Search results for " quality"
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…
Poster
Opportunities, Challenges, and Economic Drivers for Start-to-Finish Continuous Biomanufacturing
Within the risk profile, assurance of patient safety and supply through product quality demonstration will be critical.
This poster will highlight trade-offs and benefits associated with the adopt…
Resource
Plasma Product Biotechnology Conference
The sessions, compiled from submitted presentations, will cover the areas of manufacturing, quality, regulatory, pathogen safety, clinical development and technical innovations, and will chaired by re…
Poster
Scalable Continuous Chromatography Process for Enhanced Efficiency in Biomanufacturing
The cost pressure on biopharmaceuticals drives the industry toward exploring process intensification options that will maintain or improve quality, stability, and manufacturability of the product wh…
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?
A Plastic Pipeline for Commercial Bioprocessing?
The maturation of single-use technologies presents commercial bioprocessing options for small-volume drug products.
By Rita C. Peters
…
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…
Article
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…