Search results for "biologic"
Article
Platform Approach Speeds Process Development
Cell-culture process development
Development of an efficient, robust, and reproducible cell-culture process is key for successful market supply of a biologic drug. Depending on project requirement…
Article
Continuous Processing for the Production of Biopharmaceuticals
…no concrete examples of successful implementation and integration of a fully continuous process for biologic products. The true potential of continuous bioprocessing can only be realized after succes…
Article
Going Small to Achieve Success on the Commercial Scale
Challener
Biopharmaceutical manufacturing involves a series of complex unit operations linked together to provide high-purity, biologic actives with specified physicochemical and pharmacokinetic p…
Article
Tools for Continuous Bioprocessing Development
The FDA ruling stated that the glycosylation of the products manufactured at each scale differed, and, thus, the 2000-liter product required a new biologic license application (1).
Why is process …
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…
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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…
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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. …