top of page
Featured Book: Biopharmaceutical Process Validation: Strategies for Risk Assessment (2025). (1st ed.). Book Writing Pioneer. ISBN: 1968260293
Why This Book Matters for Bioprocess Engineers & Quality ProfessionalsValidation in biopharmaceutical manufacturing is a complex, high-stakes task. The emerging regulatory expectations around quality by design (QbD), lifecycle verification, and risk-based approaches mean that a purely prescriptive “do-it-this-way” approach is no longer sufficient.
This book aims to bridge the gap between theory and practice by providing:
-
Risk-based frameworks rather than just checklistsReal-world examples and case studies
-
Strategies focused on Stage 2 and Stage 3 validation (i.e. process qualification and continued verification)
-
Quantitative methods to support decision making.
In effect, it is a guide intended for the modern bioprocess professional who must not only validate processes but also justify them under regulatory scrutiny.
bottom of page