ApiJect Systems America, Inc.
ApiJect is a medical technology company dedicated to transforming drug delivery through innovative prefilled injection devices. Their platform combines Blow-Fill-Seal (BFS) manufacturing with attachable components to create scalable, affordable, and safe prefilled injectors, aiming to improve accessibility, safety, and efficiency in injections worldwide.
Industries
Nr. of Employees
medium (51-250)
ApiJect Systems America, Inc.
Stamford, Connecticut, United States, North America
Products
Single-dose prefilled injector (BFS container with attachable needle hub)
A single-use, aseptically filled polymer container combined with an attachable needle hub to create a ready-to-use prefilled injector intended to deliver up to ~1 mL via intramuscular or subcutaneous administration.
Single-dose prefilled injector (BFS container with attachable needle hub)
A single-use, aseptically filled polymer container combined with an attachable needle hub to create a ready-to-use prefilled injector intended to deliver up to ~1 mL via intramuscular or subcutaneous administration.
Services
Proof-of-Concept BFS compatibility testing
Feasibility testing services that assess whether a drug or vaccine formulation can be reliably filled in BFS containers using small volumes to reduce material needs during early evaluation.
Device prototyping and mold development
Tooling, mold design, prototype machining, and iterative container/hub design services to prepare components for scale-up on BFS and injection molding lines.
Non-GMP feasibility, formulation and tech transfer support
Pharmaceutical development services including formulation assessment, sterile-filtration, compounding, and technical transfer planning for combination product programs from lab scale toward commercial readiness.
BFS training and partner enablement
Training programs and partnership support to transfer BFS operational knowledge and facilitate third-party manufacturing adoption.
Commercial fill-finish via manufacturing partners
Provisioning of large-volume, cGMP-capable fill-finish capacity through dedicated lines and collaborations with established manufacturing partners to produce prefilled injectors at scale.
Proof-of-Concept BFS compatibility testing
Feasibility testing services that assess whether a drug or vaccine formulation can be reliably filled in BFS containers using small volumes to reduce material needs during early evaluation.
Device prototyping and mold development
Tooling, mold design, prototype machining, and iterative container/hub design services to prepare components for scale-up on BFS and injection molding lines.
Non-GMP feasibility, formulation and tech transfer support
Pharmaceutical development services including formulation assessment, sterile-filtration, compounding, and technical transfer planning for combination product programs from lab scale toward commercial readiness.
BFS training and partner enablement
Training programs and partnership support to transfer BFS operational knowledge and facilitate third-party manufacturing adoption.
Commercial fill-finish via manufacturing partners
Provisioning of large-volume, cGMP-capable fill-finish capacity through dedicated lines and collaborations with established manufacturing partners to produce prefilled injectors at scale.
Expertise Areas
- Blow-Fill-Seal manufacturing
- Prefilled injector and combination product development
- Aseptic fill-finish (cGMP)
- Prototype tooling and mold development
Key Technologies
- Blow-Fill-Seal (BFS)
- Precision injection molding
- Aseptic fill-finish processes (cGMP)
- Temperature management for cold-chain sensitive formulations