September/October 2006
Volume 26, Number 5

 

Articles

Biotech CIP Cycle Development: Case Study Examples Utilizing QRM
by Matt Wiencek
This article presents case study examples of CIP cycle development activities and lessons learned from several modern biotechnology facilities. The CIP Cycle Development program incorporates aspects of Quality Risk Management (QRM) to meet the needs of the biotechnology industry in today’s regulatory environment.
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The Role of Process Simulation in a Renovated Biologics Facility – A Case Study
by Daniel Lavin, Himabindu Gopisetti, Peter N. Notwick
This article describes the application of standard process simulation techniques to predict the performance of an existing biologics plant after recent upgrades of the facility. The work confirmed the viability of the proposed design, but with qualifications.
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Robotic Processing in Barrier–Isolator Environments: A Life Cycle Cost Approach
by R.L. Dutton, J.S. Fox
This case study presents a Life Cycle Cost (LCC) analysis applied to an example of a roller bottle cell culture process that suggests how the process can be further optimized through a change in the process protocol.
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Interview with Phillip L. Gomez, PhD, MBA, Director of Vaccine Production, Dale and Betty Bumpers Vaccine Research Center, National Institute of Allergy and Infectious Diseases
Dr. Gomez discusses the goal of the Vaccine Research Center (VRC), significant changes in the development of vaccines to improve global human health, and possible new technologies that could challenge the drug manufacturing industry.
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Comparison of Campaign vs. Concurrent Large-Scale Cell Culture Facilities
by David Estap, Frank Wilde
This article compares a campaign with a concurrent large-scale cell culture manufacturing facility; including advantages, disadvantages, investment cost, and production capacity.
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Wireless Framework for Enterprise Excellence: Managing, Securing, and Validating
by Janice Abel, Hesh Kagan, Ian McPherson
This article describes management strategies to overcome uncertainty, cost, and regulatory vulnerability in wireless implementations.
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Process Solids Handling Approach for Multi-Product Bulk API Facility
by Prashant Desai, Pramod Biyani
This article presents a case study describing the approach taken for handling process solids for a multi-product bulk API Manufacturing Facility.
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Using Cycle Time Analysis to Enhance Operations and Improve Yield
by Robert F. Dream
This article analyzes the necessity of a pharmaceutical expansion project or new plant by attempting to understand the business and the production capability of the firm.
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Tumor-Targeted Immuno-Liposomes for Delivery of Therapeutics and Diagnostics
by Tamer A. Elbayoumi, Vladimir P. Torchilin
This article presents the findings of a report that demonstrates the potential for immuno-liposomes as tumor-targeted vehicles.
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Departments

New Products and Literature

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ISPE Update

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Classified Advertising

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