June 2013 Editorial Line-up
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PEER-REVIEWED
Description of a Generic Growth Test Method Aimed at Improving Quality Control of Disposables Used for Industrial Cell Culture
Brian Horvath, Process Technical Development, Late Stage Cell Culture, Genentech; Valerie Liu Tsang, Cell Culture Development, Biogen Idec; Weimin Lin, Cell Culture Development, Biogen Idec; Xiao-Ping Dai, Cell Culture Science, Global Manufacturing and Supply, Bristol-Myers Squibb Company; Kurt Kunas, Amgen, Thousand Oaks, CA; and Greg Frank, Amgen, Thousand Oaks, CA
Disposable bags are widely used in the biotechnology industry. The two main purposes are to store cell culture media and to grow cells for inoculum or production. Several groups have reported growth inhibition resulting from the use of such products. This report shows independent data from four companies, using several different cell lines and growth media, and suggests a method that can be implemented for quality control at disposable bag vendors. |
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• DIA Annual Meeting
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May 8, 2013
Material Close: May 14, 2013 |
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Special Focus: Advances in Protein Analysis |
An Integrated Prefilled Syringe Platform Approach for Vaccine Development
Kingman Ng, Ronald Malone, Changyun Xiong, Xuefeng Yi., Novartis Vaccines and Diagnostics, Inc.
Pharmaceutical product development activities are highly interconnected in nature. For parenteral drug products, the prefilled syringe is generally considered a challenging container closure system, and particularly in the case of vaccines with complex product design requirements. Novartis Vaccines provides a holistic and integrated approach to focus on the linkage of the prefilled syringe with the four phases of product design, development, operation and control.
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Trends in the Use of Plastic in Parenteral Containers
Jennifer Markarian, Pharmaceutical Technology
Interview with Experts from Schott and West on trends and challenges in the use of plastic versus glass vials in parenteral manufacturing.
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Emerging Market Report from Southeast Asia
Jill E. Sackman, a senior consultant at Numerof & Associates, Inc., provides a look at manufacturing within global markets. This month’s article takes a look the Southeast Asia market.
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