ApiJect


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

Health Care
Manufacturing
Medical Device
Pharmaceutical Manufacturing

Nr. of Employees

medium (51-250)

ApiJect

Stamford, Connecticut, United States


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.

Blow-Fill-Seal

An advanced aseptic process used to fill-finish billions of sterile liquid pharmaceutical doses every year by forming, filling, and sealing plastic containers from heated resin in a continuous process.

ApiJect Prefilled BFS Injector

A prefilled Blow-Fill-Seal (BFS) injector designed for pharmaceutical drug delivery, customizable for specific drug products and intended markets.

BFS Molds

High-quality molds designed for both shuttle and rotary blow-fill-seal (BFS) machines, supporting development processes and commercial production volumes.

Prefilled ApiJect Injector

An assembly that brings together an aseptically-filled Blow-Fill-Seal (BFS) container and a pen needle-style Needle Hub to reliably deliver injectable vaccines and medicines.

Feasibility Filling

In-house blow-fill-seal (BFS) filling service and asset suite for drug device development and compatibility testing.

View All Products

Services

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.

Tooling, mold design, prototype machining, and iterative container/hub design services to prepare components for scale-up on BFS and injection molding lines.

Pharmaceutical development services including formulation assessment, sterile-filtration, compounding, and technical transfer planning for combination product programs from lab scale toward commercial readiness.

Training programs and partnership support to transfer BFS operational knowledge and facilitate third-party manufacturing adoption.

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
  • Show More (5)

Key Technologies

  • Blow-Fill-Seal (BFS)
  • Precision injection molding
  • Aseptic fill-finish processes (cGMP)
  • Temperature management for cold-chain sensitive formulations
  • Show More (4)

News & Updates

ApiJect Systems, Corp. announced it has added product development capabilities, including Proof-of-Concept studies that use as little as 8 liters of vaccine or drug product to test compatibility in Blow-Fill-Seal (BFS) using ApiJect prefilled injector technology. The new capability aims to facilitate testing and development for pharmaceutical companies.

ApiJect Systems, Corp. announced the expansion of its executive leadership team with Russell (Bo) Kowalczyk as Senior Vice President of Commercial Development. Kowalczyk brings extensive experience in business development, strategic planning, and operations to support ApiJect's growth and innovation in drug delivery technology.

ApiJect was awarded a $138 million contract supported by the U.S. Department of Health and Human Services and the Department of Defense to accelerate the build-out of domestic surge capacity for prefilled syringes, supporting emergency and pandemic response efforts.


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