Search results for "quality" in Articles / App Notes
Article
Perfusion Culture Using TFF or ATF as Cell Retention Method
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Perfusion processes have many advantages such as being favorable for product quality and supporting efficient facility utilization by offering the possibility…
Article
Digital Technologies Aid Productivity and Growth
By applying remote monitoring solutions, advanced modeling, and optimization of manufacturing processes, digitalization can offer improved process reliability and product quality through the unlimited…
Article
A Plastic Pipeline for Commercial Bioprocessing?
Quality and performance
“Clients sometimes have a predisposition to one manufacturer or another based on cell performance or other factors,” says Hughes. “We’ve been pretty successful in moving pr…
Article
FDA Seeks to Enhance Manufacturing of Cell and Gene Therapies
This update of a 2008 advisory describes how manufacturers should provide sufficient CMC information to assure the safety, identity, quality, purity, and strength/potency of investigational gene thera…
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Sensitive and Reproducible SPR-Based Concentration and Ligand-Binding Analyses
Surface plasmon resonance (SPR) assays are used across the life cycle of a biopharmaceutical, from target identification, through CQA determination, development, and on-going quality control. This art…
Article
Challenges in Cell Harvesting Prompt Enhancements
Challenges in Cell Harvesting Prompt Enhancements
Higher cell titers and cell densities have posed a challenge to cell harvesting, a crucial step in biologics manufacturing.
By Feliza Mi…
Article
Understanding Validation and Technical Transfer, Part 2
The quality assurance department must be involved at all phases of protocol development and must approve the final protocol before validation begins.
Protocols fit two broad categories. Qualifi…
Article
CDMOs Driving Emerging Bio/Pharma Success
Without the access to CDMOs, companies would need to invest at least $10 million in facilities and a similar amount on manufacturing, analytical, and quality professionals. It would take at least two …
Article
Putting Viral Clearance Capabilities to the Test
“Virus spike quality can influence the operation of key steps; for example, higher purity virus spikes are required for virus reduction filters to minimize virus induced flux decay and achieve the tar…
Article
FDA Framework Spurs Advanced Therapies
As importantly, she notes that FDA must be aware that some of the well-established manufacturing and quality systems used to support the production of well-established medicinal products may not alway…