This document discusses quality by design (QbD) approaches for biopharmaceutical development. QbD focuses on designing quality into the product and process based on an understanding of critical quality attributes and critical process parameters. Key aspects of QbD include identifying critical attributes and parameters, using tools like design of experiments to understand their impact, defining a design space, and ensuring robustness through continuous monitoring and improvement. Statistical tools and multidisciplinary teams are important for successful QbD implementation.

1. Quality by DesignDevelopment, optimization and robustness by DesignMayank

2. Global initiatives

3. Global initiativesReferences1. ICH, Q8(R1) Pharmaceutical Development (Geneva, Switzerland, Nov. 10, 2005; Rev. 2008). 2. ICH, Q9 Quality Risk Management (Geneva, Switzerland, Nov. 9. 2005). 3. J. Agalloco et al., "FDA's Guidance for Industry: Process Validation: General Principles and Practices," presented at PDA, Jan. 14, 2009. 4. FDA, Draft Guidance for Industry—Process Validation: General Principles and Practices (Rockville, MD, Nov. 2008). 5. W. Charlton, T. Ingallinera, and D. Shive, "Validation of Clinical Manufacturing," and Validation Chapter, in Validation of Pharmaceutical Process, J. Agalloco and F. Carleton, eds. (Informa Healthcare, New York, 3rd ed., 2008), pp. 542–544.

4. Quality by design (QbD)What is QbD?Product and process performance characteristics are scientifically designed to meet specific objectives, not merely empirically derived from performance of test batchesFocus during developmentCritical Quality Attributes (CQA)eg. USPDSPCell viability

5. Cell count

6. Titre

7. Product characteristics (egGlycocylation)

8. Impurity profile

9. Overall purity

10. Type of impurity (eg HCP, endotoxins, DNA,)

11. Yield Critical Process Parameter (CPP)Column bed height and packing efficiency

12. Media selectivity

13. Media particle size

14. Dynamic capacity

15. Buffer conditions (eg pH, conductivity)

16. Temperature

17. Flow rate

18. Sample load

19. Temperature

20. pH

21. Agitation

22. DO

23. Medium composition

24. Osmolarity

25. Feed type

26. Process type (eg Batch, fed batch or perfustion)Quality by design (QbD)Tools for successful implementation of QbDTeam:Engineers

27. Biologists

28. Analysts

29. Chemists

30. Industrial pharmacist

31. SatiationsAnalytical equipmentsOnline/Atline

32. NIR detectors

33. Methanol sensors

34. CO2/O2 probes