Process Development & Manufacturing

We have extensive experience of assisting clients in translating their science and novel therapeutic targets to support clinical end points.

Phase Appropriate Manufacture

We have extensive experience (>15 years) of assisting clients in translating their science and novel therapeutic targets to support clinical end points.

The NBF recognises that an appropriate quality system that governs activities which may bridge early stage biotherapeutics development and clinical manufacture is a valuable attribute which underpins the development of high-quality biopharmaceuticals.

Our phase-appropriate approach to protein manufacturing ensures that quality is embedded from the outset rather than retrospectively applied. NBF's ISO 9001 certified quality management system provides the framework for controlled documentation, risk assessment, and change management across all stages of biologics development, helping clients avoid costly rework as programs advance towards clinical manufacturing and regulatory submission.

Bioprocess operation in the manufacturing suite

Process Development and Scale Up

As programs move from development to the clinic, it is imperative to establish a data package around each of the upstream, downstream, and supporting analytical testing needs to reproducibly manufacture the protein of interest.

NBF's process development scientists work systematically to define critical process parameters and establish proven acceptable ranges at each step of recombinant protein production. This data-driven approach to scale-up, from bench-scale optimisation through to 50L bioreactor operation, ensures that the manufacturing process delivers consistent drug substance quality. Our integrated upstream and downstream development capability means that purification strategies are co-developed alongside cell culture conditions, reducing the overall timeline for therapeutic development programs.

Cleanroom bioreactor manufacturing

Single-Use Systems

Single-use product contact surfaces helps mitigate the risk of cross contamination and to drive efficiencies within NBF operations. A range of process scales is available with single-use options from bench to 50 L bioreactor.

Single-use technology options are available across much of NBF's bioprocessing workflow, including cultivation vessels, bioreactors and filtration assemblies. This commitment to disposable product contact surfaces eliminates cleaning validation requirements between manufacturing campaigns and significantly reduces turnaround times, making it particularly advantageous for the multi-product biopharmaceutical environment in which NBF operates. The approach also lowers the barrier to entry for academic and small biotech clients pursuing early-stage biologics development.

Researcher monitoring bioreactor

Upstream Process Development

Upstream development focuses on optimising the process with clinical manufacturing in mind, utilising small-scale technologies through to a single-use 50 L bioreactor.

NBF's upstream bioprocessing capabilities encompass media and feed optimisation, cell culture parameter screening, and fed-batch or perfusion strategy evaluation. By leveraging Design of Experiments (DoE) methodologies in small-scale bioreactor models, our team can rapidly identify the optimal conditions for maximising recombinant protein production titre and product quality. This systematic approach to upstream process development ensures a robust and scalable manufacturing process that supports the transition from laboratory-scale protein manufacturing to clinical-grade drug substance production.

Chromatography purification system

Purification Development

The NBF customises downstream process development using industry-relevant technologies to ensure the end product is stable, fit for purpose and meets your target purity profile requirements. We support everything from research-enabling protein preparations to gram-scale outputs suitable for Phase I clinical use.

Our purification platform includes affinity chromatography, ion exchange, size exclusion, and mixed-mode chromatography steps, selected and optimised to achieve the purity and yield targets demanded by each biopharmaceutical program. NBF scientists develop scalable purification processes with protein characterisation data integrated at every stage, ensuring that host cell protein, residual DNA, and aggregate levels meet the stringent specifications required for clinical-grade drug substance. This downstream expertise, combined with formulation development and fill capabilities, provides a complete pathway from harvest to final product.

Researcher operating a chromatography purification system

Frequently Asked Questions

Upstream bioprocessing refers to the cell culture and fermentation steps that produce the target protein, including cell line expansion, media optimisation, and bioreactor cultivation. Downstream bioprocessing encompasses all steps required to purify the protein from the cell culture harvest, including chromatography, filtration, and formulation. NBF provides end-to-end process development covering both upstream and downstream operations.
NBF can manufacture recombinant proteins from bench-scale shake flasks through to 50-litre single-use bioreactors, and multiple 50L runs can be pooled as a single batch if required. This range supports early-stage research material (milligram quantities) through to gram-scale production suitable for preclinical studies and Phase I clinical trials. Our single-use systems minimise cross-contamination risk and enable efficient changeover between projects.
Single-use bioreactors are disposable cultivation vessels with pre-sterilised, pre-validated product contact surfaces. They eliminate the need for cleaning validation between batches, reduce cross-contamination risk, and increase operational efficiency. NBF uses single-use systems across our process development and manufacturing operations, from small-scale development vessels through to our 50L production bioreactors.
NBF follows an established scale-up pathway that begins with small-scale process development to define optimal culture conditions, media composition, and harvest timing. Once the process is characterised, we transfer it to larger bioreactors using our validated platform, ensuring consistent product quality at each scale. This data package forms the basis for regulatory submissions supporting clinical trial applications.

NBF is proudly supported by

NCRIS Therapeutic Innovation Australia The University of Queensland