Companies
Spark Therapeutics
Clinical pipelines — Accelerated trials.
- Country
- United States
Coverage
| CN | EU | US | |
|---|---|---|---|
| therapeutics-platforms | ✓ | ✓ | ✓ |
Regulatorsfdaemanmpa
Verifiable facts
| Fact | Value | Source |
|---|---|---|
| Funding | $50 million initial financing | prnewswire.com |
| Capacity | 500,000-square-foot Gene Therapy Innovation Center under construction | pharmaceutical-technology.com |
| Certification | current good manufacturing practices (cGMP) certification for manufacturing facility | sparktx.com |
| Regulatory approval | FDA approval for LUXTURNA (voretigene neparvovec) for RPE65 mutation-associated retinal dystrophy in 2017 | sparktx.com · sec.gov |
| Production site | Philadelphia, Pennsylvania (existing facility and new Gene Therapy Innovation Center under construction) | sparktx.com · pharmaceutical-technology.com |
Independent sources: pharmaceutical-technology.com · prnewswire.com · sec.gov · sparktx.com
Technologies
| Name | Cluster | Risk | |
|---|---|---|---|
| In-vivo gene therapy: AAV and lentiviral vectors | therapeutics-platforms | Medium | → |
Compiled by BIOECON from primary sources.
Compliance
Bioecon is an information intermediary; it is not a regulator, a certification body, or a legal advisor. When working with public-sector customers (procurement under 44-FZ / 223-FZ), Bioecon acts solely as an independent analytical platform, with no remuneration from suppliers.