Technical assessment and roadmap
We help you build a competitive
- allowing you to focus
on succeeding in the market.
We help you build a competitive manufacturing foundation - allowing you to focus on succeeding in the market.
What we do
What: We assess the technical potential in delivering your innovation – the expression system, the strain base, yield potential, investments required and the best way forward to regulatory approval of a compound which is ready for commercialization.
How: We put together a team of the most experienced experts in industrial biotech backed by proprietary data.
World class strains and optimization
What: We provide access to and optimize high performance strain platforms and production media across multiple expression systems. The aim is to significantly improve yields and stability.
How: We operate with a World class strain library, know-how, and toolbox as our backbone across several expression systems. The strains have been tested and optimized over multiple years to deliver highly efficient manufacturing processes in factories across the World and to ease regulatory approval in key markets.
Scaling for commercial trial volumes
What: We build your scale-up process and provide volumes for testing your innovations in the market. We deliver a concept for large scale protein manufacturing.
How: A state of the art scaling facility and a team with World class know-how to take your innovation to commercial trial volumes – cost effectively.
Enabling large scale manufacturing
What: We provide access to a high quality, proven low investment way for you to manufacture on a large scale.
How: Production in state-of-the-art standardized modules with the needed flexibility to accommodate the needs of your process. We leverage partnerships with large capacity suppliers as an efficient production platform for you.
Frequently asked questions
21st.BIO is licensing a library of microbial production strains and molecular tools from Novozymes A/S. The strains have been developed over a period of 40 years and are being used for manufacturing of multiple Novozymes enzymes and products.
We are developing production strains for our clients under a licensing agreement with Novozymes A/S. The developed strains remain the property of Novozymes and 21st.BIO and are licensed to clients for manufacturing of their proprietary molecules.
Development of a production strain and process which is ready for pilot up-scaling takes 18-24 months. Typically, we conduct strain and process development projects in 6-month phases, that look like this:
Phase I: Expression confirmation in small scale with a selected set of host strains which are transformed with a limited number of genetic elements.
Phase II: Optimization of expression levels to consistent high fermentation titers in selected bacterial and/or fungal host strains.
Phase III: Strain optimization of selected bacterial and fungal hosts to achieve consistent yield in lab-scale fermenters and assess manufacturability. A library of strain backgrounds having engineered functions which affect protein yield and stability will be used. Controlled fermentation of lead strains is performed in lab bioreactors.
Phase IV, in parallel with Phase III: Development of processes for recovery, purification and stabilization of molecule.
After the completion of Phase IV, the strain and processes are ready for up-scaling in a pilot facility. This may take between 3-9 months. When the process runs consistently at pilot scale, we can assist with technology transfer to full scale manufacturing.
A strain and process development project is priced based on four elements:
- Time & Materials covering the manning, facilities, tools, and standard materials needed during the project phases to achieve the deliverables agreed on.
- Success and Technology Fees: As our expertise and technologies prove their worth, we command a Success Fee. Typically, at the end of each project phase. A Technology Fee is triggered by the decision to up-scale the strain and processes developed in Phase I-IV to pilot and manufacturing scale.
- After commercialization we require a royalty fee on sales of molecules produced by use of the developed strain and processes.
- During the commercial phase we offer continuous improvements of the manufacturing processes. We use a value sharing model for implemented productivity improvements.