Search results for " quality"
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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…
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USP Stresses Pharmacopeial Standards at CPhI China
The seminar was designed to explain the latest quality standards and regulatory updates to the more than 120 participants. Topics included global harmonization with industry standards and regulations,…
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Host-Cell Protein Measurement and Control
The amount of residual HCPs in drug product is generally considered a critical quality attribute (CQA), due to their potential to affect product safety and efficacy. Therefore, it is a regulatory requ…
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Re-use of Protein A Resin: Fouling and Economics
Typical parameters that are used for column monitoring include yield, height equivalent to theoretical plate (HETP), impurities in eluate, product quality, and chromatographic profile (19–21). More re…