Formal process and operation improvement activities are being employed in almost every biopharmaceutical manufacturing company,
according to a recent survey conducted by Tefen Ltd and Millipore Corporation. The industry-wide survey was conducted to assess
current biopharmaceutical operations excellence (OpEx) trends and needs, as well as OpEx perceptions and expectations related
to industry suppliers. Highlights of the study were presented by Amanda Turton, Millipore BioProcess Division's director of
market research and communications, at three recent quarterly meetings of the BioPharma Operations Excellence Consortium,
facilitated by Tefen and hosted by Wyeth BioPharma, Grange Castle, Ireland (European chapter of the consortium); Abbott Bioresearch
Center, Worcester, MA (east coast chapter); and Cell Genesys, South San Francisco, CA (west coast chapter).
The study was conducted between December 2004 and January 2005 and included over 75 senior managers, directors, and vice presidents
working primarily in the manufacturing, process development, and quality operations departments of large biopharma companies.
More than 50 percent of companies surveyed employ more than 2000 workers.
According to the survey, the two most commonly employed improvement programs are lean operations and Six Sigma (or a combination
of the two), and the key operational performance indicators (KPIs) most frequently measured are cycle time (91 percent of
surveyed companies are using the measure), deviations (91 percent) and cost (77 percent). Figure 1 illustrates a complete
analysis of KPI used by the industry. As for manufacturing improvement, while 64 percent of the firms are engaged in "right
first time" and "error proofing" activities, there is a wide variety of other initiatives involving capacity and productivity
increase, cost reduction, and reliability improvement.
Figure 1. Performance Measurement
The survey also demonstrates that quality operations improvement programs focus on four main types of activities: deviations
reduction, documentation simplification, change control improvement, and quality control (QC) testing cycle-time reduction.
The primary focus of supply chain management programs is supplier qualification and certification. Key process development
improvement programs, in which 40 to 50 percent of respondent companies are involved, include understanding process variations
using integrated project management practices and comparability protocols to facilitate technology transfer.
Respondents commented that the most critical factor impacting their inability to achieve OpEx objectives is insufficient time
or resources, while the second key obstacle is internal resistance to change mainly stemming from conservative attitudes.
When asked about their incentives to adopt new technologies, equipment, and consumables, respondents listed greater reliability
(more robust, error-proofed processes) and increased capacity utilization (higher yields, titers, and recovery) as the top
The survey also covered industry readiness related to process analytical technology (PAT). The study indicates that 70 percent
of companies in the market have become aware of PAT within the last 12 to 24 months, but fewer than 40 percent already have
a related program. Approximately 45 percent of respondents are not aware of any formal plans to implement PAT programs in
The top three criteria mentioned by industry representatives for supplier selection are: positive past experience with a specific
supplier, proven high technological capabilities, and good service levels. The prevalent perception is that the role of suppliers
is to provide not only the required equipment and technology, but also a variety of tactical and value-added services — such
as performance limits data, training programs, validation protocols and on-site support, software interfaces development,
and preventive maintenance protocols and plans — to support their product offerings. Strategic activities related to quality
and compliance strategy development, development of risk management processes, and process design to manufacturability are
still considered as activities to be performed internally by the manufacturing companies with little to no use of suppliers'
Some survey participants critiqued suppliers, saying they should provide more product-specific data and not just general information,
and although the situation is difficult and often confidential, suppliers need to be more knowledgeable about how their products
are used by their customers and about their customers' processes.