Understand Development and Manufacturing Mindsets In developing a biotechnology product, one of the most difficult questions to answer is when to allocate resources for process development. Rapid process development can provide a key strategic advantage. Yet no one wants to allocate resources to a product that is not efficacious. Therefore, walking the fine line between too much too soon and too little too late is a fine balancing act. Another issue that makes development difficult is the mindsets that occur in research, development and manufacturing. In some companies an outsider gets the impression these various groups have very different goals. In practice, the education and experience of these groups lead them to approach the same issues from divergent positions. When left to themselves these differences work against the success of the organization. However, there are ways to manage these differences. The first step is to recognize them. The following table, from Wheelwright (1994), outlines some of the key differences in the manner of thinking between personnel in manufacturing operations and in R&D. Unless understood and treated, these differences may form insurmountable barriers to communication within the organization.   Manufacturing R&D Goal Seek product, even if underlying principles are not understood Seek to understand principles, even if product goal is unmet Means to achieve goal Our methods are better Don't monkey with our invention Project worth Pursue only projects with high profitability Pursue novel (and publishable) ideas Planning Plan and budget for given time; accept outcome Plan for outcome; accept whatever time is required Capital versus labor implementation Labor is expensive, so replace it with capital Capital is unavailable, so use more labor Technical requirements They don't understand our situation They're not real scientists Endpoint definition Transfer is not complete until values of all parameters are known Transfer is complete when the process has been run once Possibility of success The process is underdeveloped and needs too many resources They don't have the technical ability to handle our process Wheelwright, S.M., "Commercializing Biotech Products," Bio/Technology 12:877:880 (1994). Let SMW help you Strategic Manufacturing Worldwide has particular expertise in developing manufacturing processes for biotech products and can help you address these technical issues. process optimization for minimum cost and maximum yield process throughput for maximum output fermentation, cell culture and downstream process design scaleup from development through production Contact SMW at info@smwbiotech.com. Copyright © 2004 Strategic Manufacturing Worldwide