CMO


58.5% of biotherapeutic developers. Other critical capacity problems involve hiring and retaining staff. And this brings us back to the issue of measuring capacity utilization - will human factors like staff-hiring backlogs become a more accurate measure of capacity constraint?


Avoiding Capacity Problems


Figuring out how to avoid these problems today, however, seem to center more around innovative equipment, than hiring better. For example, 58.8% of CMOs reported that to avoid capacity constraints in future production, key areas that need to be addressed includes developing more cost-effective disposable, single-use products. Other important key areas CMOs believe should be addressed included better- performing disposable, single-use products and better continuous bioprocessing-downstream technologies (both tied at 52.9%)


CMOs tend to be somewhat more forward thinking in terms of addressing capacity issues. They are, for example, also more likely to seek the development of better performing and more cost-effective downstream purification technologies, in order to avoid future constraints.


Conclusion


Capacity utilization and overall capacity in bioprocessing are rapidly becoming questionable measures of a facility’s ability to avoid capacity constraints. Technology adoption, and improved manufacturing pro- ductivity are taking a more critical role as facilities invest in strategically avoiding creating capacity crunches, or leaving expensive capacity under-utilized. In the future these manufacturers are improving their ability to meet demand for more production by rapidly deployed single-use technologies and planning using modular facilities. Further, production processes are being constantly developed to increase productivity and yield. Still not fixed, yet, are the more human factors like availability of trained, proficient scientific and operations staff.


And if the drive towards more targeted therapies with smaller populations continues, biomanufacturers will need to produce a larger number of


Survey Methodology: The 2016 Thirteenth Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production yields a composite view and trend analysis from 222 responsible individuals at biopharmaceutical manufacturers and contract manufacturing organizations (CMOs) in 27 countries. The methodology also 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, trends and 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.


Pharmaceutical Outsourcing | 30 | November/December 2016


products in the same facilities, with many more changeovers. Efficiency is contingent on enabling technologies, like single-use systems, but also on improving human operations (such as staggered changeover times) in which bioprocessors have limited experience. Further, technological improvements, such as for complex continuous bioprocessing will also require an entirely new set of experienced operators. All of which could add to the capacity constraint equation in the future.


References


1. 13th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production, BioPlan Associates, Inc. Rockville, MD., April 2016,


Eric S. Langer is president and managing partner at BioPlan Associates, Inc., a biotechnology and life sciences marketing research and publishing firm established in Rockville, MD in 1989. He is editor of numerous studies, including “Biopharmaceutical Technology in China,” “Advances in Large-scale Biopharmaceutical Manufacturing”, and many other industry reports. elanger@ bioplanassociates.com 301-921-5979. www.bioplanassociates.com


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