BioAgilytix

BioAgilytix is a leading global contract research organization focused on supporting pharmaceutical and biotech partners in all phases of drug development. With laboratory locations in North Carolina’s Research Triangle Park; Cambridge, Massachusetts; San Diego, California; Melbourne and Brisbane, Australia and Hamburg, Germany, BioAgilytix provides PK, immunogenicity, biomarkers, and cell-based assay services supporting the development and release testing of therapeutics across industries and disease states.

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Strategies for Overcoming Drug Interference in Immunogenicity Assessment

ADA Assessment for Cell Therapies

Total Bioanalytical Support for Antibody−Drug Conjugates (ADCs)

PK Assessment for Advanced Modalities (Cell and Gene Therapies)

Immediate hypersensitivity reactions against biologicals

ELISpot method development and validation for gene therapies: building on 2019 WRIB recommendations, practical case studies, lessons learnt and evolving trends

What the new AAPS White Paper recommends for immunogenicity assays supporting biosimilars

Exploratory biomarker testing: to qualify or validate the assay? The latest scientific and regulatory considerations for biomarker validation

Translation of a diagnostic virus neutralization method to a quantitative relative potency assay for an anti-viral antibody

Challenges of single and multiplex biomarker validation on “planet earth” versus “planet biomarkertopia”

Recent aspects and challenges in the assessment of immunogenicity

Considerations for the evaluation of accuracy, parallelism, and reagent lot to lot variability in single and multiplex biomarker ligand binding assays

Webinar Q&A follow up – Clinical relevance of (unwanted drug-induced) immune responses

Clinical relevance of (unwanted drug-induced) immune responses

Bioanalytical methods in support of biosimilar drug development

The Importance Of GMP Certification In Drug Development – Bioanalytical Lab & Top CRO for Large Molecule Bioanalysis

BioAgilytix and Sword Bio partner to improve immunoassay services

BioAgilytix Expands to Second Campus in Durham, NC

BioAgilytix Announces Appointment Of Dr. Linda Robbie As Chief Operating Officer

BioAgilytix Achieves Cyber Security Accreditation

BioAgilytix appoints Nathan Speicher as Chief Financial Officer

BioAgilytix Appoints Euan Menzies as Chairman and Chief Executive Officer

BioAgilytix Announces New Partnership With CTI – Bioanalytical Lab & Top CRO for Large Molecule Bioanalysis

BioAgilytix announces the launch of COVIDenceTM

Panel discussion: lessons learnt from COVID-19 and lab 4.0

Panel discussion: ICH M10 draft bioanalytical method validation guideline

Pharmacokinetics of Subcutaneously-administered CBX129801, A Long-acting Synthetic C-peptide in Patients with Type 1 Diabetes Mellitus

Pharmacokinetic Bioequivalence of ATI-0918 and DOXIL®/CAELYX® in Patients with Ovarian Cancer

Efficient and Economical Preclinical Pharmacokinetic Analyses

In the Zone: ADA assessment and detection

Infographic: the facts about anti-drug antibodies

ADA assay development: a podcast interview with Lynn Kamen

ADCC and CDC Assay: Validation and Optimization – Bioanalytical Lab & Top CRO for Large Molecule Bioanalysis

Is ISR Needed For Biomarker Assays? – Bioanalytical Lab & Top CRO for Large Molecule Bioanalysis

Determining Immunogenicity for CAR-T cell Therapies – Bioanalytical Lab & Top CRO for Large Molecule

Clinical relevance of immunogenicity: an interview with Arno Kromminga

Exploratory biomarker testing: to qualify or validate the assay?

Evaluating the immunogenicity of antibody–drug conjugates

Website: www.bioagilytix.com

Email: [email protected]

Telephone: 919-381-6097

Address: 2300 Englert Drive, Durham, NC, 27713, USA