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Dedication to delivery: Rapid analysis to ensure premature baby safety

The challenge

Our client asked us to help with a clinical study in premature babies dosed with a biopharmaceutical formulation. The brief was to provide sample results within six hours of dosing, whatever time of day or night that occurred. Of course, the very nature of premature babies is that their arrival is unpredictable and we were therefore given very short notice of when doses had been administered.

Our solution

We set up a 24/7 rota of carefully trained staff and ensured effective communication between the clinic, couriers and the lab. This ensured that the whole team were promptly notified as soon as a new baby was recruited and a dose was administered, and information on sampling regimens and delivery schedules was shared.

Benefit for our client

Alderley Analytical’s dedication, effective communication and responsiveness ensured that the clinic had the right information within the six hour window to enable them to adjust the dose appropriately, giving each premature baby the best chance of survival. We call that a good day at the office.

Nothing elementary about this challenge: Low level measurement of aluminium in human plasma

The challenge

Our client wanted to dose a formulation that contained aluminium to human volunteers, which meant an assay to measure aluminium in human plasma with a Lower Limit of Quantification (LLOQ) of 5 ng/mL was required. This really was a challenge! Aluminium is naturally present in plasma, in the laboratory environment and many general laboratory consumables including water, vials, pipette tips, solvents and instrumentation. This meant the results were susceptible to error, therefore absolute control on contamination was required. Other CROs did not want to take on this task or had already tried and failed to validate a suitable assay, which is where Alderley Analytical stepped in to help.

Our solution

We diligently scrutinised every stage of the assay and modified it wherever possible to reduce any background levels of aluminium. This started with sourcing speciality, low level aluminium consumables and solvents. We also identified that Inductively Coupled Plasma Mass Spectrometry (ICP-MS) would be the most suitable instrument for this challenge.

Benefit for our client

Our careful choice of instruments, techniques and consumables enabled us to successfully develop and fully validate the assay. We obtained the challenging LLOQ of 5 ng/mL and ensured the generation of high quality Pharmacokinetic data from the clinical studies, enabling the rapid and successful progression of the programme.

A stability balancing act: Multi-analyte, multi-matrix stability issues

The challenge

Our client wanted to measure a drug and 3 metabolites from a clinical trial in human plasma and Cerebral Spinal Fluid (CSF). The drug and metabolites had different stability profiles needing various stabilisers in the different matrices.

Our solution

Recognising the importance of generating high quality data for the trial, we advised that it was important to investigate the stability of the drug and metabolites well before the start of the study.

We carried out extensive stability evaluations in human blood, plasma and CSF and looked at different storage temperatures, stabilisers and stabiliser concentrations. Following these evaluations an optimal stabiliser, stabiliser concentration and storage conditions were identified.

The optimal storage conditions were communicated to the clinics and the chosen stabilisers were added to the vacutainer at Alderley Analytical and shipped to the clinics prior to sampling.

Benefit for our client

Our work ensured that all the clinical samples were stabilised at the point of sampling, thus protecting their integrity and resulting in high quality PK data being generated from the study.