Lambda Therapeutic Research is a global full-service CRO offering an extensive range of bioanalytical capabilities, specializing in cell-based assays, biomarkers, immunogenicity, and pharmacokinetics (PK). Backed by state-of-the-art facilities and a team of experienced scientists, Lambda provides comprehensive solutions for the analysis of small molecules, biomarkers, biologics, and therapeutic elemental drugs.
Various intravenous iron preparation used widely to treat anaemia. For precise Iron measurement, one of the powerful analytical techniques is inductively coupled plasma mass spectrometry (ICP-MS). With its high sensitivity and wide dynamic range, ICP-MS enables the precise measurement of single/multiple elements at trace levels in biological fluids simultaneously.
Meeting the Complexities of Elemental Analysis for Iron Preparations
- Elemental analysis poses unique challenges when it comes to selecting the appropriate matrix, such as separation of iron components, endogenous levels in the matrix, and the requirement for a low limit of quantification (LLOQ).
- Our commitment to innovation has led us to develop new methods on the ICP-MS instrument, which offers enhanced specificity and sensitivity, with a similar element used as an internal standard.
- To ensure consistency across calibration curve standards, quality control samples, and study samples, we have chosen an authentic serum matrix. Our stringent approach includes blank matrix iron interference subtraction from the calibration curve standards for accurate linear calibration curve and 1/X2 regression calculations.
- Additionally, we prepare additional quality control samples at various concentration levels using the formulation to mirror the study samples and ensure precise measurements.
Expertise in Iron Preparations: A Proven Track Record
- Lambda brings extensive expertise and a proven track record in the analysis of iron preparations on in-vitro diagnostic instruments. Our vast experience in this field enables us to navigate the complexities of clinical trials with ease.
- Our successful submission of completed studies to the USFDA and EMA has solidified our reputation as a trusted partner in achieving marketing authorizations for iron preparations.
- Leveraging our extensive experience, we have conducted bioequivalence studies on various iron preparations, showcasing our competence in executing clinical trials.
- Over the years, we have refined our methodologies and adapted cutting-edge technologies including ICP-MS methods, staying at the forefront of advancements in the field.
- Additionally, the ICP-MS Qtegra software, with its audit trail and compliance with 21CFR Part 11, provides a robust framework for ensuring data integrity and regulatory compliance.
Extensive Experience:
Lambda has accumulated extensive ICP-MS expertise in method development, validation, sample preparation and quantitative analysis of elements.
| Formulation | Analyte | Matrix | Assay Status | Study Experience |
|---|---|---|---|---|
| Iron Sucrose | Total Iron | Human Serum | Validated Assay | 2 Studies Completed |
| Transferrin Bound Iron | Human Serum | Validated Assay | ||
| Ferumoxytol | Total Iron | Human Serum | Developed & Ready for Validation | 1 Study Completed |
| Transferrin Bound Iron | Human Serum | Developed & Ready for Validation | ||
| Ferric Carboxy Maltose | Total Iron | Human Serum | Validated Soon | – |
| Transferrin Bound Iron | Human Serum | Validated Soon | ||
| Potassium Chloride / Potassium Citrate | Potassium | Human Urine | Developed & Ready for Validation | – |
| Lithium Carbonate | Lithium | Human Plasma | Upcoming Development | – |
| Bismuth | Bismuth | Human Plasma | Upcoming Development | – |
Partner with Lambda to expedite your study timelines, navigate regulatory challenges, and achieve faster marketing authorizations.Get in touch with our team of experts.
