Blow-Fill-Seal Ampoule
As a leader in Blow-Fill-Seal technology for over thirty years, BioCina offers unit dose and multidose formats with unrivaled, high-speed manufacturing. We offer a wide variety of dosage forms and a broad range of expertise and differentiated solutions. With 120M+ unit capacity and expertise at every stage of the drug development life cycle from early-stage drug development to full-scale manufacturing, distribution, tech-transfer, stability studies, and life cycle management, we have the capabilities to support you in delivering your product to market ahead of schedule.
Blow-fill-seal is an advanced aseptic processing and packaging technology. It is a completely automated and enclosed formulation and filling system that manufactures, fills, and seals ampoules in a single process, significantly reducing the risk of contamination compared relative to traditional vial and bottle filling operations. BioCina’s blow-fill-seal technology offers a variety of volumes and presentations enabling our clients to bring innovative delivery systems to market.
Capabilities: BioCina offers products aseptically filled and terminally sterilized in low-density polyethylene plastic ampoules.
- Ampoule fill volumes range from 1mL to 30mL
- Wide range of batch sizes from 105L to 25,000L
- 120M+ unit capacity
- Wide range of head-molds available:
- Flow wrapping capability
Blow-Fill-Seal capabilities are delivered using:
- Highly automated advanced aseptic processing technology
- Automated inspection technology
- Integrated robotics for downstream handling and packaging
- 7x Rommelag Blow-Fill-Seal machines
- 24×7 operating capacity
BioCina specializes in the production of sterile single dose plastic presentations which offers many benefits relative to multi-dose and glass presentations including:
- Tamper-proof and counterfeit-resistant presentations ensures precise dosing and dosage compliance in all settings, reducing medical and legal risks for patients, providers, and payors
- Shatter resistant presentations with no sharp edges reduces the risk of injury to patients and facility personnel
- Preservative free formulation options
- Freezable containers
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.
Our Expertise On Demand
Thought Leadership & Resources
