Search results for "quality" in Articles / App Notes
Article
Going Small to Achieve Success on the Commercial Scale
The development of commercial-scale processes that consistently provide high-quality product that meets those specifications requires extensive examination of numerous process variables and potential …
Article
Selecting a Comprehensive Bioburden Reduction Plan
and Vince Anicetti, executive director of quality, Coherus Biosciences. Mittelman and Anicetti are co-chairs of the Parenteral Drug Association task force that developed the bioburden and biofilm tech…
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A Bright Future for the Plasma Fractionation Industry
Among the quality and regulatory trends, Quality-by-Design (QbD) remains to be a popular topic. Philippe Paoloantonnacci presented a QbD approach for a new LFB IVIg product, with identification of Pro…
Article
Optimization of Protein Expression in Escherichia Coli
Here, the authors discuss some parameters that can influence protein yields and quality during protein expression in E. coli.
Bacterial strain selection
The choice of a bacterial strain for prot…
Article
Biotechnology Innovation and Growth in Israel
In recent years, the Ministry of Health has developed strong capabilities in the areas of health technology assessment (HTA), new technology prioritization, and quality monitoring for community-based …
Article
The Lifecycle Change of Process Validation and Analytical Testing
… analytical testing (PAT) technologies to support the monitoring and control of product critical to quality attributes. I think material understanding throughout the manufacturing process from the pr…
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Automated Concentration and Diafiltration of Multiple siRNA Samples
Controlled, systematic, quality small-interfering RNA (siRNA) production is the core of any successful RNA therapeutics program. To effectively screen potential targets for in vivo activity, it is nec…
Article
Sterilization Trends for Single-Use Consumables
…the control of irradiation processes rather than just trusting the supplier-provided certificate of quality claiming sterility for SU consumables. The driver behind this trend stems back to a Form 48…
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Address the complexity of protein characterization
During development and quality control, you may use a range of analytical technologies to characterize biotherapeutic drugs in terms of their structural integrity and activity. This presentation inclu…
Article
Reviewing the Importance of Biosimilarity and Interchangeability
Analytical methods should thus be chosen or developed to compare critical quality attributes (CQAs) between the biosimilar and the reference product. “This involves assessing the physicochemical prope…