Search results for "quality" in Articles / App Notes
Article
What’s In a Name? For Biosimilars, A Lot
…sion is to improve global health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. Our flagship compendia of public standards—Uni…
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Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
The present case study shows that film-manufacturing parameters can be controlled to manufacture, from a cell-culture perspective, high-quality and low-quality films.
Materials and Methods
Res…
Article
Technologies and Practices Must Evolve to Meet Demand
The respondents reported that they were involved in many phases of drug development and manufacturing including process development, drug-substance and finished product manufacturing, quality control,…
Article
What Drove Biopharma Development in 2014?
One of them is Quality-by Design (QbD). As federal agencies continue to push for proof of quality in biologics, there is increased interest in, and use of, QbD in pharmaceutical development and that t…
Article
New Era for Generic Drugs
Henry Waxman (D-Calif), who is retiring from Congress but continues to urge vigilance to ensure that Americans retain access to low-cost quality medicines.
A September conference commemorating Hatc…
Article
Design of Experiments for Analytical Method Development and Validation
Design of experiments (DOE) is a well-proven characterization approach within product and process development and a key aspect of quality by design. Recently, more attention has been placed on applyin…
Article
Early Communication with Regulators is Essential for SMEs
“Quality documentation continues to be a problem area for many SMEs, particularly relating to manufacturing process validation, the setting of specifications, and stability data,” says the SME Office …
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Essentials in Establishing and Using Design Space
Design space is generally considered to be the areas where the product or process parameters can be run safely (without failure or high amounts of degradation) and achieve all critical quality attribu…
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Evaluating the Use of Continuous Chromatography
As the biopharmaceutical industry strives to demonstrate, continuous manufacturing offers the benefits of higher productivity and better product quality than traditional batch manufacturing. In additi…
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Maximum Output Starts with Optimized Upstream Processing
“The latest iteration of technologies is being developed with scalability, process intensification, and lean principles in mind to ensure quality and reliability for the life of a process,” he asserts…