Accurant Biotech is a full-service CRO with sites in the US and China. We provide GLP bioanalysis, CMC testing, clinical trial and regulatory affair support.
Our CMC services guarantee product quality, stability, and regulatory compliance. Our expertise covers General and Compendial Testing, Impurities, Potency, Structural and Higher Order Structure Analysis, Glycosylation, and Pre-Formulation/Formulation Development Support.
Unlock the full potential of your bioanalysis with our cutting-edge platforms. Our portfolio includes industry-leading Ligand Binding Assay, Cell-Based Assay, Flow-Cytometry, IHC, PCR, NGS, LC/MS and more, providing you with a comprehensive solution for your research needs.
We provide complete trial support services, including lab manual preparation, site training, kit assembly, sample handling, testing, data transfer and regulatory affairs. Our team ensures a smooth trial process from start to finish.
Navigate the regulatory landscape effortlessly with our comprehensive consulting services. From project life-cycle management to technical document review, SOP development, and FDA deficiency response, we offer end-to-end support. Trust us for expert guidance and support.
To deliver unparalleled quality in every aspect of our work, striving for accuracy, reliability, and excellence in all that we do.
To cultivate meaningful, long-lasting partnerships with our clients, working together to achieve their research goals and exceed expectations.
Inspiring progress through innovation – we strive to create new solutions and advance the industry, always keeping our clients’ success at the forefront.
Whether you need support in discovering your niche, fine-tuning your strategy, or executing your plan, we have the experience and expertise to guide you every step of the way.
We specialize in pharmacokinetic analysis of macromolecular drugs, including monoclonal antibodies, peptides, and more. Our bioanalytical methods conform to GLP regulations and are used to support preclinical and clinical trials. Our team has extensive experience in evaluating accuracy, precision, stability, and more to ensure high-quality results.
We specialize in immunogenicity testing of drugs. Our research focuses on detecting and characterizing anti-drug antibodies (ADA) which can cause adverse immune reactions. Our methods include screening, testing, and titer tests on antibody-positive samples. Our testing methods are validated with parameters such as precision, specificity, and stability. We are a professional biological analysis lab following GLP standards.
We offer comprehensive support for companion diagnostic development, from method development to reagent generation and kit production. Our expertise in this field ensures that your companion diagnostic will be of the highest quality, accurately identifying patients who will benefit from targeted treatment.
We offer expertise in pharmacodynamics, including services in immuno-phenotyping, receptor occupancy, tumor mutation burden, minimum residue disease and biomarker analysis.
We offer comprehensive product quality control services, including General and Compendial Testing, Impurities Testing, Potency Testing, Stability studies, Structural Analysis and Glycosylation analysis. Our experts use a range of techniques, such as Mass-spec based structural analysis, Circular Dichroism and N-glycan profiling, to ensure the highest quality standards.
By combining our trial support services with our regulatory affairs expertise, we offer a one-stop solution to help you navigate the complexities of clinical trials and bring your product to market successfully.
New Jersey
259 Prospect Plains Rd
Cranbury, NJ, 08512
732.783.7398
bd@accurantbiotech.com
Shanghai
Room 505, Floor 5
No. 8, Jiafeng Rd.
Free Trade Zone
Shanghai, China
Ningbo
Floor 4, Building A5
No. 587, Juxian Rd.
High-Tech Zone
Ningbo, China
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