Companies
Precision NanoSystems
the staggered-herringbone platform (Ignite benchtop, Spark clinical, Blaze and Gemini commercial, Bio-Continuum continuous manufacturing) that set the de-facto LNP-process-development standard.
- Country
- Canada
Commercial
Cytiva company
NanoAssemblr Blaze/Gemini
Coverage
| CN | EU | US | |
|---|---|---|---|
| fill-finish-packaging | ✓ | ✓ | ✓ |
Regulatorsfdaemanmpa
Verifiable facts
| Fact | Value | Source |
|---|---|---|
| Funding | Raised approximately $25.4M to $37.6M in total funding over multiple rounds before acquisition by Danaher in 2021 medium confidence | drugdeliverybusiness.com |
| Capacity | Modular commercial formulation skid capacity of up to 384 L/h; capability to produce up to 240 million vaccine doses annually upon completion of biomanufacturing facility | cdn.cytivalifesciences.com · rtf.vc · prnewswire.com |
| Certification | ATEX and IECEx rated systems; compliant with FDA 21 CFR Part 11 for electronic records | cdn.cytivalifesciences.com |
| Regulatory approval | Quality Management System aligned with ICH Q10 and 21 CFR Parts 210 and 211 | cdn.cytivalifesciences.com |
| Production site | Vancouver, British Columbia, Canada and South San Francisco, California, USA | cdn.cytivalifesciences.com · news-medical.net · richmondscientific.com |
Independent sources: cdn.cytivalifesciences.com · drugdeliverybusiness.com · news-medical.net · prnewswire.com · richmondscientific.com · rtf.vc
Technologies
| Name | Cluster | Risk | |
|---|---|---|---|
| mRNA / LNP manufacturing equipment | fill-finish-packaging | Low | → |
Compiled by BIOECON from primary sources.
Compliance
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