Background
Biotech and pharmaceutical companies around the world have killed promising development programs because of stories like this:

A brilliant academic group develops a protein drug candidate and licenses it to a biotech company, which does a great job developing the pre-clinical data and rationale for taking the protein into the clinic.  There is only one problem:  the product looks like it is going to be expensive to produce and expression yields are low.

Several production platforms are investigated, but the most cost-effective and scalable fail to produce correctly folded protein with the glycosylation that is critical to activity.  Delayed milestones and the prospect that production of clinical supplies will be more expensive than the clinical program itself leads the management team to re-think its commitment to developing this promising therapy.

Further aggravating the problem is the expectation that a successful product registration will create the need for large volumes of product to satisfy market demand.

Our Services
This is an ideal scenario for involving the experts at Phyton Biotech and our plant cell culture technology. Higher plant cells are eukaryotic and therefore able to express genes from all sources and correctly synthesize proteins of nearly all types. It does not matter if the genes come from a bacterial, fungal, plant, animal or human source. The protein from transgenic plant cells will be very much the same as from the native source. It will have the same amino acid sequence and the same folding pattern.  If the protein needs to be post-translationally modified, a plant cell expression system can be engineered to install much the same glycosylation and other post-translational modifications that mammalian cells provide.  If post-translational modification needs to be avoided, plant cells can be engineered to meet that objective.  Except in rare cases, a mammalian protein expressed by plant cell will have the same biological activity and the same degree of immunogenicity or lack thereof as the native protein.

A typical development program consists of 3 major steps:

Step 1
The Feasibility Stage starts with the scanning of the desired gene for sequences that are problematic for plant cell expression. Any such nucleotide sequences are replaced with more favorable ones that do not change the protein's amino acid sequence. The gene is then combined with a promoter, terminator and other expression enhancers/modulators. These gene cassettes are introduced into plant cells using a proprietary gene transfer method. The transformed cells are selectively grown and the highest expressing cell lines identified to produce elite high-producing cell lines for cryopreservation, upstream process development and scale up.  Preliminary protein assay, characterization and downstream processing methods are developed.  Evaluation quantities of protein are provided to the customer for confirmation of structure and function.  Genetic engineering of plant cells and preliminary determination of protein yields can be completed in as little as 10 weeks.

Step 2
The Process Development Stage includes the development of upstream and downstream isolation/purification processes that produce your protein cost-effectively in high yield.

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.

These are the core steps in our plant cell culture technology.

Advantages of Phyton Biotech's plant cell culture technology

• Higher yields of correctly folded, post-transalationally modified, and functional proteins.
• Certified cell banks for long-term production.
• Completely contained cGMP production.
• Proven scalability to meet your demand.