An assay validation study can help you make important decisions to protect the integrity of your trial. You can choose three levels of service that we provide to optimize and validate your assay:
– Proof-of-concept (POC) to verify the feasibility of reagents.
– Quantification to test the validity of biomarkers by using
– method-to-method comparing studies.
– Full-validation to validate assay through standard tests to be applicable, and to support GCP and GLP studies. The validation includes intra- and inter- precision, tech-to-tech comparison, sample stability, sample recovery, linearity etc.
Assay validation studies are focused on assay performance. The validated assay is to ensure that the tested biomarker is linked to a clinical significance to support your Investigative New Drug Application (INDA) and New Drug Application (NDA).
Alera Labs specializes in Method and Assay Development, offering valuable services to a wide range of industries. Method and Assay Development involves the design, optimization, and validation of analytical methods and assays to analyze various substances and compounds. This service is crucial for industries such as pharmaceuticals, biotechnology, agbio, medical devices, cosmetics, chemicals, and food.
When searching for information about Method and Assay Development, relevant keywords include “analytical method development,” “assay optimization,” “method validation,” “chromatographic analysis,” “HPLC method development,” “GC method development,” “LC-MS method development,” “LC-MS/MS method development,” and “analytical method optimization.”
Alera Labs utilizes cutting-edge techniques including HPLC (High-Performance Liquid Chromatography), GC-MS (Gas Chromatography-Mass Spectrometry), LC-MS (Liquid Chromatography-Mass Spectrometry), and LC-MS/MS (Liquid Chromatography with tandem Mass Spectrometry) for Method and Assay Development across diverse industries.
These techniques enable the development of robust and sensitive methods for the analysis of various substances, including small molecules, drugs, biomarkers, impurities, and complex mixtures. HPLC and GC-MS are commonly used for separation and quantification, while LC-MS and LC-MS/MS provide enhanced sensitivity, selectivity, and structural elucidation capabilities.
Method and Assay Development services offered by Alera Labs encompass method design, optimization, and validation for diverse applications such as purity testing, impurity profiling, quantitative analysis, stability testing, and identification of unknown compounds.
These services play a crucial role in ensuring accurate and reliable analytical results, facilitating quality control, research and development, regulatory compliance, and overall product quality for the industries Alera Labs serves.
Alera Labs’ expertise in Method and Assay Development, coupled with the use of advanced techniques like HPLC, GC-MS, LC-MS, and LC-MS/MS, allows for the efficient and precise analysis of substances, supporting the needs of clients across various industries. The aim is to provide tailored and optimized methods that meet specific analytical requirements, contributing to advancements in healthcare, agriculture, manufacturing, and scientific research.