NCRIS Mammalian Biologics Facility
Our Biologics Production Facility is a catalyst for biotechnology research and innovation in Australia and supports Australian biosecurity and health.
Our facility is part of the National Collaborative Research Infrastructure Strategy program and enables us to:
- produce biologics in mammalian and insect cell cultures as well as purify them in a clean room – run under a Quality Management System and is ISO9001 and Veterinary cGMP certified
- support therapeutic discovery with optimisation, scale‑up, production and purification of recombinant protein drugs and vaccines in large quantities – from hundreds of milligrams to tens of grams
- manufacture proteins for conjugation for imaging and tissue targeting drugs.
CSIRO Biologics Facility (cGMP)
Launching early in 2022, a new multipurpose facility to produce a variety of biologics, including recombinant proteins and peptides and viral products for therapeutic applications in mammalian and insect cells. The facility will operate under cGMP regulations enabling production of biologics for clinical trials (Phase I and II).
The facility will enable process development and production of clinical-grade biologics (protein drugs and vaccines) to address an unmet demand in the Victorian and Australian Biotech landscape.
This new facility is designed and operated to be compliant with Australia’s Therapeutic Goods Administration (TGA), United States Federal Drug Administration (US FDA) and European Medicines Agency (EMA) regulations. This means that the Australian Biotech industry will have access to global clinical trial opportunities and a broader, faster path to market.
NCRIS Microbial Research and Development Facility
CSIRO’s Microbial Research and Development Facility is also part of the NCRIS program and offers process development and pilot-scale demonstration of processes used to manufacture microbial products with therapeutic applications.
The facility provides key infrastructure and skills enabling therapeutic products to transition toward commercial realisation. To support this the facility has:
- Multiple parallel bioreactors for rapid process development
- A high degree of flexibility to cater for many different microbial products and process configurations
- Pilot-scale process demonstration up to 400 litres
- Downstream processing suitable for different microbial products at both small- and pilot-scale.
With construction underway shortly, our purpose‑built Quality Control (QC) Laboratory will provide process testing services to support the manufacturing and release of biologics produced in the cGMP Biologics Facility and the NCRIS Mammalian Biologics Facility.
It will also provide local, accessible, and bespoke solutions for Australian companies and researchers engaging in early‑stage development of protein drugs and vaccines. Services include testing for: material quality, in process quality, end‑product quality release, stability testing, potency testing and development of bespoke potency assays and drug product stability testing.