Search results for " quality"
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…
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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, wher…
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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?
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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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The Importance of Partnering for Bioanalytical Studies
A quality statement from a quality assurance unit is typically included in the report for any regulated work.
Once the methods are validated, the sample analysis commences that follows bioanaly…
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Recent Advances in the Use of Exoglycosidases to Improve Structural Profiling of N-glycans from Biologic Drugs
Thus, glycan structure is a critical quality attribute (CQA) that must be monitored during drug manufacturing.
Glycan composition profiling is commonly used to track the structural diversity of…
Article
Biopharma Says It Has an Evolution in New Technologies and Processes
Yu, deputy director of the Office of Pharmaceutical Quality in FDA’s Center for Drug Evaluation and Research, talked about the future of pharmaceutical quality—and the challenges of achieving quality …
Article
Reliability Rooms and the Move to Proactive Supply Chain Management
Manufacturers must not only speed product delivery but ensure quality, safety, and efficacy. Success demands consistent discipline and rigor from supply chain and manufacturing operations, as well as …