The Process Science group at a Northern California biopharmaceutical company recently changed its methods of data management
and process control from manual to automated. The company's Lab Director said that, thanks to the automation now in place,
"We have realized a 30% savings in time, resulting in substantial development cost reductions."
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.
The staff attended two days of training on-site, one day geared to researchers and the other to technicians. Over time, various
customizations and new instruments were added, nearly all without shutting down the system or interrupting running experiments.
The bacterial fermentation lab did not need to have any of its instrumentation replaced in order to install the new automated
system. All the existing instruments were brought together under one unified interface. All sources of data were managed together,
all available for display, calculations, and control. New instruments were added later, and they were integrated with the
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.
However, a good software solution enables FDA-compliant systems for labs and pilot plants, with full security and tracking
features, without sacrificing the flexibility and openness required during process development. The tracking is transparent
to users of the system, and the security can be configured by each facility to be as free or as rigorous as required. When
new instrumentation is purchased, it can be integrated into the same interface as illustrated in Figure 1.
Figure 1. Automated process control and data management allows easy expansion.
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."