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
Nr. of Employees
small (1-50)
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
4–6 week assessment to evaluate device fit for a specific drug, including costing, timelines, and go/no-go recommendations.
6–8 month custom development program including design updates, prototype assembly, and testing tailored to a drug's specifications.
Completion of mechanical, analytical, and human factors testing culminating in a report package intended for regulatory filings.
Production of cGMP-built units for clinical testing with traceability and Device History Records (DHRs).
Support for scale-up to production volumes via established CMO partners, including supply chain and automation planning.
4–6 week assessment to evaluate device fit for a specific drug, including costing, timelines, and go/no-go recommendations.
6–8 month custom development program including design updates, prototype assembly, and testing tailored to a drug's specifications.
Completion of mechanical, analytical, and human factors testing culminating in a report package intended for regulatory filings.
Production of cGMP-built units for clinical testing with traceability and Device History Records (DHRs).
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
News & Updates
Attendance and presentation on the ampoule-filled syringe platform; discussions with pharmaceutical companies about biologics compatibility, viscosity range, reconstitution, and higher dose volumes.
Attendance and presentation on the ampoule-filled syringe platform; engagement with industry partners on compatibility with biologics, viscosities, and dose volume considerations.
Article describing a lateral dual-chamber syringe concept that places chambers side-by-side to achieve consistent glide force, shorter plunger stroke, and simpler manufacturing for improved reconstitution usability and scalability.
Attendance and presentation on the ampoule-filled syringe platform; discussions with pharmaceutical companies about biologics compatibility, viscosity range, reconstitution, and higher dose volumes.
Attendance and presentation on the ampoule-filled syringe platform; engagement with industry partners on compatibility with biologics, viscosities, and dose volume considerations.
Article describing a lateral dual-chamber syringe concept that places chambers side-by-side to achieve consistent glide force, shorter plunger stroke, and simpler manufacturing for improved reconstitution usability and scalability.