Ampulis
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
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.
AFS
Custom drug delivery device designed as an all-in-one solution for delivering oncology medications, emergency medications, and dermatological applications using an all-glass hermetically-sealed ampoule.
Ampulis AFS Emergency Use Injector
The Ampulis AFS reduces steps involved in transferring emergency medications from vials to syringes, featuring integrated ampoule storage and breaking tool for rapid drug delivery.
Ampulis Flowen
A prefilled syringe alternative containing liquid formulations in all-glass, hermetically-sealed ampules with an integrated filter to remove particulate.
Ampulis Pristal
A delivery platform containing lyophilized formulation and diluent in the same device, allowing reconstitution via pulling upward on the plunger rod.
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.
AFS
Custom drug delivery device designed as an all-in-one solution for delivering oncology medications, emergency medications, and dermatological applications using an all-glass hermetically-sealed ampoule.
Ampulis AFS Emergency Use Injector
The Ampulis AFS reduces steps involved in transferring emergency medications from vials to syringes, featuring integrated ampoule storage and breaking tool for rapid drug delivery.
Ampulis Flowen
A prefilled syringe alternative containing liquid formulations in all-glass, hermetically-sealed ampules with an integrated filter to remove particulate.
Ampulis Pristal
A delivery platform containing lyophilized formulation and diluent in the same device, allowing reconstitution via pulling upward on the plunger rod.
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.