Synthetic Biology Commercialization

Synthetic Biology is a term that represents accelerating technologies that use modular tools across a wide range of disciplines as illustrated in the figure to the right. It focuses on designing, redesigning and building organisms or parts of organisms. It can be thought of as a biology-based “toolkit” that uses abstraction, standardization, and automated construction such as Crispr-Cas9 to define how we build biological systems. In terms of its contribution to society, synthetic biology can provide solutions to the challenges we are facing in our chemicals, consumer products, fuels, polymeric materials, agriculture, human health, animal health, flavors and fragrances, nutritional supplements, food ingredients, cosmetic additives, and our growing food requirements.

As an example of a specifically focused area: Synthetic biology can improve the efficiency and sustainability of food production by identifying improved and efficient ways of producing nutritional supplements, such as proteins, fragrances or flavoring agents, or increasing the efficiency of existing production systems. New techniques could also be developed to improve the production, shelf life and quality of food products while reducing the risk of using harmful chemicals.

Synthetic Biology is accelerating the development of products at bench scale. The challenge ahead is the scale-up, demonstration, and commercialization of products and this challenge can be addressed by the engagement of Lee Enterprises’ subject matter experts.

Lee Enterprises Consulting’s breadth brings focused, interdisciplinary solutions to support projects such as:

  • Guiding you with experienced planning from bench, to scale up, to commercialization
  • Performing a 3rdparty independent review of your business plans or technology direction
  • Engineering and construction resource gaps using our specialists
  • Expanding into new product lines to diversify in traditional biofuel or chemical sectors
  • Implementing new technologies with a vendor-neutral perspective
  • Planning expansion into new geographies from the ground up
  • Providing interim leadership or project management
  • Management of contract manufacturing resources
  • Implementing management and technical transitions following acquisitions or mergers

Our SYNTHETIC BIOLOGY COMMERCIAL EXPERTS handle projects typically involving fermentation, down stream processing, or finished product quality and QA

Fermentation

Planning and detail guidance regarding lab/bench, pilot, demonstration, and commercial design. Both purpose built or contract facilities may be evaluated and deployed. Considerations include:

  • Screening parameters: temperature, pH, osmotic pressure, OUR, agitation, cooling, shear sensitivity, and commercial feedstock
  • Commercial medium development includes: Commercial grade ingredients, avoid specialized ingredients, Availability/cost of ingredients, do any ingredients interfere with potential Down Stream Processing (DSP)
  • Design considerations related to strain deployment
  • Sterile/aseptic design, practices, and procedures including assessment of existing systems.
  • Inoculum train considerations
  • Data analysis and experimental design
  • QC monitoring and controls

Down Stream Processing (DSP)

Data analysis and experimental design, including equipment selection and testing

  • Cell separation
  • Product separation/purification
  • Concentration
  • Extraction
  • Crystallized or otherwise precipitated
  • Specialized purification
  • Formulation
  • Product drying

Finished product quality and stability considerations

  • Data analysis
  • What is the temperature sensitivity?
  • Is the product sensitive to air/O2?
  • Specialized formulations
  • Product stabilization/packaging
  • How will the product be delivered to the end user?
  • How will the product be used?
  • QC/QA and certifications

Contact us at (501)833-8511 or info@lee-enterprises.com to discuss how Lee Enterprises Consulting might assist with your business or project needs.