PDA's book, Quality by Design — An Indispensable Approach to Accelerate Biopharmaceutical Product Development, edited by industry experts Cristiana Campa, Vaccines Technical R&D, GSK, and M. Amin Khan , Vaccines R&D, GSK, is an important contribution to the ongoing dialogue for accelerating CMC product development bridging strategies for biotherapeutics and vaccines.
It illustrates how Quality by Design (QbD) can be a powerful enabler of acceleration, fostering deeper understanding of what is critical, what level of CMC risk is acceptable, and hence what elements of product development can be streamlined.
More than 60 authors have contributed to this influential text emphasizing the importance of QbD to product development and commercialization. Several case studies covering biotherapeutics and vaccines are shared by several major companies and well-recognized academic institutions. These case studies illustrate that QbD is a key strategic approach to decide what should be prioritized, enabling both fast product, process, and analytical development, ensuring product safety and efficacy; and phase-appropriate control strategy and comparability, focused on patient needs.
In addition, this book demonstrates how Prior Knowledge is useful to inform QbD-driven risk assessment and focus on non-redundant activities, fostering tailored innovation. Examples of how the use of modelling can be a powerful asset to ensure the streamlined execution of experimental activities (e.g., process, stability, and analytical space) are included.
All of these aspects are covered in the four comprehensive sections of the book, which are organized under the following topics:
- Part I- Product Understanding
- Part II- Process Understanding and Modeling
- Part III- Analytical Strategy and Modeling
- Part IV- Platform Knowledge
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Format: PDF (1 file 59.7 MB)
Table of Contents:
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Part 1: Introduction
Part II: Product Understanding
Section 1: Critical Quality Attributes and Ranges
Section 2: Formulation Development
Section 3: Stability Modeling
Section 4: Comparability
Part III: Process Understanding and Modeling
Section 5: Process Understanding and Modeling
Part IV: Analytical Strategy and Modeling
Section 6: Analytical Strategy and Modeling
Part V: Platform Knowledge
Section 7: Platform Knowledge
Part VI: Conclusions