The actual installation of the automation system throughout their bacterial fermentation lab took a single day. Luckily, the installation could be done between experiments, but if experiments had been running, the reactors could have stayed under manual control for that time. At the end of that day, the reactors were up and running again, under the eye of a networked, automated data management and control system.
We want to tell the story of this change because many labs are contemplating automating, but are fearful of disruption. This case history shows that it can be quick, nearly painless, and has huge advantages.
Biopharmaceutical companies struggle to comply with FDA regulations, good laboratory practices (GLP) current good manufacturing practices (cGMP), and process automation technology (PAT) standards during process development, scaleup, and production. Manual methods make this difficult, because changes can't be recorded and tracked, procedures can't be repeated exactly, and systems are less secure. The system security and tracking commonly found in FDA 21 CFR Part 11-compliant manufacturing facilities would be great in process development, but the high cost and inflexibility of the systems usually selected for manufacturing makes them impractical.
The most noticeable benefit of incorporating a comprehensive system is that laboratory scientists are freed from the mundane manual methods of data collection, analysis, and control, and can focus on essential research and development. To make things even easier, having a unified interface for all sources of data means the people in the labs don't have to learn all the different systems. A Senior Process Development Scientist at a large West Coast biotech company pointed out the advantage of this, "Having a common data platform saves time and money in training and in the overhead of integrating different data sources and training on different systems."
As pressure on biopharmaceutical companies to accelerate the commercialization of life-saving biotherapeutics and comply with government regulation increases, incorporating advanced process control and data management is essential. Biopharmaceutical companies are facing major challenges and are; "...compelled to incorporate tools that can improve their productivity and reduce R&D expenditures," according to analyst Raghavendra Chitta of Frost & Sullivan in a July 2005 report.
One senior process development scientist at a large West Coast biotech company made the benefits of automation clear when he said that this automation software, "...gives us profit maximization... We get products to market faster... if we're one month faster to market, that is significant added value —as in more revenue."