Search results for "quality" in Articles / App Notes
Article
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…
Article
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 …
Article
Evaluating Surface Cleanliness Using a Risk-Based Approach
… to reduce testing during cleaning qualification and continuous monitoring stages without impacting quality. Laboratory results from total organic carbon (TOC) and conductivity rinse sample for an al…
Article
Perfusion in the 21st Century
Now, improved continuous culture technologies such as perfusion are on the rise, as biosimilar manufacturers look for new ways to cut costs while increasing quality and productivity.
With perfusio…
Article
Framing Biopharma Success in 2016
Encouraging companies to make capital improvements to avoid future quality and manufacturing problems, however, can be a tough financial and regulatory argument. In a 2015 survey of 100 executives fro…
Article
Implications of Cell Culture Conditions on Protein Glycosylation
Richard Easton
This article reviews the implications of cell-culture conditions on biologic product quality, focusing on glycosylation and analytical techniques for its accurate assessment. Glyco…
Article
Tackling Analytical Method Development for ADCs
Both small and large
As for any drug, analytical methods for the characterization of ADCs must be developed, and separate quality control (QC) tests must be established for lot release of the fina…
Article
Improving PAT for Biologics
Dec 01, 2014
By Cynthia Challener, PhD
BioPharm International
A key component of the quality-by-design (QbD) approach to pharmaceutical manufacturing is the implementation of process ana…