Search results for "quality"
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Tools for Continuous Bioprocessing Development
Bioprocess development requires interaction between manufacturer and creator because biopharmaceutical product characteristics and quality are affected by the manufacturing process.
Reliable and st…
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Robust Optimization, Simulation, and Effective Design Space
Establishing a clear line of sight between critical quality attributes (CQAs), process parameters, and material attributes is a primary goal of drug development. Even though there are ICH guidance doc…
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Advanced Technologies Facilitate Scale-up and Technology Transfer
…esents the challenges associated with changing any process, including the risk of affecting product quality in some way. Fortunately, by working closely with tools and technologies suppliers and the …
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Use of Multivariate Data Analysis in Bioprocessing
The increasing use of MVDA has also been fueled by the increasing acceptance of quality by design (QbD) and process analytical technology (PAT) among regulators and the biotech industry. Implementatio…
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Modular Manufacturing Platforms for Biologics
There are numerous benefits related to quality control with building and qualifying units off site. If a full module is unrealistic because of budget or existing architectural constraints, a piecemeal…
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Fermentation for the Future
Drivers of new technology development in microbial fermentation are similar to those for cell-culture processes and include reducing costs, increasing efficiency/productivity, and enhancing quality, s…
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Securing the Single-Use Supply Chain
…the systems and components must be purchased from a supplier, according to John Briggs, director of quality, regulatory, and compliance at ASI-Life Sciences. As a result, adds Mario Philips, vice-pre…
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2014 Manufacturing Trends and Outlook
Survey respondents represented research, development, formulation, and process development functions, as well as quality control/assurance, validation, and laboratory management titles at branded and …
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Biosimilars Development and Supply: How Complex Can the Process Be?
With expanding demand for good-quality healthcare comes the challenge of controlling healthcare expenditures (1). The goals behind the safe and regulated introduction of biosimilars into the market in…
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Optimizing your Cell Culture Process to Improve Productivity
It could also be used to analyze monoclonal antibody protein quality by examining the parameters, supplements, and feed timings, which may help increase the quality of the protein being produced in cu…