Background
Biotech and pharmaceutical companies around the world have killed promising development programs because of stories like these:
A small molecule is isolated from a rare plant and found to have disease fighting properties for an illness for which no suitable treatment option exists today. The compound is determined to have commercial value and an extensive R&D program is developed. There is only one snag in the plan--the compound can't be produced!
The original plant material was obtained from a remote and inaccessible part of the world. Returning to the source, the plant is confirmed to produce minute amounts of the target compound and only during a limited time of the year. Even worse, special climate conditions are required for the plant to grow and there is a risk that it will become extinct due to ongoing climate changes. Cultivation is hampered by slow growth and unreliable production of the molecule of interest.
And to make things worse, this compound's complex structure rules out chemical synthesis as an economical sourcing solution.
Our Services
This is an ideal scenario for involving the experts at Phyton Biotech. Not only can we develop a production system, we also have the factory to manufacture your small molecule in a cGMP environment. We can achieve higher yields than Nature can under the best of circumstances.
A typical development program consists of 3 major steps:
Step 1
The Feasibility Stage establishes the baseline production level for the plant cell culture process and defines the productivity enhancement required in the subsequent Process Development Phase. Working with client companies Phyton will assist with an evaluation of the intellectual property environment regarding Freedom to Operate and patentability. The duration of this phase is typically 1 year.
Step 2
The Process Development Stage includes the development of fermentation and downstream isolation/purification processes that produce your product cost-effectively in high yield. The duration of this phase is typically 1.5 years.
Step 3
The Commercialization Stage involves the production of cell banks for long term operation, process documentation, transfer of technology from R&D to manufacturing, process scale up and validation, and regulatory approval. The duration of this phase is typically 2-3 years.
These are the core steps in the application of Phyton's technology.
Advantages of Phyton Biotech's plant cell culture technology
- Higher yields than production in whole plants.
- Certified cell banks for long-term production.
- Completely contained cGMP production that eliminates the risks of Nature.
- Almost unlimited scalability to meet your demand.
Conclusion
The ideal small molecule candidate for Phyton's technology is a secondary plant metabolite that is expensive and difficult to isolate in sufficient quantity from whole plants. We might already have your source plant in our extensive bank of cryo-preserved plant cell lines. |