Page 258 - Binder2
P. 258

1. Build Industrial-Grade Expression Platforms

               The science is sound, but the platform must scale.
               We need plant-based expression systems that deliver
               repeatable, GMP-compliant, pharma-grade outputs—
               not just promising yields in research labs.

               That means:


                   •  Codifying best practices for plant transformation
                       and protein folding
                   •  Optimizing growth conditions for consistent
                       biomass and therapeutic load
                   •  Developing standard operating procedures for
                       harvest, processing, and formulation
                   •  Proving that lettuce, duckweed, and rice aren’t just
                       model organisms—they’re manufacturing
                       workhorses


               If edible biologics are to be taken seriously by investors,
               regulators, and healthcare systems, they must match the
               reliability, quality control, and scalability of traditional
               bioreactors.


               We don’t need perfect plants.
               We need platforms that perform—batch after batch, dose
               after dose.




               2. Define New Regulatory Precedents

               Edible biologics don’t fit neatly into existing drug
               categories.
               They blur the lines between food, pharma, and device—and
               that ambiguity can stall progress.

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