Search results for " control" in Articles / App Notes
Article
HTPD: Optimizing a mAb Chromatography Polishing Step
In addition, steadily increasing demands from regulatory authorities for better understanding and control of manufacturing processes put even more pressure on development work. High-throughput process…
Article
Biopharma in 2016: Higher Quality Drugs, Less Expensive Manufacturing
The year ahead is expected to be marked by increased biosimilar development, lower drug prices, and better quality drugs.
The global biopharmaceuticals market was valued at $162 billion in 2014 a…
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Managing Risk in Raw Material Sourcing
…ffect analysis, fishbone diagrams, and fault tree analysis, as well as hazards analysis and critical control point techniques, says Ohri. The company has established sites in the United States, Europ…
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Advancing Single-Use Technology Through Collaboration
Efforts toward standardizing the supplier change control and change notification processes, as well as standardizing user requirements, have also been initiated as joint efforts between end users with…
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A Q&A with Eric Langer: CMOs Embrace New Technology
In comparison, biopharmaceutical innovators sought improved analytical assays and development, control systems, fill-finish services, and downstream PD services.
Why are CMOs early adopters?
…
Article
Generating a Fully Processed Antibody
By controlling the number of retrovector particles accessing the cell, multiple gene insertion can be achieved without any of the traditional amplification steps (8). This was important for this study…
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Managing Biomanufacturing Capacity Expectations
Capacity for complex therapeutics is becoming increasingly difficult to predict.
By Randi Hernandez
Demand for any given new product is typically only known after significant investments h…
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Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
Asking the right questions is crucial to establishing a facility design.
By Peter Genest, John Joseph
The benefits of adopting single-use technologies in the production of biopharmaceuticals…
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Platform Approach Speeds Process Development
Next, a variable number of cultivation parameter screening and optimization studies are performed in controlled bench-scale bioreactors including DoE approaches. Process fixation and process consolida…
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Continuous Processing for the Production of Biopharmaceuticals
The success of continuous manufacturing technologies relies highly on the utilization of real time analytical tools coupled with superior control strategy. The implementation of process analytical tec…