Also significant is the increased use of operational excellence programs such as "OpX." When life-science companies examined
automation in the 1970s or early 1980s, their risk-adversion and lack of incentives to optimize manufacturing meant they only
relied on techniques that had already been proven. This has clearly changed. The business is more competitive, customers are
increasingly price-conscious, and manufacturing and supply-chain efficiency is more important. The plant floor and production
are now tied to the way laboratories work, to the timely release of new products, and to overall profitability. Putting the
right kind of automation platform in place can help reach these goals.
Operational excellence also has accelerated companies' top-to-bottom integration. Because FDA now allows more flexibility
in approaches to automation, companies are increasing the integration of their control system and their various enterprise
systems. The OpX program also encourages the change from paper-based compliance systems to electronic records and will continue
to change how life-science companies optimize unit operations, manufacturing, product approval, and product release.
Another big trend is flexibility. The industry is moving from what had been organic-based synthesis and organic-based products
to biologic products. Biologics are more complex, but they're also targeted at smaller groups and even individuals. They require
significantly more flexibility on the part of a manufacturer. Manufacturing-execution systems integrated with process-control
systems will become the platform for flexibility, optimization, and compliance.
Bob Lenich* is life science strategic business director at Emerson Process Management, 12301 Research Blvd., Austin, TX 78759, tel. 512.834.7033,
fax 512.832.3199, firstname.lastname@example.org
Christie Deitz is a senior principal engineer in the Emerson Life Sciences Industry Center.
*To whom all correspondence should be addressed.
Where were you 30 years ago?
Bob: "I had just graduated from high school and was working as a CO-OP at Cabot before going to college at Rose Hulman Institute
of Technology." Christie: "I was a kid enjoying a carefree summer."