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Bay-Tec
Engineering Celebrates Outstanding Project
Genentech’s NIMO
Production Facility wins Project Execution Award
Bay-Tec
Engineering’s “Project Life Cycle Management” approach
helped Genentech Inc. win the Pharmaceutical Engineering
Magazine’s 2007 Facility of the Year Award for Project
Execution for Genentech’s NIMO production facility. By
combining Bay-Tec’s project delivery approach with their
Software Development and Software Quality Programs, the NIMO
production facility was completed on-time and under budget.
The NIMO
production facility was designed to feature very unique
design advancements and technological innovations. By
maintaining a close working relationship throughout the
project, Bay-Tec remained flexible and was able to shift
gears quickly to meet the evolving requirements of the
project. Changing the application code for the plant to
produce Avastin® required entire sections of code to be
deconstructed and rebuilt while adopting the style of
existing code in order to provide seamless integration with
other areas of the plant.
Bay-Tec created
control system and user interface software that will help
streamline production schedule and speed up product
release. Bay-Tec incorporated S88 batch processing in
Fermentation, Media and Buffer Preparation, and Harvest
areas. The system also included real-time and historical
production run tracking integrated into one dynamic system
that was virtually “Error Free” upon delivery to the site.
As an additional benefit from Bay-Tec’s Software Quality
Program; less than 10% of the onsite software start-up
budget was used resulting in a very large savings to
Genentech.
In September 2005,
the NIMO production facility’s first fermentation test batch
of Avastin® produced the largest amount of protein ever
produced in a mammalian cell culture fermenter. Then in
February 2006, seven qualification runs (runs required to
license a plant by the FDA for approval for marketed
production) were completed consecutively while passing all
comparability tests as compared to Avastin® manufactured
at other Genentech sites.
“This project was
anything but ordinary,” stated John Justus, CEO of Bay-Tec
Engineering. “We design and build our control systems to
meet our client’s needs on very tight schedules and within
very strict budgets. That’s our goal for every project we
undertake, and we were delighted that Genentech asked us to
get involved in the NIMO facility. While it was a
challenge, it was the perfect opportunity to show what we
can do on a world stage”.
“Working with
Bay-Tec Engineering has been a great experience for
Genentech,” said Christoph Lebl, Associate Director of
Engineering for Genentech’s NIMO facility. “Bay-Tec’s
performance on this project was a success by every
measurable metric used to gauge the success of a project.
Their ability to quickly assemble a team with qualified
resources and respond to our needs showed us that there are
companies out there that still adhere to the philosophy of
getting a job done right, on-time, and as promised.”
Bay-Tec Engineering
is a control system engineering and construction firm that
has been focused on providing clients with process
manufacturing automation solutions for 25 years.
The company’s
unique organization and tremendously skilled resources
combine to accommodate sophisticated project requirements in
the pharmaceutical, biotechnology, semiconductor,
petrochemical, food and beverage and other process intensive
industries.
The company's
vision is to deliver true design/build project solutions
utilizing in-house design integration and construction
services. This turnkey project execution strategy results
in integrated systems of higher quality with complete
documentation, delivered faster and more economically than a
traditional Design-Bid-Build approach.
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