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Large molecule pharmacokinetics assay

A key to better understanding the safety and effectiveness of a new therapeutic in humans is to consider its Absorption, Distribution, Metabolism and Excretion (ADME) and pharmacokinetic (PK) properties. PK studies result in the measurement of drug concentration in specific body compartments and help to understand the consequence of systemic exposure to the drug. PK results can then be compared to the pharmacodynamic (PD) results to understand the correlation between the concentration of a compound and the effect that the drug is causing.

Large molecules – also known as biologicals, biologics, or biopharmaceuticals – can be monoclonal or bispecific antibodies or recombinant proteins. At Crux Biolabs, large molecule PK samples are mainly investigated using a plate-based approach on one of the multiple plate readers capable of measuring absorbance, luminescence, fluorescence, or electroluminescence. Crux Biolabs has been developing absorbance-based assays for more than 10 years and has recently focused on offering electroluminescence on the MSD platform. This allows the analysis to reach new levels of sensitivity and help resolve complex matrix interference.

Crux Biolabs believe in strong scientific collaboration with clients. The choice, advantages and disadvantages of each platform will be discussed during the first client interaction.  Method development will be performed by keeping in mind sponsor requirements, in terms of range, sensitivity and the requirements of the main regulatory bodies, such as the FDA, ICH or EMEA.

A full validation report will be issued before commencing clinical testing and includes accuracy and precision, selectivity, specificity (if required), and stability parameters – delivering confidence and knowledge of the parameters of the assay.

Crux Biolabs then proceeds to clinical sample testing and performance monitoring of the assay throughout the life of the study. We use robust system suitability and incurred sample reanalysis to achieve confidence in generated results.

Crux Biolabs has a strong understanding of the requirements of clinical trials performed in Australia and their associated timelines. We develop validated assays in accelerated timeframes and return patient-related results within 5 days as standard.

All aspects of a large molecule PK assay were recently audited by Australia’s leading accreditation body – NATA. This included training, method development, validation, sample management, sample testing and reporting. Overall, this led to the addition of large molecule PK to Crux Biolab’s scope of accreditation.