Translate biopharmaceutical innovations from early development toward clinical manufacture

The UTS Biologics Innovation Facility (BIF) is an ISO 9001:2015-certified, GMP-like pilot biomanufacturing facility supporting researchers, start-ups and SMEs to translate biopharmaceutical innovations from early development toward clinical manufacture.

BIF provides cleanroom-based process development, pre-GMP pilot production, manual fill-finish and analytical testing using industry-aligned bioprocessing infrastructure and in-house QC capability.

Whether you are optimising a specific process step or planning a pilot-scale manufacturing campaign to support preparation for first-in-human development, BIF can help define a practical pathway aligned with your product, development stage and intended next step.

 

BIF

Capability highlights

  • GMP-like
  • ISO 9001:2015 certified
  • Industry-aligned bioprocessing
  • Phase I-enabling support
Your manufacturing pathway at BIF 1. Develop Define, test and optimise scalable, reproducible process and analytical methods using structured process development and risk-based approaches. 2. Pre-GMP manufacture Produce small- to pilot-scale biopharmaceutical material in a GMP-like environment, using industry-aligned upstream and downstream bioprocessing equipment, single-use technologies, advanced analytical QC, and fill-finish capability. 3. Prepare for GMP transfer Generate process, analytical and CMC-supporting data to streamline technology transfer for GMP manufacture, including Phase I-enabling material for selected projects.

Why access BIF’s manufacturing services?

  • Quality systems and cleanrooms

    Grade B-D cleanrooms and an ISO 9001:2015-certified quality management system for controlled, traceable GMP-like manufacturing.

  • Process development and scale-up

    Structured, QbD-informed process development and DoE to translate research-scale workflows into reproducible pilot processes.

  • Upstream, downstream and fill-finish

    Industry-aligned bioprocessing equipment, single-use technologies and manual fill-finish capability for flexible small-to-pilot scale production.

  • Analytical characterisation and QC

    In-house analytical capability for in-process testing, final product QC, product characterisation and process understanding.

  • Phase I-enabling support

    Manufacturability, stability and CMC-supporting data for selected products to assist GLP toxicology studies, stability studies and early clinical development planning.

  • Technology transfer readiness

    Development-stage data packages, technology transfer documentation and process handover to TGA-licensed CDMOs for full GMP manufacture.

BIF

Modalities supported

  • Monocloncal antibodies (mAbs)
  • Recombinant proteins
  • Extracellular vesicles
  • Nucleic acids
  • Biologically derived active pharmaceutical ingredients (APIs)
  • Cellular agriculture
BIF

Facility hire

Selected clients may access BIF cleanroom space, equipment and technical infrastructure for client-led process development or pilot manufacturing activities. Access is subject to project suitability, biosafety requirements and facility availability.

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BIF

Looking for subsidised access to BIF services?

BIF is NCRIS-affiliated infrastructure through Therapeutic Innovation Australia (TIA). Eligible researchers and SMEs may be able to access BIF services through the TIA Pipeline Accelerator voucher scheme, which provides matched funding to help eligible projects access specialist translational research infrastructure.

BIF can help shape your project scope, align the proposed work with BIF capabilities and support a voucher application for eligible manufacturing, process development or analytical services.

Contact us to discuss a voucher-supported project.

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Discuss your manufacturing project with BIF

Contact BIF to discuss your project scope, development stage and manufacturing requirements.

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