Search results for " standardization"
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Regulatory Requirements for Safe and Efficient Biologic Drug Development
STEVE
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Steven Lynn, Executive Vice-President, Pharmaceuticals, Regulatory Compliance Associates, shares insight into regulatory require…
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The Importance of Process Intensification and PAT for Achieving Real-Time Release
Without such standardization, and appropriate ontologies, it will never be possible for the biopharma industry to realize Pharma 4.0, digital manufacturing, and the level of automation required to ach…
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New Therapies Present Scaling Challenges
New Therapies Present Scaling Challenges
Manufacturing differences between traditional mAb therapies and newer biotherapeutics dictate whether processes should be scaled up, scaled out, or use an al…
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Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
Real-Time Characterization of Biotherapeutics and Comparability of Biosimilars
A major advantage of SPR-based analysis is its ability to estimate the association and dissociation rate constants, an …
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A Plastic Pipeline for Commercial Bioprocessing?
A Plastic Pipeline for Commercial Bioprocessing?
The maturation of single-use technologies presents commercial bioprocessing options for small-volume drug products.
By Rita C. Peters
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FDA Framework Spurs Advanced Therapies
Greater clarity on the application of existing regulations will accelerate development of cell and gene therapies.
By Cynthia A. Challener
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Avoiding Investigational Failures and Discrepancies
For this reason, the International Organization for Standardization (ISO) 9001 revised quality management standard has eliminated the term CAPA from its parlance and has now outlines separate processe…
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Ensuring the Biological Integrity of Raw Materials
By Catherine Shaffer
Contamination with microbes, mycoplasma, viruses, and other adventitious agents can be a significant problem in biopharmaceutical manufacturing. Although contamination can o…
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A Risk-Based Genetic Characterization Strategy for Recombinant CHO Cell Lines Used for Clinical and Commercial Applications
The authors describe the ways in which manufacturers can mitigate the risks related to the integrity of recombinant transgenes expressed in CHO cells.
By Luhong He, Christopher Frye
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Using Single-Use Technologies in Downstream Processing
Trends in Single-Use Systems
BioPharm: What trends are you seeing in the use of SUS in downstream processing for the future?
Mehta: Standardization of designs should allow for greater adoption…