BioPharm International
August 01, 2003
Quality Enhancement
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8
When developing a strategy for using technology in biopharmaceutical manufacturing, include the interaction between automation and business systems and the roles they play in enhancing quality assurance and compliance.
August 01, 2003
Purification and Capitalization
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8
Although gene therapy and DNA vaccination suggest promising new approaches to disease treatment - and nonviral vectors (which are cheap and easy to manufacture) afford low immunogenicity, better safety profiles, and improved stability - commercial-scale purification of plasmid DNA remains difficult, particularly if bovine-derived ribonuclease A is left out of the process. This article series reviews the benefits and limitations of current plasmid DNA purification and suggests an RNase-free downstream process that is scalable, robust, and meets the requirements set by industry regulators.
August 01, 2003
Quality Enhancement
16
8
Process characterization requires a significant commitment of time and resources, but the payoff is better process understanding, improved manufacturing success rates, and avoidance of costly regulatory delays.
August 01, 2003
Purification and Capitalization
16
8
A less-than-favorable venture capital market and a sluggish economy have compelled companies to seek grant money to fund their growth and development activities. Follow these winning strategies for obtaining your next grant.
August 01, 2003
Quality Enhancement
16
8
Good laboratory practice is the central dogma of all laboratory research and investigation - it's your commitment to regulators - and poor laboratory controls are a common cause of 483 observations and preapproval inspection failures.
August 01, 2003
Columns and Departments
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Many companies want to conduct quality assurance activities on the manufacturing floor. But implementation can be held up. Why?
August 01, 2003
Columns and Departments
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8
In Washington, leaders offer assistance and encouragement, speeding new treatments to market.
August 01, 2003
Columns and Departments
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BIO 2003 offered many insights into biopharma's future.
August 01, 2003
Columns and Departments
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8
BioPharm International and Tefen Ltd. have teamed up to provide you with information and tools from the BioPharma Operations Excellence Consortium.