CDMO Services

The unique capabilities of our Botanical Synthesis process enable us produce molecules for Health & Wellness products for the Pharmaceutical, Nutraceutical, Cosmeceutical, and Nutrition verticals.

As a Contract Development and Manufacturing Organization (CDMO), we are actively researching new molecules to develop on our platform. This Services model allows industry partners to explore new plant-based compositions with magnified levels of their targeted phyto-chemicals.

BioHarvest Sciences Botanical Synthesis CDMO has the Potential to Become an Emerging Force in Plant-based Biologics

Multiple CDMO Partner Molecules Currently in Research Stage

  • Expansion into the contract development & manufacturing organization (CDMO) market is built upon the success of our commercially validated botanical synthesis technology process
  • CDMO unit enables BioHarvest to offer disruptive innovation via Botanical Synthesis for market leaders in cosmeceutical, nutraceutical & food nutrition verticals with unique plant molecules
  • Development of plant-based Biologics+ molecules create a safer, faster and less expensive pipeline of molecules for next-gen therapeutics vs existing small and complex molecule solutions available to pharma.
  • CDMO partners own all IP rights to the new developed molecules
  • Biologics+ can be pursued through full FDA-approved drugs in both regulatory approval pathways: Biological drugs and Botanical drugs
  • CDMO unit provides unique optionality on top of existing high performing products business

CDMO Staged Development Process

Development Timeline:     15-24 Months

Non-Recurring Engineering (NRE) Costs: $1.8M – 2.5M, paid for by CDMO partner

  • Process begins with customer initiation where specific plant and compounds is chosen; cell culture development and elicitation completed
  • Within 6-9 months customer can receive kilograms of molecules for development and clinical trials
    • Requires $0.5-1M non-refundable, milestone driven capital commitment from customer
  • Development completes with industrial production of chosen compound and royalty model put into place with customer (expected to be ~80% gross margins)
Botanical Synthesis CDMO Development Stages

DEMAND CENTERS AND ADDRESSABLE MARKET

CDMO Building Blocks for Growth

Sample Molecule Use Case - VINIA® Red Grape Cells (RGC)

Vinia® - A potential adjunct for pharma to make active solutions more effective

The top 10 highest grossing drugs in the USA only have 4.1%-25% efficacy

Vinia

RGC’s ability to enhance arterial, venous, and capillary dilation significantly could make pharmaceuticals more efficacious as actives can now reach the far corners of our extremities and organs, impacting significantly more cells.

  with vinia                without vinia                      

 

We are implementing Clinical Trial Pilot programs to prioritize indications

To best prioritize the development of our Red Grape Cells (RGC) and Olive Cell (Products) into FDA approved API’s, Bioharvest is currently implementing a number of clinical trial pilots to allow us to select the optimal indications to partner with Pharma in the Investigational New Drug (IND) Drug Development Process

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