Search results for " production" in Articles / App Notes
Article
Implications of Cell Culture Conditions on Protein Glycosylation
The choice of host-cell line for recombinant protein production depends first on the protein’s molecular properties. Certain bacteria can be used for production of the simplest proteins, those that ar…
Article
Fluid Handling in Biopharma Facilities
Facility layout can help determine how companies handle fluid transfer and storage, and increased use of modular facilities and single-use systems (SUS) in the production and transfer of sterile fluid…
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Quality Systems Key to Lifecycle Drug Management
And new policies and procedures at FDA aim to streamline oversight of manufacturing changes for firms that adopt modern production methods able to ensure the continued safety and efficacy of products …
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Essentials in Establishing and Using Design Space
Knowledge of product or process acceptance criterion is crucial in design space.
Design space is generally considered to be the areas where the product or process parameters can be run safe…
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Enhancing Resins Addresses Purification Concerns
…uced quicker than traditional vaccines, confirms Nandu Deorkar, vice-president of R&D, Biopharma Production, Avantor.
The main critical purification challenge for mRNA-based vaccines, howev…
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Flexible Facilities for Viral Vector Manufacturing
While the initial project looked at a monoclonal antibody (mAb) facility, the team plans to extend the concept to cell and gene therapy production.
Cytiva has amassed expertise in modular design a…
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Reliability Rooms and the Move to Proactive Supply Chain Management
Inspiration for this program came from the Toyota Production System principle,
\obeya. Grounded in pure, fundamental data analytics, this concept is roughly translated as “gathering all the info…
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Critical Quality Attributes Challenge Biologics Development
The complex nature of biologics adds additional CQAs that must be determined to ensure the safe development of biologics.
By Susan Haigney
Critical quality attributes (CQAs) are used in biop…
Article
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
By Tom Fletcher, Holden Harris
Regulatory expectations for cell-culture-based biologics production processes changed dramatically once it was discovered in 1996 that a fatal disease (variant Creut…
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Design and Qualification of Single-Use Systems
Much of SUT use occurs in therapeutic protein API production. International Council for Harmonization (ICH) Q7, European Medicines Agency (EMA) Q7, and FDA
Q7A Good Manufacturing Practice Guidance…