Avance Biosciences™ is excited to announce that we will be exhibiting at AAPS PharmSci 360 2026, taking place October 25–28 in New Orleans, LA. Visit us at Booth #1643 to meet our team and discuss bioanalytical and analytical strategies for biologics, cell and gene therapies, and other complex therapeutic modalities.
This year, Avance Biosciences will highlight bioanalytical and CMC testing services that address critical development and regulatory questions, with a particular focus on bioanalytical method development and validation, immunogenicity (ADA) testing, biomarker and PK/PD testing, and potency and biologics characterization. Our scientists combine advanced molecular, genomic, bioanalytical, and cell-based technologies with extensive assay development, qualification, and validation experience to support programs from preclinical development through clinical trials and commercialization.
Bioanalytical Method Development and Validation
Robust bioanalytical methods are essential for generating reliable data throughout the drug development lifecycle. Avance Biosciences provides method development, qualification, and validation services designed to meet evolving regulatory guidance for ligand-binding assays, PK/PD assays, and other bioanalytical platforms.
Our capabilities include ELISA, MSD, flow cytometry, and qPCR/ddPCR-based approaches, supporting sponsors from early feasibility work through GLP-compliant validated testing.
Immunogenicity (ADA) Testing
Understanding a product’s immunogenicity risk is a critical component of developing biologics, cell therapies, and gene therapies. Avance Biosciences provides anti-drug antibody (ADA) assay development, validation, and testing services designed to detect and characterize immune responses to therapeutic products.
Our tiered testing approach, including screening, confirmatory, and titer assays, along with neutralizing antibody (NAb) testing, supports sponsors in meeting regulatory expectations for immunogenicity risk assessment.
Biomarker and PK/PD Testing
Biomarker and pharmacokinetic/pharmacodynamic (PK/PD) data provide critical insight into a therapeutic product’s mechanism of action, exposure, and clinical response. Avance Biosciences offers biomarker discovery and testing, along with PK/PD assay development and validation, to support both preclinical and clinical development programs.
Our scientists work closely with sponsors to design fit-for-purpose assays that can evolve from exploratory biomarker work through validated clinical testing.
Potency and Biologics Characterization
Potency is a critical quality attribute for biologics, including monoclonal antibodies, bispecifics, antibody-drug conjugates (ADCs), and other complex therapeutic modalities. Avance Biosciences provides potency assay development, qualification, validation, and testing services designed to measure biological activity related to a product’s intended mechanism of action.
Our capabilities include cell-based potency assays, flow cytometry, ELISA, and MSD, supporting biologics characterization from early development through commercial release testing.
Meet Avance Biosciences at Booth #1643
AAPS PharmSci 360 brings together scientists, developers, and industry leaders from academia, industry, CDMOs, and regulatory bodies to discuss the latest advances in pharmaceutical sciences. We look forward to meeting with attendees and discussing how Avance Biosciences can provide the bioanalytical expertise, technologies, and regulatory-aligned testing needed to support your development programs.
Contact our technical team to discuss how we can support your bioanalytical and biologics characterization needs.
We look forward to seeing you in New Orleans!
Advance your program with Avance Biosciences’ assay development and validation services for advanced therapies. Our experts partner with you to deliver robust, compliant assays that generate reliable data to support development and regulatory success. Contact Avance today to see how we can support your therapy.
