Search results for " design"
Article
Supplier-Change Management for Drug-Product Manufacturers
Pharmaceutical manufacturers’ change-control systems are designed to ensure that any changes to raw materials, product contact materials, manufacturing methods, product tests, and production equipment…
Article
The use of Xcellerex™ mixing system as slurry tank when packing chromatography columns
Introduction
Xcellerex XDM Quad Mixing System is designed for convenient and efficient mixing of buffer, media, product, and other process fluids (Fig 1). The single-use system eliminates the hass…
Article
Stirring up the fermentation game
Bioreactors designed for production in mammalian culture fall short of meeting these unique requirements, for example in terms of oxygen transfer capacity and temperature control. The Xcellerex XDR-50…
Article
Welcome to the new Process Development Forum
The site is now organized around four main categories:
• Quality by Design
• HTPD
• Biosimilars
• Process Development
Each category features a comprehensive collection of artic…
Article
Flexibility in Biopharmaceutical Manufacturing
Facilities will have to be designed and operated on the assumption that they will change use more frequently.
EMERGING MARKETS
If business growth hinges on rapid facility deployment for the…
Article
A Look Ahead at BioPharma Manufacturing and Regulation
The FDA talks about the changing scope of regulatory science.
Regulatory science underpins innovation and practices in drug manufacturing. The most common definition of r…
Resource
FDA’s Adverse Event Reporting System (AERS)
The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA's post-marketing safety surveillance program for all approved drug and therapeutic biolog…
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