Avance Biosciences is a prominent Contract Research Organization (CRO) and Contract Testing Organization (CTO) that specializes in providing CGMP and GLP-compliant analytical and bioanalytical services to facilitate drug development and manufacturing. The company employs a range of advanced technologies, including real-time PCR, ddPCR, Sanger sequencing, next-generation sequencing, ELISA, and flow cytometry, to deliver high-quality assay development, validation, and sample testing services. Their commitment to quality is underscored by adherence to stringent regulatory standards set by the U.S. Food and Drug Administration and other international agencies, ensuring that their methodologies meet the necessary compliance requirements for various therapeutic products.

In addition to their analytical capabilities, Avance Biosciences offers comprehensive support for preclinical and clinical studies, focusing on pharmacokinetics and pharmacodynamics (PK/PD) properties of therapeutic drugs. Their expertise extends to potency assay development, which is crucial for cell and gene therapy products, ensuring that clients meet FDA requirements for investigational new drug applications. The company emphasizes a collaborative approach, working closely with clients to customize assays and optimize methodologies, while maintaining a strong focus on timely delivery and data integrity throughout the drug development process.

United States

Avance Biosciences is a leading CRO providing GLP & GMP-compliant assay development, assay validation, and sample testing services to support biological drug development and manufacturing activities world-wide.
We provide customized solutions for cell and gene therapies testing including: ID testing by Sanger and NGS sequencing , next-gen sequencing on/off target assays, preclinical DNA & RNA biodistribution studies, mRNA Drug Product, Drug Substance and raw material testing including ID and...

Avance Biosciences

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