SECTION TITLE CMO


How does one calculate existing and underutilized capacity, when users order and rapidly install single-use systems and even whole facilities on an as-needed basis? Single- use equipment is simply meant to be used and then trashed. Is an empty room/suite that has been used or has been set aside for installation of single-use bioprocessing systems to be considered under-utilized capacity, or only underutilized when fully-ready for use but sitting idle? Will availability of operations staff become a measure of capacity?


Will capacity utilization even be a concern in the future as single-use systems and modular systems improve and are increasingly used for commercial-scale manufacture?


A number of companies, such as G-Con and GE, are starting to introduce fully modular, e.g., connectable trailer- or shipping container- based, bioprocessing systems, taking the current trend for increased single-use plug- and-play to a new extreme. For example, Pfizer joined with GE for rapid construction of a large modular manufacturing facility for biosimilars manufacture in China. Modular facilities will further confound estimation and interpretation of company and industry capacity and utilization. How does one calculate capacity utilization when whole integrated single- use-based modular factories can be custom ordered and delivered anywhere in the world within a matter of months?


CMOs, including CMC in Copenhagen, and FujiFilm Diosynth in North Carolina, are using multiple 2000L bioreactors run in parallel, to create single batches that meet the demands of many, even blockbuster biologics. This is especially true as productivity out of the bioreactors increase, and titers increase; in some cases titers have doubled over the past 10 years. This means bioreactors can be substantially smaller for the required production.


Impact of Technology on Capacity


Capacity and productivity are some of the most important trends this year, in our 13th Annual Report and Survey of Biopharmaceutical Manufacturing Capacity and Production.1 And our data show that neither CMOs nor biotherapeutic developers predict any “significant” or “severe” capacity constraints over the next 5 years.


In fact, fewer than 1 in 4 bioprocessing professionals surveyed this year report that they believe their facility will experience either “significant” or “severe” capacity constraints over the next 5 years, by 2021. This is about the same as last year.


Source: 13th Annual Report and Survey of Biopharmaceutical Manufacturing, April 2016, www.bioplanassociates.com/13th


Figure 3. Factors Creating Future, 5-Year Capacity Constraints; Biotherapeutic Developers vs. CMOs (Select Data)


Source: 13th Annual Report and Survey of Biopharmaceutical Manufacturing, April 2016, www.bioplanassociates.com/13th


Figure 4. Key Areas to Address to Avoid Capacity Constraints; Biotherapeutic Developers vs. CMOs (Select Data)


CMOs overall express more capacity constraint concerns than product developers. This could simply be that CMOs are getting more fully booked-up with projects. Also, to unknown extents, future capacity constraints may be foreseen due to companies now expanding their R&D, companies’ product pipelines seeing success and progressing to larger-scale, and/ or respondents presuming that some current equipment and facilities will be obsolete 5 years from now.


pharmoutsourcing.com | 29 | November/December 2016


What’s Causing Constraints – And How Can CMOs Avoid Them?


As part of our analysis of capacity constraints, we asked CMOs to evaluate the factors likely to create production capacity constraints at their facility over the next five years. We found that 70% of CMOs expect to outgrow their facility in five years, compared with


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