Bioanalytics & Characterisation

The NBF has state-of-the-art laboratory analysis equipment, coupled with proven analytical method development expertise to build the data package assessing protein quantity, purity, quality, and stability.

Analytical Expertise

The NBF has state-of-the-art laboratory analysis equipment, coupled with proven analytical method development expertise to build the data package assessing protein quantity, purity, quality, and stability.

Our bioanalytics team at the Australian Institute for Bioengineering and Nanotechnology (AIBN) applies a comprehensive suite of orthogonal analytical methods to deliver thorough protein characterisation for every stage of biologics development. From early-stage recombinant protein production through to clinical-grade drug substance release, NBF provides the critical quality data needed to support regulatory submissions. Techniques including SE-UPLC, CE-SDS, surface plasmon resonance (SPR), and DLS enable detailed assessment of size variants, charge heterogeneity, binding kinetics, and aggregation profiles. All analytical work is performed under our ISO 9001 quality management system, with documented methods and traceable results that meet the expectations of biopharmaceutical regulatory authorities.

Protein analysis under UV illumination

Formulation Screening

The NBF has advanced formulation screening equipment to accelerate the formulation development process. Coupled with proven analytical expertise this ensures that your protein remains stable and effective.

Our integrated approach supports efficient identification of optimal formulations tailored to your product’s specific requirements, ensuring protein therapeutics remain stable, potent, and fit for purpose.

Formulation is a critical yet often underestimated component of successful protein manufacturing and therapeutic development. NBF utilises high-throughput thermal stability screening, dynamic light scattering, and accelerated stability studies to evaluate buffer composition, pH, excipient selection, and protein concentration effects on product stability. This data-driven formulation development approach reduces the risk of degradation, aggregation, and loss of biological activity during storage and transport, ensuring that the final drug substance meets the quality specifications required for clinical use. Our formulation capabilities integrate seamlessly with NBF’s upstream and downstream bioprocessing services, providing a complete end-to-end pathway for recombinant protein production and characterisation.

Pipette tips in microplate well

Analytical Testing Capabilities

Comprehensive suite of analytical methods for biologics characterisation, release testing, and stability monitoring.

Analysis CategoryAssays & Methods
Quantitation
Absorbance at 280 nmSlope spectrometrySurface plasmon resonance (SPR)Analytical Protein A titer
Purity
Size-exclusion UPLCMass PhotometryCE-SDSSDS-PAGE
Appearance
Colour & clarityParticulates (visual & sub-visual)Osmolality & pH
Identity
SDS-PAGEWestern blotCE-SDSPeptide mass fingerprinting*Binding kinetics by SPR
Product Purity & Impurity
Aggregation profile (CE-SDS, SE-UPLC)Charge variants (cIEF or CEX)Fragmentation (SDS-PAGE, rp-HPLC)Size variants (reducing & non-reducing CE-SDS)
Process-related Impurities
qPCR & kit-based residual testingResidual DNAHost cell protein (HCP)Protein A
Activity / Potency
Colorimetric, kinetic & enzymatic assaysBinding ELISA & ligand interactions (SPR)
Safety
EndotoxinBioburden*Sterility*
* Outsourced assays

Frequently Asked Questions

NBF employs a comprehensive suite of analytical techniques including size-exclusion chromatography (SE-UPLC), capillary electrophoresis (CE-SDS), mass photometry, surface plasmon resonance (SPR), SDS-PAGE, and Western blotting. These methods assess protein quantity, purity, identity, stability, and biological activity to build a complete characterisation data package for your biologic product.
SEC-MALS (Size-Exclusion Chromatography with Multi-Angle Light Scattering) is an analytical technique that separates proteins by size and measures their absolute molecular weight. It is critical for biologics because it detects protein aggregation, a key quality attribute that affects both safety and efficacy. NBF uses SE-UPLC and complementary techniques like mass photometry to thoroughly assess aggregation profiles.
Protein purity is assessed using multiple orthogonal methods including SE-UPLC for size variants, CE-SDS for molecular weight analysis under reducing and non-reducing conditions, SDS-PAGE, and charge variant analysis by cIEF or CEX chromatography. We also test for process-related impurities such as host cell proteins (HCP), residual DNA, and residual Protein A to ensure the product meets clinical-grade specifications.
A certificate of analysis (CoA) is a document issued with each batch of manufactured biologic product, summarising the results of all quality control tests performed. It typically includes results for identity, purity, potency, safety (endotoxin, bioburden, sterility), and appearance. NBF provides CoAs for products manufactured under our ISO 9001-certified quality management system, supporting regulatory submissions for clinical trials.

NBF is proudly supported by

NCRIS Therapeutic Innovation Australia The University of Queensland