Non-Regulatory Bioanalysis

Close-up view of an advanced multi-channel pipette dispensing samples into a microtiter plate at Alderley Analytical. The image highlights the precision and efficiency of modern laboratory equipment in facilitating high-throughput screening and analysis. The focus on the pipette tips against a blurred laboratory background underscores the meticulous attention to detail and technological sophistication that underpin the analytical services provided by Alderley Analytical.
A detailed perspective of a laboratory technician’s hand, clad in a blue glove, expertly using a Rainin multi-channel pipette to transfer liquid samples into a well plate. This image captures the essence of precision and care in sample preparation, showcasing the critical initial steps in bioanalytical processes at Alderley Analytical. The focus on the action and the blurred background emphasize the concentration and meticulousness required in the lab environment.

When you need to make pivotal decisions about progressing lead candidates from discovery PK and efficacy studies as part of the Design, Make, Test and Analyse (DMTA) cycle, no-one knows better than us how much time is of the essence. It’s vital to ensure rapid turnaround of results to measure drug concentrations in the biological samples collected.

At Alderley Analytical, we offer a non-regulatory bioanalysis service to support your early studies. Our discovery assay approach via UPLC-MS/MS can quickly analyse samples for compound concentrations and with results provided in as little as 3 working days after receipt of samples, helping you to rapidly discover and progress the best drug candidates. We can also calculate any required pharmacokinetic (PK) analysis on your data.

For large molecule biotherapeutics, early development can also be supported via discovery stage PK assays and pharmacodynamic marker (PD) and exploratory biomarker analysis.

We offer 2 levels of
non-regulatory bioanalysis

Level 1

This is a rapid screen where costs are minimal. We set up the UPLC-MS/MS for your molecule and use a generic methodology that we have developed to quickly get results generated for your understanding of the PK or exposure of your molecule.

Level 2

Typically this approach is used for when you need additional testing of your assay for a tighter data set, usually during dose range finding studies where the data will be used to set dose levels in pivotal studies, or just when you need a higher standard of data compared to the Level 1 approach. We set up the UPLC-MS/MS or ELISA (using MSD or Colorimetric endpoints) for your molecule and tailor the method for your molecule. We can also run a small validation called a qualification (limited validation) so you can understand the accuracy and precision of the assay for your molecule.

Similarly, for biotherapeutics, including both PK and biomarker assays, the methods applied can be tailored to their ‘context of use’, i.e. the intended use of the data within the development programme of the drug.

The image showcases a close-up view of a scientist's hand, gloved in blue, carefully placing or retrieving a vial into a centrifuge. The centrifuge appears to be a high-precision laboratory equipment, used for separating substances based on density by spinning them at high speed. The scientist is wearing a white lab coat, indicating a professional laboratory setting. This scene captures a moment of meticulous laboratory work, emphasizing the expertise and precision in bioanalysis. It highglights the company's focus on high-quality, precise analytical services in the field of bioanalysis.
A focused Alderley Analytical technician, wearing a lab coat, face mask, and blue gloves, is intently observing the readings on a portable digital device during an experiment. This moment highlights the integration of advanced technology and meticulous attention to detail in the laboratory’s daily operations, ensuring accuracy and reliability in their analytical processes.

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