Search results for " system" in Articles / App Notes
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Your Protein Purification Questions Discussed with Cytiva R&D Scientists
In the web chats, ÄKTA system users are offered the opportunity to discuss their questions--related to lab-scale protein purification and ÄKTA systems--with an expert panel of Cytiva R&D sci…
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Simplify chromatography method creation
In this blog post, you can read about tips and tricks to simplify method creation as well as useful system functions that might have been forgotten.
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Biosimilars: Making the Switch Comes with Challenges
The differences were due to the presence or absence of strong national champions of the biosimilar versions, national tender systems, incentives to prescribers, and fragmented decision making within c…
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Vaccine Development Faces Urgency and Challenges
The extensive process was needed to document unchanged quality attributes of the adjuvant under a new automated quality control system.
Similarly, Wilson Forsyth, director of quality control at As…
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Framing Biopharma Success in 2016
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Biopharma in 2015: A Year for Approvals and Innovations
…nal antibody
Highly efficient inoculum propagation in perfusion culture using WAVE Bioreactor™ systems
The Use of Dynamic Control in Periodic Counter-Current Chromatography
Purification Str…
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FDA Releases Draft Guidance on Emerging Manufacturing Technology
FDA stated the purpose of the initiative was to “encourage the implementation of a modern, risk-based pharmaceutical quality assessment system.”
In 2004, the agency released an additional guidance…
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CMOs Continue to Improve Overall Biomanufacturing Performance
These range from better analytical testing and product release services to better operations staff training, optimized media and improved existing quality management systems. Better process developmen…
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Selecting a Comprehensive Bioburden Reduction Plan
…n levels, selection of monitoring and detection methods, operator training requirements, and quality system oversight.
BioPharm: What procedure is used to identify the various points in which bio…
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Host-Cell Protein Measurement and Control
The European Medicines Agency (EMA) guideline CPMP/BWP/382/97 states, “In summary, for HCP, whatever the product and production system, residual HCP have to be tested for on a routine basis”…“As such,…