From Concept to Commercial Operation


Contract Fermentation Landscape by Mark Warner

With funding ramping up, many advanced biotechnology start-up ventures are looking to utilize contract fermentation facilities for scale-up support. This paper discusses the challenges and considerations of this approach. Click here to learn more.

Biotechnology Scale-Up Hacks by Mark Warner

Not enough time or money to scale-up following the traditional rules of advanced biotechnology (10:1 scale-up factor, 1,000 hours of integrated pilot/demo operation, etc.)?  Welcome to the reality of the biotechnology start-up world.  Learn some risk-based approaches to streamlining scale-up efforts here.

Lessons Learned Presenting Biotechnology Scale-up during Fundraising by Mark Warner

This white paper provides a lessons-learned based perspective on presenting scale-up plans during fundraising efforts and is based on participation in raising over $1B of funding for advanced biotechnology ventures.
Lessons Learned Presenting Biotechnology Scale-up during Fundraising

Advanced Downstream Recovery – Converting Fermentation Broth into Products by Mark Warner

This white paper outlines perspective on scale-up of downstream recovery in fermentation based processes. Click here to learn more.

Advanced Fermentation Must-Knows by Mark Warner

Enjoyed the opportunity to present advanced fermentation scale up with Jeff Lievense ( at Genomatica. A must see for anyone commercializing advanced biotechnology. Slide deck to my presentation is below along with a link of the complete webinar that was hosted by Biofuels Digest.
Link to the webinar: Click Here
Biofuels Digest Webinar

Scaling-up through Contract Manufacturing by Mark Warner

This white paper provides a lessons-learned based perspective on scaling-up advanced biotechnology through contract manufacturing operations (CMOs), including benefits and common pitfalls of using CMOs.
Scaling-up through Contract Manufacturing

Strategic Approach to Scale-up by Mark Warner

This white paper provides a lessons-learned based perspective on scale-up of advanced biotechnology, specifically focusing on how to look at process development strategically and focus on unit operations that match the economic reality of the target products.

biofuel engineer Strategic Approach To Scale-Up

Take the Test – Evaluating Commercial Readiness by Mark Warner

This white paper provides a framework and assessment tool to allow ventures to assess their current state of process development and whether they are ready to make the next step on the commercialization path from a technology standpoint.

biofuel engineer Take the Test Evaluating Commercial Readiness

biofuel engineer DMG Scorecard Example

biofuel engineer Scorecard

Commercializing Innovative Foods by Mark Warner

Understanding the challenge of commercializing innovative foods will separate those that change the future of food, from others that become an asterisk in a market study. The following white paper provides a self assessment for ventures looking to commercialize a novel food technology and outlines many of the key considerations to ensure success.

biofuel engineerCommercializing Innovative Foods White Paper

What Makes Scale-up Of Industrial Biotechnology So Difficult? by Mark Warner

Two questions have dominated the responses received after my Lessons Learned series on commercializing industrial biotechnology and the deep-dive into the industrial biotechnology commercialization process, the questions are what makes scale-up of industrial biotechnology so difficult and of course how can risk be reduced in the process? Looking back at the materials, there are a few areas that need to be expanded in greater detail to answer those questions, as follow:

biofuel engineerScale-up White Paper

Understanding Advanced Biotechnology Commercialization by Mark Warner

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. 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 the journey. This is a four part series with links as follows:

Top 10 Lessons Learned Commercializing Advanced Biotechnologies by Mark Warner

Spending half a billion dollars placing steel in the ground to commercialize advanced biotechnologies for fuels, chemicals and food applications, is the easy part. Doing it successfully is the hard part – but I have been fortunate to lead many successful projects over the last ten years, and that is what has prompted me to share my personal experience in this three-part series of Top Ten Lessons Learned. I have done my best to include real world examples and attributes that make ventures succeed, as well as common pitfalls. My focus is on the technical perspectives of technology deployment, from early stage process development, engineering, and construction to a fully operational commercial facility. This series is for anyone who is passionate about scaling advanced biotechnology dreams.

biofuel engineer Part 1 – Development and Scale-up

biofuel engineer Part 2 – Process Design and Deployment

biofuel engineer Part 3 – Financing, Start-up and Operations

Mark Warner, P.E.

Mark Warner, P.E.


7909 Walerga Rd., PMB 241
Sacramento, CA 95843

(425) 260-4203


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