Validating The Simoa Technology
Most of the advanced instruments used in bioanalysis—such as Gas Chromatography (GC), High Performance Liquid Chromatography (HPLC), and Liquid Chromatography-Mass Spectrometry (LC-MS) for example—are automated. Thus, they are controlled by complex computer systems, and the information they generate is stored electronically. If these systems are to be used in regulated research studies in the US, EU, and Japan, the instruments themselves must be qualified and their supporting software and processes must be validated as meeting regulatory requirements.
Bioanalytical Large Molecule
Gain access to comprehensive biologics services in support of advanced development programs with Frontage’s bioanalytical laboratory. We have the capabilities to analyze virtually any peptide, protein or antibody, and have built a reputation for solving technical challenges related to assay development and validation.
Bioanalytical Small Molecule
Frontage’s experienced staff and state-of-the-art instrumentation delivers data you can trust. Count on Frontage Laboratories for reliability. From method development or transfer and validation to sample analysis and reporting, Frontage’s bioanalytical team has earned a reputation for consistent and high-quality delivery, project after project. Our bioanalytical expertise extends to combined small and large molecules such as protein, antibody, antibody drug conjugates as well as biomarker analysis for small molecule drug candidates.
Gene Therapy 2019
Oligonucleotide (OGN) therapy is increasingly recognized as an important therapeutic modality on the promise of curing diseases. However, unlike most biotherapeutics, the development of OGN drugs often requires their determination with high sensitivity and specificity in multiple and complex biologic matrices such as blood and tissues in order to measure their exposure and distribution for understating PK, PD and safety.
At Frontage Laboratories, we have developed highly sensitive and specific quantitative methods for determination of OGN in plasma and tissues using hybridization immunoassay and LC-MS techniques. In this webinar, we will present the method development, validation and the comparison of these techniques for the quantification of OGN as well as a case study with antisense oligonucleotides.