Avomeen’s bioanalytical laboratory is uniquely positioned to support challenging drug development projects, with an expert team and essential instrumentation. As an experienced bioanalytical CRO, Avomeen’s testing services provide a broad range of bioanalyses to support your clinical research. Importantly, biomarker validation and custom assay development are central components, tapping into our internal team’s expertise with biomarker research and its clinical applications. Avomeen also complements this skillset with a complete offering of DMPK/ADME services and toxicity assessments. Whether you need help designing and developing, or simply need a trusted team to collect and analyze data, you’ve come to the right place.
Avomeen’s Bioanalytical Testing Services
Bioanalysis & Clinical Biomarker Services – Avomeen’s expert scientists can validate and improve existing methods or develop custom ones. We can also take these methods and use them to perform sample analysis, including quantitative analysis of biomarkers and drugs, applying leading knowledge of a diverse suite of biomarkers and multiple assay platforms.
DMPK & ADME Support – Understanding how a drug behaves in a living system is critical for preclinical and clinical research as well as overall safety and efficacy. We offer advanced bioanalysis of a drug’s metabolic and pharmacokinetic profile including established and custom ADME assays and therapeutic drug monitoring. We can then use our method development and data collection abilities to fully support IND filing.
Toxicity & Clearance Assays – Complementing ADME investigations, clinical researchers need clear data on a drug’s toxicity. Avomeen is adept at performing in vitro cytotoxicity assays to ISO-10993-5 standards and analyzing samples from preclinical toxicology studies. Together, we can help you determine dosing and reduce the risk of failure in later clinical trial phases. These residual and clearance assay skills can also be applied more broadly to support both drug and food safety.
Avomeen’s Bioanalytical Laboratory Capabilities
We work with our partners to determine what assays, methods, and platforms will best help them answer critical questions and solve outstanding problems they are facing. To accomplish this, Avomeen’s bioanalytical laboratory utilizes the following advanced tools:
- Capillary Electrophoresis (CE, Protein Simple Maurice)
- Thermo Scientific Vanquish LC – QExactive+ System
- Ultra-Performance Liquid Chromatography (UPLC, Agilent) with ELSD, UV-DAD and FLD and Connected to TQD and QToF Mass Spectrometers
- High-Performance Liquid Chromatography (HPLC, Agilent) with UV-DAD, ELSD GCs with FID, MSD and TQD Detectors
- AB Sciex Triple Quadrupole API 2000 and 3000 Mass Spectrometers
- Dionex ICS-3000 Ion Chromatography System
- Agilent 7800 LC-ICP-MS system
- Mammalian Cell Culture Facility
- Droplet Digital PCR (dd-PCR)
- Cell Counter
- Micro-Plate Reader
Why Partner With Avomeen for Your Biomarker and Bioanalytical Testing?
As the sophistication of biomedicine marches forward, so too do the demands and complexities of translational and clinical research. As we progress deeper into this new of age of medicine, revolutionary biologic therapies, personalized medicine, and other major advancements require more refined and thorough bioanalytics to evaluate efficacy and ensure patient safety. In particular, the growth of biomarker research opens up opportunities to track drug function more directly through its mechanism of action.
The Role of Biomarkers in Drug Development
Collectively, this allows clinical research teams and regulators to make more informed decisions and increase the efficiency of the entire process. However, the knowledge required to adeptly execute on the potential of bioanalytics is often overwhelming and not easily acquired. This is especially true given the ever-expanding list of relevant biomarkers across a range of biomolecular classes, as well as the many analytical platforms needed for biomarker analysis. Put simply, pharmaceutical companies and drug developers have their work cut out for them.
With Avomeen’s bioanalytical laboratory, our partners benefit from short lead times and superior turnaround compared to other bioanalytical CROs. Depending on the complexity of the request, we can complete the work in as little as 5-20 business days – not months, as commonly occurs elsewhere. This speed provides a competitive edge but does not sacrifice the highest standards of quality. Our team has a deep familiarity with regulatory guidelines (including FDA, EMEA, ISO, GLP, and GMP) and SOPs, recognizing the mission critical nature of regulatory adherence.
No problem is too complex. We can maximize study ROI with high integrity data, even when working with small sample volumes. So, let’s talk about your research and how our bioanalytical testing services can make a difference.