5 Lessons Learned on Controlling Fermentation Facility Capital Costs

March 9, 2020 |

By Mark Warner, PE, Founder, Warner Advisors LLC

Special to The Digest

Biotechnology funding is surging and contract fermentation options remain limited, so companies seeking to commercialize advanced biotechnologies are again evaluating options to build required production capacity.  While the “build” approach comes with many benefits, capital costs and requisite funding required to build a commercial-scale fermentation facility spark an inevitable discussion of how best to reduce fermentation facility capital cost.  Having built and operated multiple commercial fermentation facilities, I offer the lessons learned below.

  1. Carpe Diem (seize the day!) – as a steadfast planner, I am fighting brain matter by suggesting over planning can be a negative, but in the case of first-of-a-kind biotechnology facilities, it can.  Carpe Diem is not simply a drive to focus on today, but specifically to give little thought for the future.  Facility design often includes longer term plans for expansion and additional processes included in new facility project scope.  The problem comes from the fact that the proposed process has never been operated at large scale and the actual operation of the process often changes enough to make future plans invalid and a waste of resources.  Very few new biotechnology facilities operate exactly as originally planned.  Quite simply, spending money based on future expansion is not money well spent, when the actual future state is seldom what was initially envisioned.
  2. Capacity versus performance – when making difficult decisions regarding requirements for the proposed facility, there quickly becomes two categories: decisions that drive facility capacity and others that maintain performance.  When money is tight and trade-offs are required, I recommend leaning towards performance over capacity.  This comes from experience that a facility producing less product than planned is problematic, but a facility that cannot produce product of the required specification can be catastrophic
  3. Dr. No – one of the basic concepts of controlling the cost of a new facility is separating musts from wants, which is harder than it appears.  The wants are always good ideas, options that can add flexibility and reliability to a facility.  The problem is that a facility designed for wants commonly costs 30-50% more than a facility designed solely for the primary process.  Steadfast resolution to control costs on projects has given me the nickname “Dr. No” (i.e., no we cannot add that) on multiple projects.  If you have firm capital constraints, a strong commitment to maintaining project scope to must-have items is critical to project success.
  4. Can I use a corn ethanol style fermenter? – I get asked once a month and unfortunately for the vast majority of aseptic aerobic fermentations that are the backbone of advanced biotechnology, the answer is no.  It is unfortunate as ethanol style fermenters have a much lower capital cost, but they are neither aseptic (expected to generate a clean batch), nor aerobic (driven by oxygen), so few processes can utilize them.  The inability to steam sterilize the fermenter is the most common deal-killer.  A detailed technical comparison is summarized in the following table

          5. Downstream recovery, where the wheels come off – much of the focus of early stage biotechnology ventures is on the fermentation portion, where much of the core intellectual property resides.  However, downstream recovery and purification is generally a more expensive and complicated process than fermentation, often representing 65% of the total project cost or more.  This is most common in processes making novel proteins, that typically require multiple purification processes, combined with large scale drying.  Utilizing a fully integrated pilot operation (from feedstock to final product) and understanding the implications of downstream recovery on total capital costs is critical for commercial success.

Constructing a purpose-built facility to commercialize an advanced biotechnology provides the highest level of control, but requires capital that must be managed and minimized.  Focusing on the core process requirements, while pushing back on non-critical items is the proven path to reaching commercial success.

About the Author

Mark Warner is a registered professional engineer with 30 years of experience in process commercialization, focusing for the last 10 years on taking first-of-a-kind-technologies from bench-top to commercial operation.  He is the founder of Warner Advisors and author of “Biotechnology Commercialization Handbook – How to make protein without animals and fuels and chemicals without crude oil”.  He can be reached at [email protected] or visit www.warneradvisorsllc.com.

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