Search results for " quality" in Articles / App Notes
Article
Ensuring the Biological Integrity of Raw Materials
And there should be a quality assurance system in place with a system for delineation of specific batches. The supplier should have a regular audit routine. (2)
It is impractical to test all raw m…
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Biosimilars to Drive Modern Manufacturing Approaches
OBP Director Steve Kozlowski explained at the Biosimilars Council conference that extensive structural and functional characterization that identifies critical quality attributes, plus adequate clinic…
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Real Time Continuous Microbiological Monitoring
Traditional microbial monitoring within an EM program does not provide an exact quantity and quality of the microorganisms present in the manufacturing area. Numerous studies have shown that there is …
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A Q&A on Bioprocessing Trends and Technologies at INTERPHEX 2016
Did you see any trends in the consumables segment?
The quality and supply of cell-culture media, buffers, and other process liquids was also a popular topic. Demand for custom formulations and pac…
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Designing a Biomanufacturing Facility Incorporating Single-Use Technologies
This approach can have benefits in ensuring consistent standards of quality and reduction of time to first batch. This modular approach to building allows site excavation to run in parallel with modul…
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Lessons Learned Accelerate Vaccine Development
A collaborative approach with all internal and external stakeholders that includes intensive communications can accelerate all aspects of the development effort without reducing quality or safety, acc…
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A Q&A With Jeff Carter on Trends in Single-Use Technologies
This development will lead to the increasing availability of high quality single-use material information which, in turn, will provide greater technical insight to process performance. This will help …
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A Q&A With Günter Jagschies: Recovery of Biological Products Conference Series
Participants from academia and industry meet and discuss the latest developments in an environment away from the daily routines, rich in scientific quality and engagement, and free from commercial dis…
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Changing the Culture of Cell Culture: Applying Best Practices and Authentication to Ensure Scientific Reproducibility
Cell lines are cultured, passaged, and processed in and among laboratories with widely varying quality control (QC) procedures, while sharing cell lines is endemic--particularly in academia. For these…
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CMOs Concerned With Cost of Single-Use Equipment
Cost factors are right up there with product quality, on-schedule delivery, and the provision of L&E data that regulators will accept. However, for this industry, and most others, cost factors are a c…