Three meetings of the BioPharma Operations Excellence Consortium, facilitated by Tefen Operations Management Consulting, were
held recently. The east coast meeting was hosted by Genzyme at its headquarters in Cambridge, MA; the west coast Chapter met
at the Genentech campus in South San Francisco, CA; and the European forum held its meeting in Frankfurt, hosted by Aventis.
A major focus at all three meetings was to discuss the current adoption level of Process Analytical Technology (PAT) and advanced
software solutions in the industry, as well as the expected impact of such technologies on future advancements in operations
In general, a recent industry-wide survey conducted by Tefen and Millipore Corporation indicated that more than 50 percent
of the 100 industry-leading organizations who responded either have a PAT program in place or are planning to initiate such
a program during 2005. The survey also revealed the three most valuable PAT features industry professionals seek to initiate
are: real-time product release based on in-process testing, improved characterization of process variation leading to reduced
regulatory scrutiny, and improved product quality assurance through proactive design for manufacturing. When surveying the
expected time frame for such functionalities, about one-half answered they expect those solutions to be common in the industry
in only four to ten years, while twenty to thirty percent estimated a much quicker adoption of one to three years.
A key speaker at Genzyme's session, Glen Williams, general manager of Biogen-Idec's facility in the Research Triangle Park,
NC, presented a session on process data management using a system that collects data from a variety of sources such as LIMS,
DCS, document management, and manual entry. The system supports statistical process control (SPC) analysis, process monitoring,
and raw materials evaluation. Combined with the use of a multivariate analysis tool, the facility is able to identify and
highlight key causes of variation from batch to batch and works to eliminate them. The system implementation is a key step
to adopting PAT at Biogen-Idec.
Genzyme's Manoj Menon, process engineering manager, provided a presentation on the use of process data statistical analysis
for efficient scheduling of manufacturing operations. Through detailed data capture of production information in the filling
area on average filling yields and lyophilizer load sizes, optimal campaign sizes were determined for various formulations
to minimize lost lyophilizer capacity and scrapped product. Menon explained that without the ability to collect and present
valuable data, this project would have been impossible to complete.
Lisa Miller, director of manufacturing, and Regina Grochowski, senior manager of compliance, Human Genome Sciences (HGS),
offered a presentation at the west coast meeting summarizing HGS' implementation of a variety of advanced IT solutions. From
CAPA to ERP, HGS put a number of critical systems in place. This effort required significant, dedicated IT and implementation
resources, but because the company views technology as a priority, it was able to meet its ramp- up targets.
Peter Bland, senior manager at Global Change Control at Genentech, presented a company project that transitioned an object-oriented
document model for batch records. Based on a company assessment, one of the causes for a slow new product introduction process
was the difficulty in creating documents — people were spending a significant amount of time creating new documents from scratch,
while numerous versions of documents for similar processes already existed, resulting in confusion on the part of the operators
using the documentation. Through a Six-Sigma project, Genentech identified a potential 50 percent reduction in labor time
invested in document creation by designing standard templates, or objects, that are reused to create process documentation.
A key project requirement was that the developed object model could integrate nicely with a future manufacturing execution
system (MES) solution, currently in the planning stages at Genentech.