Halcyon Injection Devices

Injection-Device Platforms Built for Commercial Scale

Halcyon provides pharmaceutical companies, biotechnology companies and pharmacy networks with configurable injection-device platforms for customer-specific drug-delivery programs.

We offer disposable autoinjector and injection systems today, with a reusable cartridge pen platform now in development. Every program is supported by device selection, customization, technical documentation, validation coordination and commercial scale manufacturing.

From device requirements to commercial supply, Halcyon simplifies injection-device sourcing and commercialization.

Discuss Your Program Request Device Information

Halcyon injection pen platform in brushed gold and white

Device Platforms

Lead Platform

Disposable Autoinjector Systems

Disposable autoinjector and injection systems for pharmaceutical programs that require simple and reliable patient administration.

The lead autoinjector platform is supported by an active US Drug Master File (DMF), giving customer programs a documented regulatory foundation in the United States.

Available configurations may include:

• autoinjector platforms
• multidose disposable pens
• fixed-dose injection systems
• cartridge- and container-based configurations

Platform selection depends on the customer's technical, therapeutic and commercial requirements.

In Development

Reusable Cartridge Pen Systems

Reusable injection-device platforms designed for compatible replaceable cartridges and patient-administered injectable programs.

This platform is in development. Regulatory master file filing and patent review are underway, and availability is expected within 8 to 12 months. We are qualifying program requirements with early customers now.

Platform configurations may support different:

• cartridge formats
• dose ranges
• dose increments
• needle systems
• device lifecycles
• branding and packaging requirements

Specific compatibility and performance requirements are evaluated on a program-by-program basis.

How Halcyon Works

Start With the Requirements

Halcyon begins with the customer's device requirements rather than forcing a pharmaceutical program into a predetermined platform.

We evaluate:

PRIMARY CONTAINER

Cartridge or compatible container system

DOSE REQUIREMENTS

Dose range, increments, volume and administration frequency

DRUG CHARACTERISTICS

Relevant physical characteristics such as viscosity and intended route of administration

DEVICE REQUIREMENTS

Reusable or disposable architecture, needle system, patient-use requirements and customization

MARKET

Target regulatory jurisdictions

SCALE

Development quantities through commercial production

Halcyon then coordinates device selection, technical review, customization, documentation, validation support and commercial supply.

Who We Serve

Pharmaceutical Companies

Injection-device platforms for current and future injectable-product programs.

Biotechnology Companies

Flexible delivery-device solutions for emerging injectable therapeutics approaching commercialization.

Generic & Biosimilar Manufacturers

Scalable device platforms for injectable products requiring patient-administered delivery systems.

Specialty & Compounding Pharmacy Networks

Empty injection-device and cartridge solutions for qualified pharmacy programs where the pharmacy independently controls the pharmaceutical formulation, filling process, dispensing and patient-specific use.

Healthcare Platforms

Injection-device infrastructure supporting appropriately licensed pharmaceutical and pharmacy partners.

Therapeutic Areas

Halcyon's device platforms may be evaluated for customer programs across areas including:

Metabolic therapies
Diabetes
Peptide therapeutics
Hormone therapies
Fertility
Biologics
Specialty pharmaceuticals

Device suitability is determined based on the requirements of each individual program.

Quality & Technical Support

Halcyon works with qualified medical-device manufacturing partners and coordinates technical documentation applicable to each selected platform.

Depending on the specific device and program, documentation may include:

• medical-device quality-system documentation
• ISO 11608 testing
• risk-management documentation
• dose-accuracy testing
• reliability testing
• biocompatibility documentation
• usability / human-factors information
• packaging and transportation validation
• aging and shelf-life information

Availability and applicability of documentation varies by platform and intended market.

Device Requirements

Tell Us What Your Program Needs

Share the requirements you know today. Our team will use them to qualify the right injection platform and plan the next technical step.

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Commercialization

From Requirements to Commercial Supply

Customer Requirements

Device Selection

Technical Evaluation

Samples

Customization

Validation & Regulatory Support

Commercial Manufacturing

Ongoing Supply

Halcyon serves as a single commercial point of coordination across this process.

Important Information

Halcyon supplies injection-device platforms and related device components. Halcyon does not supply pharmaceutical drug products as part of these device offerings.

Device specifications, validation status, regulatory status and availability vary by platform, intended use and jurisdiction. Customers are responsible for evaluating the suitability of a selected device for their specific pharmaceutical product, formulation, filling process, labeling, dispensing requirements and intended application.

References to therapeutic categories describe areas in which injection-device platforms may be evaluated and do not represent claims of compatibility with, approval for, or equivalence to any specific pharmaceutical product or branded therapy.