Search results for " biologic" in Articles / App Notes
Article
Combining Microbioreactors and Advanced Statistical Techniques to Optimize a Platform Process for a New Host-Cell Line
The ability of PCA to distinguish between the rounds indicated that the method was summarizing biologically relevant behavior.
The loadings of the PCA model were examined to gain insig…
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
Selecting the Right Viral Clearance Technology
Typically, anion exchangers in either a flow-through or bind/elute mode are effective for separating viruses from biologic products,” he remarks.
The importance of early data development
Ideal…
Article
Breakthrough Drugs Raise Development and Production Challenges
Expert review teams in the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) are meeting deadlines and goals for assessing breakthrough designa…
Article
What’s In a Name? For Biosimilars, A Lot
Van Hook, "Role of USP Quality Standards in the Nonproprietary Naming of Biologic Drugs," webinar on Biosimilar Naming & Substitution through FDLI–Food and Drug Law Institute, March 10, 2014, www.fdli…
Article
Quality Systems Key to Lifecycle Drug Management
PACMPs may be appropriate for certain changes to biological products, such as adding a new cell-culture facility, and should be most useful for drugs developed using QbD principles, Robert commented. …
Article
Evaluating Design Margin, Edge of Failure and Process
Design space generation is encouraged in new product development.
Sep 1, 2014
By: Thomas A. Little, PhD
BioPharm International
Volume 27, Issue 9, pp. 46-49
A product’s or proc…
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FDA Urged to Preserve Biosimilar Naming Conventions
“These groups understand that the INN approach to biosimilar naming has proven safe and effective in Europe; it has worked in the United States for chemical drugs and currently approved biologics, the…
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Concentrating Feed—an Applicable Approach to Improve Antibody Production
In this study, the authors evaluated different approaches to prepare highly concentrated feed media for fed-batch Chinese hamster ovary cell culture. By raising the pH or by adding surfactants, the fe…
Article
Q&As with Industry Leaders
… Blackwell, President, Windshire Group, LLC
Regulatory Requirements for Safe and Efficient Biologic Drug Development
Steven Lynn, Executive Vice-President, Pharmaceuticals, Regulatory…