FDA Q-Sub Completed · MAF Filed · TRL 8

Safe injection. Cartridge economics. Zero complexity.

VaccJect™ is not another complex autoinjector. It is a sterile, single-use, cartridge-based injection platform — built on the same ISO 1mL cartridge used in billions of insulin pen injections — and filled on existing nest-and-tub PFS lines or bulk cartridge fill lines — with no infrastructure change. Simple 3-step operation. Passive auto-retraction. Designed for high-volume pharmaceutical programmes, mass vaccination, and medical countermeasure deployment.

See How It Works ↓ Request Data Pack
VaccJect device, cartridge and sterile packaging
VaccJect device rendering — cartridge loading
60mo
Stability & Sterility Validated
TRL 8
Technology Readiness Level
10×
Cold-Chain Density vs PFS
2,500+
Devices Built — Validated Process
VaccJect platform — device in hand
The Challenge
Prefilled syringes carry hidden costs
the industry can no longer afford

The conventional prefilled syringe (PFS) plus safety device model imposes significant logistical, financial, and safety burdens — particularly at the scale required by mass vaccination programmes, GLP-1 therapeutics, and CBRN medical countermeasures. VaccJect was engineered to resolve each of these structural inefficiencies.

Cold-Chain Inefficiency

PFS + safety device combinations occupy roughly 10× more cold-chain volume per dose than an equivalent cartridge-based system — a critical constraint for stockpile logistics and emergency deployment.

Needlestick Risk & Needle Phobia

Healthcare workers face ongoing needlestick injury exposure with conventional syringes. Needle phobia affects an estimated 25% of patients, reducing compliance and vaccination coverage.

Fill-Finish Complexity

Prefilled syringes require specialist fill lines. ISO cartridges used by VaccJect fill on the same nest-and-tub PFS lines already qualified at every major CMO — meaning no new infrastructure investment and no requalification for existing fill-finish partners.

Device-Drug Integration Risk

Coupling drug and device at the fill stage creates regulatory complexity, quality risk, and inflexibility. VaccJect separates the cartridge from the device until point of use — reducing both risk and cold-chain burden.

The Platform
Three steps. No exposed needle.
Automatic depth. Passive retraction.

VaccJect operates on a single continuous push — no training required for healthcare professionals or lay users. The needle is never visible before, during, or after injection. Auto-disable prevents reuse.

VaccJect device — cartridge loading
1

Load Cartridge

Insert a pre-filled ISO 1mL drug cartridge into the device at point of use. As intuitive as changing a battery. Drug stays refrigerated separately until the moment of use.

2

Activate & Inject

A single continuous push drives needle insertion, dose delivery, and depth control automatically. An informational click signals the needle-to-injection transition. No separate steps. No technique required.

3

Auto-Retraction

On plunger release, the needle retracts passively and permanently into the body of the device. Auto-disable prevents any possibility of reuse. The needle is never seen by patient or administrator.

VaccJect 3-step usage sequence
See It In Action

VaccJect mechanism animation — 3-step operation: load cartridge, place against injection site, depress plunger. Needle never exposed. Automatic retraction on completion.

Key Advantages
Designed for scale. Built for safety.
Priced for global deployment.

VaccJect delivers a unique convergence of safety, logistics, and economics — without sacrificing the regulatory simplicity of an established primary drug container.

❄️

Cold-Chain Economics

Standard ISO 1mL cartridges pack approximately 10× more doses per cubic metre of cold-chain volume compared to prefilled syringe plus safety device combinations. Critical for stockpile logistics and mass deployment.

~10×Cold-chain density improvement vs PFS
🛡️

Zero Needlestick Risk

The needle is never exposed at any stage. Passive auto-retraction is built into the device mechanism — no secondary safety add-on required. Validated across healthcare professionals, EMTs, and lay users.

0Needlestick incidents in usability studies
⚗️

ISO Cartridge — Existing Fill Infrastructure

The drug fills into a standard ISO 1mL cartridge using existing nest-and-tub prefilled syringe lines or standard bulk cartridge fill lines — both formats are already qualified and operated by every major fill-finish CMO globally. No new lines, no new equipment, no requalification. Drug and device remain separate until point of use.

ISO 1mLFills on existing nest-and-tub PFS or bulk cartridge lines — no new infrastructure
⚡

Throughput Advantage

VaccJect's 3-step administration process (vs 8–10 steps for conventional vial-and-syringe) reduces administration time per dose and eliminates dose preparation errors — critical in mass vaccination and emergency response scenarios.

3 stepsvs 8–10 steps for vial + syringe
♻️

Environmental Profile

A 6-component design — versus 12+ components in a typical autoinjector — reduces plastic waste by approximately 120 metric tonnes per million doses deployed. Bioplastic housing variants available.

120MTPlastic waste reduction per million doses vs autoinjector
💰

Low Unit Cost

A 6-component architecture and scalable automated assembly (30–60ppm validated line design) enables device-only cost targets in the range of major conventional delivery formats — without sacrificing safety features.

