The BioPharma Operations Excellence Consortium, facilitated by Tefen Operations Management Consulting, continues to thrive,
recently holding chapter meetings on two separate continents. The US East Coast Chapter met at Centocor's headquarters in
Malvern, PA, while the European Chapter met at Sorono's facility in Vevey, Switzerland. Since its establishment in early 2002,
over 45 leading biopharmaceutical companies have joined the forum, which operates on the basis of using the group's collective
knowledge to drive each member company — and the industry as a whole — to world-class levels of operational effectiveness
EAST COAST CHAPTER MEETING
The theme of the East coast meeting was process excellence, exemplified by detailed case studies of companies utilizing lean
management concepts and tools to drive process improvements. First, Tefen presented an overview of typical lean concepts,
such as Value Stream Mapping, Takt Time, Single Piece Flow, Set-Up Reduction, 5S and Kanban, which are commonly used in a
variety of industries.
Active participation was kicked off with a lean simulation. A "manufacturing" line was set up, and through the simulation,
attendees saw how value-driven-flow and smaller batch sizes can result in better cycle times, lower inventories, and lower
scrap. This sparked an interesting discussion around how these concepts can be applied to biopharmaceuticals, which in many
cases is moving to larger batch sizes due to cost and regulatory drivers.
The group was able to discern what is different about the biotech-manufacturing model as compared to more traditional industries
such as electronics, automotive, and general manufacturing. In our industry there are large economies of scale when companies
move to larger batch sizes. Doubling tank capacity does not necessarily double production time because the release process
takes the same amount of time for small and large batches, and setups and changeovers can be quite lengthy.
The main conclusion from this discussion was that smaller batches may not be cost-effective from a tank size perspective,
but shrinking overall campaigns would be advantageous. If companies can reduce changeover time and eliminate the startup effect
that impacts the quality of new campaigns, there will be a faster response to market needs by producing different products
The Baldridge Award
Two Centocor managers made presentations. Amilcar Toro provided information on the company's overall Process Excellence organizational
structure and strategy. Dan Zajac spoke about Bioreactor Antibody Optimization, providing details on a specific Process Excellence
project that focused on maximizing yields in the fermentation process. He provided a comprehensive look at the methodologies
and statistical tools used to model the fermentors and drive improved performance.
Peter Ryan of Bayer Technology Services concluded the day by discussing Process Analytical Technology (PAT) implementation
paths within biopharmaceutical firms. He presented Bayer's use of tools and concepts and how the resulting data is mined
to improve process quality and simplify the overall quality processes. Tefen's experience supports Bayer's results, indicating
that companies that aggressively adopt PAT find their manufacturing efficiency increases, with a parallel drop in quality
deviations. Consortium members agreed that as FDA and other regulatory agencies continue to proactively promote PAT and the
industry moves forward in adopting process excellence, the use of this technology will become more critical to achieving the