Development and manufacturing for injectable products

The market for sterile injectables is experiencing rapid growth, driven by major trends. Biologics and vaccines are at the heart of this evolution, with increased demand for reliable and secure solutions. The post-Covid crisis revealed the limitations of glass bottles, leading to shortages and accelerating the search for alternative technologies like Blow-Fill-Seal (BFS). At the same time, sustainability and efficiency issues are becoming essential: cost reduction, cold-chain optimization, and waste reduction are now priorities for the pharmaceutical industry.

Healthcare professionals are looking for devices that meet these requirements:

  • Ready-to-use, to simplify preparation and save time.
  • Single-dose, to prevent cross-contamination and ensure patient safety.
  • Compatible with sensitive formulations (pH, temperature, oxygen, light), to preserve the integrity of the most fragile products.

Our proprietary technologies

Euroject® - Injectables

Euroject®, our technology based on the Blow-Fill-Seal (BFS) process:

  • Single-dose injectable device: sterile, unbreakable, preservative-free.
  • Adaptable volumes: 0.25 to 4 mL (up to 2.5 mL delivered with precision).
  • Compatibility with biologics and vaccines: proven stability after freeze/thaw cycles (-80°C).
  • Large-scale production: up to 1 billion doses/year at our dedicated Amiens site.
  • Sustainability: recyclable material (LDPE), lightweight design to reduce emissions.
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Filling and sealing for biologics and vaccines

Fill & Finish

Unither Pharmaceuticals offers a Fill & Finish service that guarantees the sterile and secure production of injectables, biologics, and vaccines thanks to innovative Blow-Fill-Seal (BFS) technology. This process includes primary container formation, aseptic filling, and hermetic sealing in a controlled environment, with quality controls compliant with ISO, FDA, and EMA standards. Adapted for sensitive formulations (pH, temperature, oxygen, light), it ensures dosing precision, preservative-free products, and optimal safety.

Thanks to our global expertise in injectable CDMO, our regulatory audits, and our flexibility, we are a trusted partner for the development and market launch of innovative injectable products.

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Why trust us?

1 billion doses

Injectable dose capacity

-80°C stability

Compatible with the cold chain

Sustainability recyclable materials

reduced emissions thanks to a compact design.

Sensitive formulations

management of temperature, pH, oxygen, and light constraints.

Do you have a project?

Talk to our experts

Marlish RATNAKUMAR

Business Development Manager

Alexandre FONTAYNE

CSO

Got questions? - Consult our FAQ

Yes, in many cases: it is a single-dose, ready-to-inject device. It offers cost reduction and reduced handling and ensures efficient volume delivery (0.47–0.49 mL delivered according to tests). It also addresses vaccine equity issues: no glass, simplified logistics, and greater facility for healthcare providers.

Unither ensures the sterility and integrity of injectables through:

  • A fully aseptic BFS process: the container is formed, filled, and sealed in a single step, without human intervention and in a closed environment.

  • Strict compliance with the revised Annex 1 of the European GMPs, including an enhanced contamination control process.

  • Systematic verification of seal integrity (pressure tests at 3 bar, with zero failure rate observed on qualified batches).

  • Very low particle generation, including upon opening after mechanical stress, thus contributing to patient safety.

• BFS lines suited to small and large volumes
• Ability to package millions of units at commercial scale
• Sites in Europe and the United States, and growing
• Rapid distribution of vaccine batches (e.g., 3 L in 6 min 53 seconds), demonstrating a high level of operational efficiency for vaccination campaigns

This multi-site capacity ensures supply is guaranteed and allows for a competitive time-to-market.

Yes. Despite the use of heat during plastic molding, the Blow-Fill-Seal (BFS) process is very fast, which limits exposure and preserves the integrity of heat-sensitive formulations. Clinical studies have shown that BFS-packaged vaccines, such as flu vaccines or GSK’s Rotarix®, maintain their efficacy and stability, equivalent to those obtained in glass vials. BFS is therefore a safe and innovative option for injectable or oral vaccines and biological products. The very rapid cycle of BFS limits thermal exposure (<40°C over the majority of the volume) and preserves the integrity of biological products, including recombinant protein vaccines. This has been demonstrated by several studies (GSK, MedImmune, Unither).