Ampulis provides an Ampoule-Filled Syringe (AFS) platform that integrates a hermetically sealed, all-glass ampoule within a syringe. This design eliminates drug-device interactions and enhances drug stability by preventing air and moisture ingress, streamlining the path to market for pharmaceutical companies.
Funding
Funding not disclosed
Founders
Product
Problem
Traditional prefilled syringes (PFS) can introduce drug-device interactions and require complex assembly processes, leading to extended drug development timelines and potential compromises in drug stability. This can delay the availability of critical medications for patients.
Solution
Ampulis offers an Ampoule-Filled Syringe (AFS) platform that integrates a hermetically sealed, all-glass ampoule within a familiar syringe format. This design eliminates silicone and rubber components, mitigating drug-device interactions and enhancing drug stability by preventing air and moisture ingress. The AFS platform streamlines the path to market by separating device assembly from fill-finish operations, potentially reducing development timelines by up to three years. It provides a scalable solution suitable for a range of therapeutic areas, including oncology, emergency medicine, and dermatology, from clinical trials through commercialization.
Target Audience
Pharmaceutical and biotechnology companies developing new drugs or seeking improved delivery systems for existing formulations, particularly those with stability challenges or requiring precise dosing.
Features
- Ampoule-Filled Syringe (AFS) platform combining an all-glass, hermetically sealed ampoule with a syringe delivery mechanism.
- Eliminates silicone and rubber components to prevent drug-device interactions and ensure drug purity.
- Hermetic sealing provides a barrier against air and moisture ingress, enhancing drug stability.
- Integrated filter to remove glass particulate during drug delivery.
- Supports custom dose volumes ranging from 0.5 mL to 12 mL.
- Offers various tip options including Luer connections, staked needles, and topical dispensers.
- Capable of handling reconstitution of lyophilized drugs and diluents.
- Facilitates point-of-care administration, reducing the need for pre-administration preparation by pharmacists.
- Designed for rapid and safe drug delivery, particularly for emergency medications and cytotoxic drugs.
- Supports customization for branding, labeling, and specific application requirements.