Case Studies

Focused team meeting at Alderley Analytical: A close-up view of team members deeply engaged in a strategic discussion. The central figure, animatedly explaining a concept, captures the collaborative spirit and commitment to excellence that define the team's approach to solving complex analytical challenges
This image features a scientist working in a sophisticated laboratory setting, surrounded by advanced analytical equipment. The scientist, dressed in a white lab coat, safety glasses, and purple gloves, is seated in front of a chromatography system, a crucial tool in the separation, identification, and quantification of chemical components. He appears to be adjusting settings or analyzing data on a computer connected to the chromatography equipment, indicating the integration of technology and science in modern analytical methods. The laboratory is equipped with various high-tech instruments, suggesting a focus on precision and efficiency in analytical testing. This environment highlights the complexity of bioanalytical research and the importance of cutting-edge technology in obtaining accurate and reliable results. This scene underscores Alderley Analytical's commitment to utilizing advanced technologies and methodologies to meet the demands of bioanalytical testing. It reflects the company's emphasis on quality, innovation, and expertise in the field, showcasing their capability to handle complex analytical challenges with precision and professionalism.
In the heart of Alderley Analytical's laboratory, a scientist meticulously conducts experiments within a safety cabinet, fully adorned in protective gear including a face shield and gown. This image underscores the rigorous safety standards and attention to detail that are paramount in the company's operations, ensuring both the safety of its personnel and the integrity of its analytical processes.

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.

A meticulous scientist at Alderley Analytical is seen handling vials for analysis in a state-of-the-art automated laboratory equipment. Wearing protective gloves and a lab coat, the focus and precision in their work underscore the high standards of safety and accuracy upheld in the lab. This image reflects the company's commitment to delivering reliable and cutting-edge bioanalytical services.
The image provides a view inside a modern, well-equipped laboratory, showing two scientists at work. Both are dressed in white lab coats and safety glasses, emphasizing the importance of safety and professionalism in the lab. The scientist in the foreground, wearing blue gloves, is focused on pipetting a sample, a task requiring precision and concentration. Various lab equipment and documents are spread out on the workbench, indicating an active research environment. In the background, another scientist is also engaged in meticulous work, underlining the collaborative and diligent atmosphere within the laboratory. The array of computers and scientific instruments suggests a high-tech environment equipped for detailed analysis and research. This setting exemplifies the rigorous, detail-oriented work conducted at Alderley Analytical, highlighting the company's commitment to scientific excellence and accuracy in bioanalytical testing. The image successfully conveys a sense of the advanced technological capabilities and the professional expertise that Alderley Analytical offers to its clients, aligning with the company's emphasis on quality, reliability, and innovation in their field.

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 – or PK data from the clinical studies, enabling the rapid and successful progression of the programme.

A dedicated Alderley Analytical scientist meticulously conducts pipetting operations as part of a comprehensive analysis process. Equipped with a lab coat, safety glasses, and a face mask, the researcher's attention to detail exemplifies the rigorous standards of precision and care upheld in their cutting-edge laboratory environment. This scene captures the essence of Alderley Analytical's commitment to delivering high-quality, reliable bioanalytical testing services.
A focused scientist at Alderley Analytical works on a high-tech liquid chromatography-mass spectrometry (LC-MS) system, showcasing the advanced analytical capabilities of the lab. The researcher, viewed from behind, manages sophisticated instrumentation connected to a computer displaying operational software. This scene highlights the lab's commitment to utilizing state-of-the-art technology for precise and accurate bioanalytical studies, ensuring top-quality results for their clients.

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 Cerebrospinal 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.

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