Search results for "quality" in Articles / App Notes

Article Understanding Validation and Technical Transfer, Part 3
It is one part of the overall product control strategy and forms the basis for the critical quality standards (CQAs) that will be approved by regulatory authorities. The product specification is estab…

Article Leveraging Data for Better Biopharmaceutical Process Control
Currently, we are observing a trend toward connecting process condition-monitoring to accurate product quality-control during processing, by very specific techniques such as in-situ mass spectrometry …

Article Bioburden Control in the Biopharmaceutical Industry
…ecies, and Bacteroides fragilis, among others that should not be overlooked in microbiological quality control (2). Moreover, determination and identification of the nature and relative densities of …

Article Reconciling Sensor Communication Gaps
Process analytical technology (PAT), quality by design, and individual company- or process-centric quality initiatives are driving the development of bioprocess sensors and probes. Single-use systems …

Article Biosimilars: Making the Switch Comes with Challenges
There continues to be widespread scepticism in the region about the quality and safety of biosimilars, and sometimes their efficacy, among physicians and patients. This issue is often because of a lac…

Article Biomanufacturing Outsourcing Globalization Continues
Michael Yu, president and CEO of Innovent Biologics (Suzhou, China), a biopharmaceutical company that produces affordable biologics by manufacturing products locally, reportedly, to international qual…

Article Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
… one covering general principles, the second on non-clinical and clinical matters, and the third on quality issues. The deadline for comments on the first two guidelines was the end of October, where…

Article Implementing QbD in Sterile Manufacturing
Critical quality attributes  BioPharm: In implementing a QbD approach, what would you identify as the critical quality attributes (CQAs) in sterile manufacturing and aseptic processing? …

Article Supplier-Change Management for Drug-Product Manufacturers
In some cases, it may take the form of a quality agreement, which is discussed later. An example generic SIC agreement is included in Figure 1. This agreement establishes the need for and timing of re…

Article Using Digital Twins to Model Process Chromatography
[These conditions] may include a changing feedstream quality with respect to product or contaminant concentrations, variations in material quality, such as adsorber capacity and buffer composition, or…

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