Search results for " manufacturing"

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…

Article 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 …

Article 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 …

Article 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…

Article 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 …

Article Challenging the cleanroom paradigm for biopharmaceutical manufacturing of bulk drug substances
Facility design and control considerations for commercial biopharmaceutical manufacturing processes include environmental controls (e.g., temperature, humidity, and pressure), air quality (e.g., parti…

Article 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…

Article Continued Process Verification for Biopharma Manufacturing
48-52  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…

Article 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…

Article 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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