Precision Pre-Filled Syringes, Cartridges and Pens
Fully closed robotic aseptic filling for pre-filled syringes, cartridges, and injectable device programs. Precision-filled, with flexible batch sizes from first-in-human through to program completion, plus hand assembly of auto-injectors and pens.
Robotic Aseptic Isolator
Built for precision, flexibility, and the sterility demands of clinical and specialty programs.
Aseptic Handling
Fully closed robotic filling that eliminates human intervention at the critical fill point, across pre-filled syringe and cartridge formats.
01
Maximum Sterility Assurance
EU Annex 1 compliant with no open-air exposure at any stage, delivering the highest sterility assurance available for biologics and specialty programs.
02
Sensitive Formulation Handling
Cytotoxic and high-potency programs are manufactured in a dedicated, self-contained oncology suite, physically separated from all other drug product lines. RABS containment provides full operator and product protection through restricted access filling with Grade A environmental conditions.
03
Format Flexibility
As your program evolves across container formats, the same platform and the same team supports the transition without requalification or site changes.
04
Three Formats. One Facility.
Not all injectable programs require the same delivery format. Our team works with you to match the right format to your molecule's requirements, clinical stage, and patient administration needs.
Robotic aseptic filling for biologics, biosimilars, vaccines, and specialty injectables. Glass and plastic syringes in luer lock and staked needle formats, filled in a fully closed isolator environment.
Drug Substance Meets Container
Formulation Meets Container
Incoming QC release and cGMP-controlled compounding completed before filling begins, with preparation aligned to your product requirements and regulatory strategy.
Filling Under Closed Robotic Isolation
Nitrogen overlay and vacuum stoppering as standard. Headspace O2 below 5% achievable for oxygen-sensitive molecules. Viscosity handling from 1 to 40 cP.
Inspection and Release
Finished product QC testing and GMP batch release performed within the same facility as manufacture.
Packaging and Dispatch
Labelling, serialization, track-and-trace, secondary packaging, and ex-works dispatch within one GMP environment and one accountable team.
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Programs We Support
Clinical Trial Supply
Flexible batch sizes across Phase I through Phase III for pre-filled syringes, cartridges, and device combinations. Programs that begin clinical supply at BioCina progress to ongoing supply within the same facility and the same accountable team.
Small-Scale Commercial Manufacturing
For biologic and orphan drug programs requiring commercial-grade sterility assurance without large-scale batch minimums.
Did you know manufacturing in Australia could fund nearly half your program?
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Drug Product Manufacturing Track Record
0+ years
of Sterile Manufacturing Heritage
0M+ units
Annual Capacity
0+
Approved Products
0+
Countries Delivered
Ready to Start Your PFS or Cartridge Program?
Our team is ready to discuss your formulation, container format, and regulatory requirements, including programs exploring auto-injector integration.