What is Bioanalysis?
Bioanalysis is a specialized branch of analytical chemistry that aims to quantify the concentration of a drug, metabolite, or biomarker in a biological matrix such as blood, serum, plasma, urine, or tissue samples.
When are Bioanalytical studies needed in drug development?
Bioanalytical studies are critical in any drug discovery and development program. Studies that require bioanalytical support include bioavailability (BA)/bioequivalence (BE), non-clinical pharmacokinetics (PK)/toxicokinetics (TK), anti-drug antibody assays (ADA), and biomarker evaluation. Guidelines for these studies have been outlined by the FDA, ICH, EMA, and other global regulatory bodies.
How can Emery Pharma help with your Discovery and Development programs?
Reliable bioanalytical assays require robust method development and validation. At Emery Pharma, we utilize sophisticated techniques to help our Clients’ with their bioanalysis needs in support of all stages of drug discovery and development programs.
Small molecules: we specialize in LC-MS/MS method development and validation, including multi-component analysis, pro-drugs, metabolites, photo-, and temperature-sensitive compounds.
Biologics: we provide ELISA, anti-drug antibody assays (ADA), immunogenicity, neutralizing antibody assays (NAb), multiplexed ligand binding assays (e.g., MSD), LC-MS/MS, and immunoaffinity-based LC-MS assays.
Stage of development: we support programs across discovery, pre-clinical studies, clinical trials (Phase I, II, and III), and regulatory submissions across the globe.
Services offered: Services include study design, de novo bioanalytical method development, sample cleanup/preparation, qualification, GLP-level validation, and sample analysis.
What are the Challenges in Bioanalysis?
For many scientists, bioanalytical method development, validation, and reporting may seem like a ‘black box’ – as it necessitates an intuitive understanding of how analytes behave in an ever-evolving complex biological matrix.
Utilizing a customized approach, our team has the experience to face every challenge that comes our way. We are perfectly suited to handle all of the following challenging aspects about Bioanalysis.
- Requirement for robust methods that work with many different sample types and background matrices, such as blood/plasma/serum, various tissues, and samples from both pre-clinical and clinical setting.
- Processing samples derived from unknown genetic, metabolic, and dietary makeup, which pose unpredictability during analysis.
- Employing sophisticated instrumentation such as triple quadrupole mass spectrometers that require specialized training.
- Submissions with phase-appropriately validated methods that adhere to GLP guidelines described in 21CFR58, Good Laboratory Practice for Nonclinical Laboratory Studies.
- Familiarity with Regional differences in guidance and acceptance standards for various regulatory bodies (FDA in the United States, EMA in Europe, ANVISA in Brazil, etc.) that are updated regularly. (a draft ICH M10 guidance on Bioanalysis is yet to be ratified)
We are happy to be the partnering lab for Clients requiring analysis for such hard-to-solve problems by sharing our extensive technical knowledge and experience. Please contact us today to learn more about our services and let us know how we can be your bridge to success on your next bioanalysis project.