Understanding Advanced Biotechnology Commercialization, Pt 1

September 29, 2015 |

Mark Warner HeadshotPart 1 – Overview and Project Development

By Mark Warner, PE, Founder, Warner Advisors LLC, Special to The Digest

When I reflect on the characteristics of successful advanced biotechnology companies that have achieved commercial scale, and the longer list of companies that haven’t, the difference between success and failure is often not the core technology alone, rather the lack of knowledge and execution of navigating through the commercialization process.   Specifically, the navigation from process concept and engineering stages, through construction and startup, to the pinnacle goal of a reliable and profitable manufacturing operation.  Reaching that reliable manufacturing operation is the goal our industry cannot lose sight of, to succeed as an advanced biotechnology community, we need more technologies to reach commercial scale and endure long-term manufacturing operations.

In an effort to better educate the advanced biotech community on the reality of commercialization, I have developed a video series that is a “deep dive” into the entire commercialization process, from concept to commercial operation for a first-of-a-kind commercial scale biotechnology, as illustrated below:


This series is intended for anyone who is working to take a new technology from the bench/pilot stage to commercial operation.  This includes engineers, scientists, management and investors, anyone who will benefit from a detailed understanding of the process before they begin.  Think of this way, if you are heading out on an 8-mile hike, wouldn’t it be good to know if there is a bridge washed out at the 6-mile mark?  The same can be true of commercialization.   You do not want to spend significant resources to prepare a bank finance or federal loan guarantee application, to find out your technical package is insufficient.  In addition, I will provide answers to frequently asked questions:

  • • What is FEL and why do I need to do it?
  • • I have a capital cost estimate for my project, how do I know if I can rely on it?
  • • The project execution timeline looks pretty linear, what can I do to compress the schedule and still be successful?
  • • I have been told I need an EPC contractor, what does that mean?

The series begins with an Overview that can be found here:

And the Project Development portion of the series which is here:

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 has worked for four companies who have held the #1 spot in biofuels digest’s top company list, in a range of advanced biotechnologies including biodiesel, cellulosic ethanol, phototrophic algae, heterotrophic algae and innovative food products.  He is the founder of Warner Advisors, providing consulting services and acting in interim engineering leadership roles for advanced bioeconomy clients.  He can be reached at [email protected] or visit www.warneradvisorsllc.com.

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Category: Thought Leadership

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