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Issue link: https://lifescienceleadermag.epubxp.com/i/183480
BIO INNOVATION NOTES For example, CMC Biologics recently purchased the XOMA Corp. facility in Berkeley, CA so that it could meet specific, emerging technical and equipment needs. According to Andy Walker, Ph.D., CMC's VP of process development, "We listened to our customers and determined that our acquisition of the former XOMA manufacturing facility will enable CMC to support some types of manufacturing processes which were not as easily supported at our facilities in Seattle and Copenhagen. In addition, being closer to some of our clients ensures we are providing the flexibility required for the relationship." CMOs HAVE THEIR COMPLAINTS, TOO Of course, it's not just the client that has issues when establishing or maintaining a relationship. We separately surveyed a sample of CMOs to see what they deemed to be the most common mistakes made by their biopharmaceutical clients. The most commonly cited problem? Clients not communicating with them effectively. This was identified as a "very common problem" or "somewhat common problem" by every single CMO. Following that, a long list of the issues frequently mentioned by respondents included: • • • "Clients don't build in sufficient time for the project (unrealistic timeframes)" "Clients want to contain cost by doing limited development runs but still expect successful full scale manufacturing" "Clients expect us to resolve the most difficult scientific or technical problems." COMMUNICATION IS KEY It's telling that two of the five most common issues cited by CMOs also relate to communication and scheduling. These appear to be real pain points on both sides of the coin — with the ability to screw up an otherwise solid relationship. Indeed, as the biomanufacturing contract manufacturing industry continues to mature, issues revolving around customer service and solid client-vendor relationships could become even more important, especially if CMOs find it difficult to differentiate themselves on the basis of non-negotiable issues such as quality compliance and IP protection. Ultimately, entering into a partnership requires trust and making a leap-in-faith that both parties will do things right and on schedule. Figure 1: Selected Outsourcing Issues Critical Issues When Considering Outsourcing Biopharmaceutical Manufacturing To A CMO, 2013 Offer a secure supply (control of capacity) 38.6% 52.6% Stick to a schedule Demonstrate a track record with products similar to mine Establish a good working relationship 38.6% 49.1% 56.1% 38.6% Percent responding important Percent responding very important 50.9% 40.4% Figure 2: Most Common Mistakes Biopharmaceutical Sponsors Make With Their CMOs "Very Common Problem" or "Somewhat Common Problem" Clients don't communicate with us effectively 100% Clients don't build in sufficient time for the project (unrealistic timeframes) 91.7% Clients want to contain cost by doing limited development runs but still expect successful full scale manufacturing 91.7% Survey Methodology: The 2013 Tenth Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production yields a composite view and trend analysis from over 300 responsible individuals at biopharmaceutical manufacturers and CMOs in 29 countries. The survey included over 150 direct suppliers of materials, services, and equipment to this industry. This year's study covers such issues as: new product needs, facility budget changes, current capacity, future capacity constraints, expansions, use of disposables, budgets in disposables, trends in downstream purification, quality management and control, hiring issues, and employment. The quantitative trend analysis provides details and comparisons of production by biotherapeutic developers and CMOs. It also evaluates trends over time and assesses differences in the world's major markets in the U.S. and Europe. If you want to learn more about the report, please go to bioplanassociates.com. 8 The CMO Leadership Awards 2013