6 partsMinimal component count drives cost efficiency
Regulatory Path & Development Status
A fundamentally simpler regulatory path.
The facts speak for themselves.
Drug Approval
Standard drug pathway
The drug is contained in a standard ISO 1mL cartridge — the primary drug container. The drug approval follows the standard pharmaceutical approval pathway for that cartridge format. No additional device-driven regulatory burden on the drug submission.
Device Filing
MAF + 510(k) pathway
VaccJect has a Master Access File (MAF) filed with FDA, referenced by drug sponsors in their submissions. A formal FDA Q-Sub (Pre-Submission) meeting confirmed the predicate-based 510(k) pathway for device clearance — a well-understood, established route.
The Advantage
Drug and device — independent
Because the device is assembled at point of use rather than filled as a unit with the drug, the drug and device regulatory pathways remain independent. The MAF provides drug sponsors with a ready-made, FDA-reviewed device reference — accelerating their own regulatory submission.
8
Technology Readiness Level
System prototype demonstrated in operational environment. 2,500+ devices built to current frozen design on a validated assembly process. Full regulatory interactions completed. Ready for commercial partnership and scale-up.
FDA Master Access File (MAF) filed — available for drug sponsor reference
FDA Q-Sub (Pre-Submission) meeting completed — predicate-based 510(k) pathway confirmed by FDA
Drug follows standard pharmaceutical approval pathway for ISO 1mL cartridge format
Device and drug regulatory pathways are independent — MAF accelerates sponsor submissions
60-month stability, biocompatibility and sterility testing completed to ISO SPPS standards
Independent summative usability study completed — HCPs, EMTs and lay users, 0 critical errors
2,500+ devices built to current frozen design — manufacturing process validated
Manufacturing and assembly partners ISO 13485:2016 certified
2,500+ devices built to current frozen design — validated, repeatable assembly process with 100% CTQ inspection
Automated high-speed assembly designed for commercial scale — device cost competitive with established formats
Development Timeline
✓

Concept & Industrial Design

Core77 Design Award 2013. Ballpoint-pen inspiration: single continuous push. Needle never visible.

✓

Iterative Development & Design Freeze

Multiple mechanism and manufacturability iterations including single-push redesign following formative human factors study. Design now frozen.

✓

Regulatory Interactions

MAF filed with FDA. Q-Sub meeting held — positive outcome. 510(k) predicate pathway confirmed.

✓

Validation & Testing

60-month stability and sterility. Biocompatibility. Independent summative usability study. 2,500+ production-representative devices.

→

Commercial Partnership & Scale-Up

Active discussions with global pharma partners. BARDA TechWatch submission April 2026. NIH UG3 grant application in progress.

9.3
Safety score out of 10 — independent summative usability study
8.4
User-friendliness out of 10 — HCPs, EMTs and lay users
0
Critical errors recorded across all participants and user types
Independent usability evaluation results
Applications
One platform. Multiple high-value
drug delivery opportunities.

VaccJect's cartridge-based architecture is inherently versatile — the same device accommodates subcutaneous, intramuscular, or intradermal delivery variants, making it applicable across a wide range of therapeutic areas and deployment contexts.

Pharmaceutical / GLP-1

GLP-1 & Metabolic Disease

The once-weekly injectable GLP-1 market is scaling at unprecedented speed. VaccJect offers a cost-effective, patient-friendly cartridge-based alternative for subcutaneous GLP-1 administration — with cold-chain and fill-finish economics particularly suited to high-volume commercial programmes. Discussions ongoing with multiple GLP-1 developers.

Government & Defence

Medical Countermeasures (CBRN)

VaccJect's stockpile economics, lay-user usability, and scalable automated assembly directly address government requirements for chemical MCM surge-capacity deployment. The platform's cold-chain density, 3-step operation without training, and auto-disable mechanism are particularly relevant for atropine and other high-volume chemical countermeasure programmes. Active government agency engagement is underway.

Fill-Finish & CDMO Partners

Injectable Fill-Finish Partners

VaccJect cartridges fill on existing nest-and-tub PFS lines or standard bulk cartridge fill lines — both already in place at every major fill-finish CDMO. No new equipment, no requalification. The drug-device separation model means cartridges are filled and stored cold independently of device supply, then assembled at the point of use or at point of packaging.

Global Health

Contraception & Global Health

VaccJect's cost structure and cold-chain efficiency make it well-suited to global health applications including long-acting injectable contraceptives such as DMPA (Depo-Provera). A proposal to the Gates Foundation in cooperation with PATH is in development. Incepta Pharmaceuticals (Bangladesh) has been identified as a potential manufacturing partner for lower-income market supply.

Strategic Engagement
Active discussions with global pharma,
government and fill-finish leaders.

VaccJect is engaged in active partnership discussions across the pharmaceutical, government and CDMO sectors. Development agreement discussions are at an advanced stage with a major global pharmaceutical company. Government agency engagement is active across MCM and clinical research programmes. With 2,500+ devices built to a frozen, validated design and an FDA-reviewed MAF on file, VaccJect is ready to move directly into commercial partnership discussions.

"As intuitive as changing a battery — and you never see the needle at any point." — Spontaneous lay user response, independent summative usability study
VaccJect — device, cartridge and sterile packaging system
Engagement Areas
Global Pharma PartnerDevelopment agreement in progress
US Govt AgencyMCM programme engagement
US Research AgencyClinical usability programme
Validated Process2,500+ devices to frozen design
Fill-Finish CDMOCartridge fill partnership active
Glass ManufacturerCartridge supply qualified
Get In Touch
Ready to discuss VaccJect
for your programme?

We welcome enquiries from pharmaceutical companies, CDMOs, government agencies, and investors. A full technical data pack, regulatory dossier summary, and financial projections are available under NDA.

✉ simon@vaccject.com 📞 +1 609 678 6304 🌐 www.vaccject.com
Request Data Pack →

Pharma & Biotech

Licensing, development agreements, and drug-device combination partnership discussions. NDA-covered technical and commercial data available.

Government & Agencies

BARDA TechWatch engagement in progress. Full CBRN MCM technical briefing and manufacturing validation roadmap available for qualified reviewers.

CDMOs & Fill-Finish Partners

ISO 1mL cartridge fill partnership model. Existing fill-line compatibility confirmed. Contact us to discuss supply arrangement and qualification pathway.

Investors

VaccJect is seeking strategic investment aligned with commercialisation milestones including BARDA funding, first pharma partnership close, and NIH clinical usability grant.