Blow-Fill-Seal Ampoules for Sterile Fill-Finish Manufacturing
As a sterile fill-finish CDMO, BioCina has been a leader in Blow-Fill-Seal (BFS) technology for over thirty years, offering unit dose and multidose formats with unrivaled, high-speed sterile fill-finish manufacturing. We provide a wide variety of dosage forms, supported by deep expertise and differentiated solutions across the product lifecycle. With 200M+ unit capacity and capabilities spanning clinical to commercial manufacturing, including distribution, tech transfer, stability studies, and lifecycle management, we support efficient and reliable delivery of your product to market.
Blow-Fill-Seal (BFS) technology is an advanced aseptic processing and packaging solution. It is a fully automated and enclosed system that forms, fills, and seals ampoules in a single process, delivering enhanced contamination control compared to traditional vial and bottle filling operations. As a trusted sterile fill-finish CDMO, BioCina’s BFS technology supports a variety of volumes and presentations, helping clients bring innovative and scalable delivery systems from clinical development through to commercial manufacturing.
Sterile Fill-Finish Capabilities Using Blow-Fill-Seal Technology.
As a leading sterile fill finish CDMO, BioCina delivers advanced Blow-Fill-Seal capabilities for aseptic, high-speed, and contamination-controlled manufacturing.
- Ampoule fill volumes from 1 mL to 30 mL
- Batch sizes from 105 L to 25,000 L for clinical and commercial production
- High-capacity sterile fill-finish manufacturing (up to 200M+ units annually)
- Wide range of mold configurations
- Flow-wrapping and packaging integration
Advanced BFS Technology for Sterile Fill-Finish Manufacturing
- Highly automated aseptic Blow-Fill-Seal processing
- Integrated inspection and quality control systems
- Robotics for downstream handling and packaging
- Multiple Rommelag BFS machines
- 24/7 manufacturing capacity
Benefits of Blow-Fill-Seal for Sterile Fill-Finish Manufacturing
Blow-Fill-Seal technology offers significant advantages for sterile fill-finish manufacturing, particularly for single-dose liquid products.
- Tamper-evident and contamination-resistant packaging
- Reduced risk compared to traditional vial and syringe filling
- Improved dosing accuracy and patient safety
- Shatter-resistant plastic ampoules
- Preservative-free formulation compatibility
- Suitable for cold-chain and frozen applications
Comprehensive Services for Your Every Need
Quality &
Regulatory
We produce mRNA drug substance of the highest quality standards, in full compliance with all global regulatory requirements.
Process
Development
BioCina’s expert Poly Nucleic Acid Products team is equipped to develop end-to-end mRNA manufacturing processes up to 1 L IVT and 1 L LNP encapsulation scale.
Analytical
Development
Robust and compliant test methods are developed to ensure the quality, safety and efficacy of all products manufactured at BioCina.
cGMP
Manufacturing
End-to-end cGMP manufacturing of LNP encapsulated mRNA, including cell line development and cGMP manufacture of template plasmid DNA.
Technology
Transfer
Our highly structured approach, including comprehensive gap analysis and robust risk mitigation, ensures reliable technology and process transfers.
Sterile Fill-Finish Insights & Resources
Explore insights, case studies, and innovations in sterile fill-finish manufacturing and Blow-Fill-Seal technology
Partner with a Sterile Fill Finish CDMO
Partner with Collaborate with BioCina's sterile fill finish CDMO team to deliver high-quality, scalable, and compliant manufacturing solutions.a Sterile Fill Finish CDMO