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BioPharm International-08-01-2003
BioPharm International
Technology Integration: Enhancing QA and Compliance in Biopharmaceutical Manufacturing
August 01, 2003
Quality Enhancement
16
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.
Large-Scale Manufacturing of Plasmid DNA for Gene Therapy and DNA Vaccination -- Part 1: The Suitability of Current Techniques to Purify Plasmid Without Adding RNase
August 01, 2003
Purification and Capitalization
16
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.
A Rational, Step-Wise Approach to Process Characterization
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.
The Grant Story: Why Pursue, Where to Find, and How to Win Research Funding
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.
GLPs and the Importance of Standard Operating Procedures
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.
GMP Issues: Moving QA onto the Manufacturing Floor
August 01, 2003
Columns and Departments
16
8
Many companies want to conduct quality assurance activities on the manufacturing floor. But implementation can be held up. Why?
Inside Washington: Biotechnology is Central to Medical Progress
August 01, 2003
Columns and Departments
16
8
In Washington, leaders offer assistance and encouragement, speeding new treatments to market.
Outsourcing Outlook: Signs of Change
August 01, 2003
Columns and Departments
16
8
BIO 2003 offered many insights into biopharma's future.
Operations Excellence
August 01, 2003
Columns and Departments
16
8
BioPharm International and Tefen Ltd. have teamed up to provide you with information and tools from the BioPharma Operations Excellence Consortium.