuous Manufacturing: A Changing Processing Paradigm
Single-use process technologies took “20 years to be fully adopted and accepted in clinical manufacturing, and they are only just making their way through commercial manufacture,” says Andrew Sinclair…
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Modular Manufacturing Platforms for Biologics
There are modular room enclosure systems (such as from Daldrop, AES, or Plascore); modular room enclosure systems with utility systems (such as from G-CON Manufacturing or SmartFit Modular); building …
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Contract Manufacturing Through the Years
How has the bio/pharmaceutical contract manufacturing industry evolved over the years and what does the future hold?
By Jim Miller
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Bioprocessing Advances in Vaccine Manufacture
As these technologies advance and are increasingly adopted for commercial-scale manufacturing, the industry will see an evolution in vaccine manufacture. Significant improvements are now commonly bein…
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Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
The chemical and physical properties of polymeric materials will be influenced by molecular structure, polymerization process, stabilization and processing additives, as well as manufacturing factors …
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Supplier-Change Management for Drug-Product Manufacturers
As a result, companies making these products perform extensive studies to validate that the materials, equipment, and processes used for manufacturing consistently produce products that meet specifica…
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Continued Process Verification for Biopharma Manufacturing
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Continued process verification (CPV) is the activity that provides ongoing verification of the performance of a manufacturing process. Guidance issued by FDA in 2011 (1) emphasized the impo…
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Manufacturers Struggle with Breakthrough Drug Development
Demonstrating efficacy is not the problem, she noted; the greater challenge is to ensure quality manufacturing and access to needed diagnostics.
CMC issues
FDA grants breakthrough status f…
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A Look Ahead at BioPharma Manufacturing and Regulation
Regulatory science underpins innovation and practices in drug manufacturing. The most common definition of regulatory science is a discipline that creates new tools, standards, and approaches for use …
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2014 Manufacturing Trends and Outlook
In a recent survey of current trends and practices in biopharmaceutical manufacturing, BioPharm International readers revealed a preference for disposable systems, identified challenges for different …