by Dr. Kurt Sales, Chief Scientific Officer
Liquid chromatography-tandem mass spectrometry (LC-MS/MS) has been the preferred analytical method used in the pharmaceutical industry for fast, sensitive and quantitative bioanalysis of small molecule novel chemical entity drugs (NCEs) for a number of decades. Increasingly over the last 5-10 years it has also been used for the quantitative analysis of biopharmaceuticals, including peptides, proteins and more recently oligonucleotides.
Agilex Biolabs is Australia’s leading FDA-inspected bioanalytical laboratory with almost 30 years’ experience in LC-MS/MS bioanalysis. With a fleet of 17 Mass spectrometers, Agilex has the scale and expertise to cover a variety of different types of molecules from NCEs to sugars, enantiomers, peptides, oligonucleotides, and metabolites. Our scientists have an extensive in-depth experience in being able to solve the complex chemical problems associated with detecting the molecules in rare matrices, including ocular fluid and cerebrospinal fluid to support drug development programs in central nervous system projects, ophthalmology, hematology, oncology, infectious disease, dermatology, and gastroenterology.
What sets Agilex apart in the Australian bioanalytical ecosystem?
Scientific excellence, attention to detail and a customer-centric attitude is central to Agilex’s core values – attributes that are noticeable as early as the RFP and project quoting phase, where Agilex scientists use their in-depth knowledge to identify complexities associated with the molecule early on. This ensures that from the start, sample collection conditions, molecular instability and sample processing are considered to ensure that the project is scoped and costed correctly – ensuring no unwarranted surprises to the customer post award of the study. Our scientists are at the forefront of the latest chromatographic techniques and innovations ensuring we stay at the forefront of the constantly evolving field of bioanalysis.
What happens once the study has been awarded to Agilex?
Communication is key to success. From the start, the project is handed over to a dedicated project team, where the project is initiated. Dedicated method developers then start the iterative process of either transferring the method in or setting it up from scratch – ensuring all sample extraction conditions (either protein precipitation, liquid-liquid extraction or solid phase extraction or a combination) as well as chromatographic conditions are optimized to ensure the best separation and detection of analytes. All assays are tailored to the needs of the study ensuring rigor, robustness and a design that is fit-for-purpose. Before the assay is deployed on precious samples, it is either qualified or validated according to the ICH-M10 guidance for bioanalytical method validation, with quality control and quality assurance assessment at each stage. At Agilex, quality and integrity of the assay and sample analysis is paramount.
How fast can sample be analyzed to ensure continuous dosing in a SAD/MAD clinical study?
With a dedicated project management and sample handling team, samples are immediately booked into the Agilex sample handling and laboratory management system upon receipt. Samples are checked against the manifest and verified before being scheduled for analysis. This fast and streamlined process ensures a 3 day turn around for SAD cohorts and 4 day turnaround for MAD cohorts as a standard to facilitate fast dose escalation in the clinic – expediting the clinical trial.
From initiation to close-out the, Agilex team is available every step of the way to ensure success. With an 85% customer return rate and reputation for delivering difficult projects, Agilex has become the trusted partner for bioanalysis in Australia. To learn more about how Agilex can support your next project, contact us today for a confidential discussion.
