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.
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.
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.
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.
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.