Immunogenicity & Bioassay Resource Library:

PODCAST:

From Cell & Gene Therapy to Biostatistics, a Conversation with Nancy Sajjadi, Independent Quality Consultant
An interview with: Nancy Sajjadi, MSc, Independent Quality Consultant 
(Recorded in September 2019)

ARTICLES:

Recent Issues in Bioanalysis: FDA Immunogenicity Guidance, Gene Therapy, Critical Reagents, Biomarkers and Flow Cytometry Validation

Immunogenicity of TNF-Inhibitors

Development and Validation of a Bordetella pertussis Whole-Genome Screening Strategy

T cell epitope mapping of secukinumab and ixekizumab in healthy donors

Recent Issues in Bioanalysis: FDA BMV Guidance, ICH M10 BMV Guideline and Regulatory Inputs

Best practices in bioassay development to support registration of biopharmaceuticals

Safety and immunogenicity of an anti-Middle East respiratory syndrome coronavirus DNA vaccine: a phase 1, open-label, single-arm, dose-escalation trial

Immunogenicity Manipulation

Immunogenicity of immunomodulatory, antibody-based, oncology therapeutics

Implications of Immunogenicity in Drug Development

Bioassay-Guided Isolation of Antiproliferative Compounds from Limbarda crithmoides

Neutralizing Antibody Assay Development

A smartphone-based bioassay for determining relative potency estimated from sigmoidal-response curves and respective measurement uncertainty

SLIDES & PRESENTATIONS:

Immunogenicity analysis of triterpene glycoside from holothuria atra to detecting fas and BCL-2 protein on the SP-C1 cell of tongue carcinoma

CINF 24: BioAssay express: Creating and exploiting assay metadata

Pegylated Proteins in Anti-cancer Therapy

Functional Bioassays for Immune Check Point Inhibitor Screening and I/O Selection