Therapeutic Monoclonal Antibodies: From Lot Release to Stability Testing 1st Edition

Capture the cutting edge of biopharmaceutical quality science with Therapeutic Monoclonal Antibodies: From Lot Release to Stability Testing, 1st Edition by Harleen Kaur — an essential guide for scientists, QC professionals, and regulatory teams working with mAbs worldwide.

Start with clear, practical insights into the complete lot-release workflow: analytical strategies, assay validation, release criteria, and stability study design tailored specifically for therapeutic monoclonal antibodies. The book demystifies complex concepts with real-world examples, making advanced topics accessible without sacrificing technical rigor.

Discover targeted chapters on accelerated and real-time stability testing, forced-degradation approaches, critical quality attributes, and risk-based protocols that align with global regulatory expectations including FDA, EMA, and ICH guidelines. With focused discussions on biosimilar comparability, formulation challenges, and container-closure considerations, this volume equips you to make confident decisions in development, manufacturing, and quality assurance.

Whether you’re leading a stability program in an international biopharma company, setting up lot release testing in a contract lab, or preparing regulatory submissions, Harleen Kaur’s authoritative yet readable approach turns technical detail into actionable practice. Expect clear methods, troubleshooting tips, and best-practice recommendations that save time and reduce risk.

Enhance your team’s competence and accelerate product readiness with this indispensable resource. Add Therapeutic Monoclonal Antibodies: From Lot Release to Stability Testing to your professional library today — the practical reference for global mAb quality and stability testing.

Note: eBooks do not include supplementary materials such as CDs, access codes, etc.