Sterile Vial Filling
for Biologics and Small Molecules
Precision aseptic filling in vials for injectable drug products at clinical and commercial scale. Different validated filling environments matched to your molecule, your format, and your regulatory strategy.
Multi-format vial filling
We fill vials from small-volume hand fills through to commercial-scale batches, supporting every stage of your program without compromise.
Aseptic Handling
Grade A filling zone conditions maintained throughout aseptic operations, with continuous environmental monitoring and in-process controls at every stage of manufacture.
01
Integrated QC
and Inspection
In-process controls including fill weight verification, visual inspection, particulate detection, and continuous environmental monitoring ensure every unit meets exacting quality standards before packaging and release.
02
High-Potency Capable
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
Vial Formats from
Clinical to Commercial
From early clinical supply through to millions of units annually, every program scales without compromise on quality, precision, or regulatory confidence.
04
Three Environments. One Decision.
Not all sterile vials require the same manufacturing approach. Our formulation and manufacturing teams assess each product and recommend the right environment based on your molecule's heat stability, potency, batch size, and regulatory strategy.
The globally preferred method for heat-stable sterile injectables. Product is filled and then sterilized by heat after filling, providing an additional sterility assurance layer for hospital generics, diagnostic solutions, and other applicable injectable formats.
From Formulation to Distribution
Compounding
Raw material receipt, incoming QC release, and cGMP-controlled compounding, with preparation aligned to your selected filling environment before manufacturing begins.
Aseptic Filling
GMP fill-finish executed in the validated environment matched to your molecule, with continuous environmental monitoring and in-process controls throughout.
Inspection
Manual visual inspection and particulate detection to exacting standards before packaging and quality release.
Batch Release
and Dispatch
Finished product QC testing, GMP batch release, labelling, and secondary packaging completed within one GMP environment. Products prepared for ex-works dispatch.
View Technical Specifications
Programs We Support
Biologic Injectables
Aseptic vial fill-finish for recombinant proteins and biosimilars requiring maximum sterility assurance in a fully closed robotic isolator environment.
Cytotoxic and Oncology Injectables
High-potency and cytotoxic injectables filled under RABS containment with Grade A filling conditions, protecting both product integrity and operator safety.
Sterile Hospital Generics
Terminally sterilised injectable liquids for hospital supply and generic pharmaceutical programs.
Oxygen-Sensitive Injectables
Specialty molecules requiring nitrogen overlay and headspace oxygen control below 5%, filled in a fully closed isolator environment.
Clinical Trial Supply Aseptic vial fill-finis
Clinical Trial Supply
Aseptic vial fill-finish from Phase I through commercial scale, including small-batch orphan drug manufacturing.
Did you know manufacturing in Australia could fund nearly half your program?
Learn More
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 Sterile Vial Program?
Our team is ready to understand your formulation, timeline, and regulatory requirements and find the right path forward.