Ampulis, Inc.
Developer of alternative prefilled-syringe delivery platforms that combine all-glass hermetic primary containment and integrated reconstitution/filtration mechanisms. Focus areas include device design for lyophilized and liquid formulations, human-factors-driven usability for point-of-care and self-administration, analytical and verification testing to support regulatory filings, and staged programs that move prototypes to cGMP clinical builds and scaled manufacturing via contract partners.
Industries
N/A
Products
Device for lyophilized formulations (integrated reconstitution device)
A delivery device that houses lyophilized drug and diluent in separate compartments and enables in-device reconstitution by plunger action; intended to simplify and make reconstitution safer.
Device for liquid formulations (hermetic ampoule prefilled-device)
A prefilled-device that uses all-glass hermetic ampoules to contain liquid formulations, provides intrinsic container-closure integrity, and uses a twist/break mechanism plus integrated filter to transfer and deliver drug.
Device for lyophilized formulations (integrated reconstitution device)
A delivery device that houses lyophilized drug and diluent in separate compartments and enables in-device reconstitution by plunger action; intended to simplify and make reconstitution safer.
Device for liquid formulations (hermetic ampoule prefilled-device)
A prefilled-device that uses all-glass hermetic ampoules to contain liquid formulations, provides intrinsic container-closure integrity, and uses a twist/break mechanism plus integrated filter to transfer and deliver drug.
Services
Feasibility assessment
4–6 week assessment to evaluate device fit for a specific drug, including costing, timelines, and go/no-go recommendations.
Custom device development and prototyping
6–8 month custom development program including design updates, prototype assembly, and testing tailored to a drug's specifications.
Design verification and regulatory package preparation
Completion of mechanical, analytical, and human factors testing culminating in a report package intended for regulatory filings.
cGMP clinical-build manufacturing
Production of cGMP-built units for clinical testing with traceability and Device History Records (DHRs).
Scale-up and manufacturing transfer
Support for scale-up to production volumes via established CMO partners, including supply chain and automation planning.
Feasibility assessment
4–6 week assessment to evaluate device fit for a specific drug, including costing, timelines, and go/no-go recommendations.
Custom device development and prototyping
6–8 month custom development program including design updates, prototype assembly, and testing tailored to a drug's specifications.
Design verification and regulatory package preparation
Completion of mechanical, analytical, and human factors testing culminating in a report package intended for regulatory filings.
cGMP clinical-build manufacturing
Production of cGMP-built units for clinical testing with traceability and Device History Records (DHRs).
Scale-up and manufacturing transfer
Support for scale-up to production volumes via established CMO partners, including supply chain and automation planning.
Expertise Areas
- Drug-delivery device development
- Lyophilized product reconstitution
- Primary packaging for stability (hermetic glass ampoules)
- Human factors and usability evaluation
Key Technologies
- All-glass hermetic ampoule primary packaging
- Lateral dual-chamber reconstitution mechanism
- Integrated particulate filtration
- Luer interface compliant with ISO 80369-7