Summary
Regenosine aims to validate analytical methods and cGMP processes for manufacturing RgnA09M, a liposomal adenosine product, and produce a 1-liter sterile cGMP batch for Phase 1b/2a clinical trials to treat osteoarthritis.
Treatment and prevention of osteoarthritis with an intra-articular disease-modifying regenerative therapy
US · IL
NIH-NIAMS
grant
awarded
#nih-5SB1AR084381-02
What they want
The project involves two primary aims: 1) Validation of analytical methods and the cGMP process for manufacturing RgnA09M, a shelf-stable liposomal adenosine formulation designed for regenerating cartilage in osteoarthritis patients. 2) Manufacturing of a 1-liter sterile cGMP batch of RgnA09M, which is required for the company to proceed with clinical Phase 1b/2a trials as mandated by the FDA before commercialization.
Deliverables
- Validated analytical methods for RgnA09M
- Validated cGMP process for manufacturing RgnA09M
- 1-liter sterile cGMP batch of RgnA09M
Technical requirements
- Liposomal adenosine product (RgnA09M)
- Proprietary, novel formulation
- Shelf-stable formulation with 15-day bioavailability
- cGMP process compliance for manufacturing
- Sterile manufacturing
Eligibility & certifications
cGMP
Risks & flags
Incumbent: Regenosine
Market context
inferred from NAICSManufacturing (chemicals, plastics, materials)
NAICS 325412
- US market size
- $1.4T
- Typical award
- $50K – $100M
Typical buyers
DoDEPADOE
Commonly required
ISO 9001REACH
Sector-level estimate — full code lookup not yet in catalog.
