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.
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.