Search results for " control" in Articles / App Notes
Article
Analyzing Proteins Using SEC, MALS, and UHPLC
In addition, Pothecary says that characterization of oligomers, which are ordered assemblies of multiple proteins, is important because oligomerization controls protein activity. Measurement of molecu…
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Global Expansion Shapes Drug Oversight
…SP to provide technical assistance to government regulatory systems in establishing domestic quality control laboratories, quality monitoring systems, and effective domestic regulatory authorities.
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Biopharma Moves to Integrated, Single-Use, Downstream Processing
On the smaller scale, Masser also notes that scrutiny by FDA and internal quality control becomes more intense the closer a process step is to the final therapeutic, and as a result there have histori…
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Q&A with Industry Leader Konstantin Konstantinov, Genzyme Vice-President
Furthermore, continuous processing facilitates quality control. For instance, many therapeutic proteins are insufficiently stable for batch processing. But with continuous processing, once the protein…
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Quality by Design—Bridging the Gap between Concept and Implementation
The drive to embed quality-by-design (QbD) principles into the pharmaceutical regulatory framework of the European Union has reached a key point 10 years after the European Medicines Agency (EMA) firs…
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2014 Manufacturing Trends and Outlook
Survey respondents represented research, development, formulation, and process development functions, as well as quality control/assurance, validation, and laboratory management titles at branded and …
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Climate Change in Outsourcing
POC is leading to specialization in the CMC (chemistry, manufacturing, and controls) development sector, with smaller CDMOs specializing in the ability to fulfill CTM requirements relatively quickly a…
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The use of Xcellerex™ mixing system as slurry tank when packing chromatography columns
The system is complete with motor and controls, and an irradiated USP Class VI, single-use, low-density polyethylene plastic bag equipped with a disposable bottom-mounted impeller. The connection betw…
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Prescribing Caution for Biosimilars
They are also a necessary measure to ensure that patients and their physicians remain in control of their medical treatment decision-making as the market for complex biologics evolves over the next se…
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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…