Operations Excellence: BioPharma Operations Excellence

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).

Amir London

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 reasons.

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 their organizations.

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' support.

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.

Survey participants were also asked about which cost elements are taken into consideration when calculating their overall equipment cost of ownership. Responses revealed that many significant cost components such as spare parts, consumables, and cost of failures, are not included by most companies in their overall cost evaluation and comparison.

Industry managers commented during panel discussions that there appears to be a growing acceptance of the valuable role a supplier can play in developing optimized product and service solutions. By following examples in other advanced industries such as the semiconductor industry, suppliers could become essential partners in developing biopharma processes and operational excellence. Wise partnership models would allow manufacturing companies to rely on the expertise suppliers have gained from working with various manufacturing companies and on their vast understanding of regulatory requirements.

For more information related to consortium activity or the biopharma survey, please visit Tefen's website www.tefen.com or e-mail alondon@tefen.com

Amir London is a partner at Tefen Ltd, 1065 East Hillsdale Blvd, #421, Foster City, CA, 650.357.1120, ext. 115, fax: 650.372.1350, alondon@tefen.com