Contrary to expectations, regulatory approvals were not the main challenge in scaling a COVID vaccine during the pandemic. The most significant constraint was the global supply chain for critical imported biomanufacturing components like filters and resins, as every country competed for the same limited resources.
By bypassing the creation of stable transgenic cell lines, molecular farming uses transient expression to turn plants into living bioreactors. This accelerates development, allowing protein expression within days and harvesting within a week — a stark contrast to the months required by traditional methods.
Fears of regulatory hurdles for new manufacturing platforms may be overstated. Regulators, familiar with technologies like molecular farming for decades, prioritize the final product's purity, safety, and efficacy. The platform's novelty is secondary to robust scientific data proving the end product's quality.
To manage the long, costly timeline of therapeutic development, a biotech can create revenue-generating subsidiaries. One can offer its platform as a service (like a CDMO), while another sells lower-regulation products like cosmetic ingredients for faster market entry. This provides crucial cash flow to sustain the core drug pipeline.