Search results for " containers" in Articles / App Notes
Article
Implementation of Raw Material Control Strategies in the Manufacture of Single-Use Bioprocessing Containers
Disposable bioprocessing containers, such as those used for fluid storage or as bioreactor bags, are usually made from multilayer films. Typical resins used in multilayer films include, but are not li…
Article
Automated harvesting and 2-step purification of unclarified mammalian cell-culture broths containing antibodies
Therapeutic monoclonal antibodies represent one of the fastest growing segments in the pharmaceutical market. The growth of the segment has necessitated development of new efficient and cost saving …
Article
Aseptic Processing: Keeping it Safe
Single-use containers for aseptic processing—such as filters, tubing, connectors, and bags to hold bulk products—are already relatively common in aseptic filling, and can also help keep contamination …
Article
CoAs Help Secure the Supply Chain
Some latitude is given for drug product containers and closures. Some of the tests that need to be performed to verify the results on the CoA for containers and closures may not be practical for the p…
Article
Quality by Design and Extractable and Leachable Testing
Satisfying all of these functional requirements includes testing of a spectrum of components and materials: plastic containers, metal springs, elastomeric valves and gaskets, adhesives, and coatings. …
Article
Safety Drives Innovation in Animal-Component-Free Cell-Culture Media Technology
Advances in cell culture media technology have helped achieve safer biologics.
By Tom Fletcher, Holden Harris
Regulatory expectations for cell-culture-based biologics production processes ch…
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An Integrated Approach to Ensure the Viral Safety of Biotherapeutics
Testing product and process intermediates alone is helpful, but does not provide a complete solution to viral safety. This article proposes integrated solutions for systemic and proactive viral risk m…
Article
Modular Manufacturing Platforms for Biologics
May 01, 2015
By Randi Hernandez
BioPharm International
Volume 28, Issue 5
It should come as no surprise that the good design principles governing the execution of pharmaceutical manu…
Article
Addressing the Challenges in Downstream Processing Today and Tomorrow
Newer classes of biotherapies will require innovations in processing technology.
By Glen R. Bolton, Bernard N. Violand, Richard S. Wright, Shujun Sun, Khurram M. Sunasara, Kathleen Watson, Johna…
Article
Generating a Fully Processed Antibody
The authors outline cell-line development and process scale-up for an antibody program in which the antibody requires additional processing by a site-specific enzyme for correct functionality.
B…