Roadmap for implementation of quality by design (QbD) for biotechnology products

Trends in Biotechnology

Volumn 27, Issue 9, 2009, Pages 546-553

  Rathore, Anurag S ^a  

^a INDIAN INSTITUTE OF TECHNOLOGY DELHI   (India)

Author keywords

[No Author keywords available]

Indexed keywords

BIOTECHNOLOGY INDUSTRY; BIOTECHNOLOGY PRODUCTS; CRITICAL QUALITY; QUALITY BY DESIGNS; REGULATORY GUIDANCE; ROADMAP;

TECHNOLOGICAL FORECASTING;

BIOTECHNOLOGY;

ADVISORY COMMITTEE; BIOTECHNOLOGY; CONTROL STRATEGY; DOCUMENTATION; GOOD MANUFACTURING PRACTICE; GOVERNMENT REGULATION; LIFE CYCLE ASSESSMENT; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROCESS MONITORING; QUALITY CONTROL; REVIEW; RISK ASSESSMENT; RISK MANAGEMENT; SUSTAINABLE DEVELOPMENT; VALIDATION PROCESS;

BIOTECHNOLOGY; DRUG INDUSTRY; PHARMACEUTICAL PREPARATIONS; QUALITY CONTROL; TECHNOLOGY, PHARMACEUTICAL;

EID: 68749083515     PISSN: 01677799     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.tibtech.2009.06.006     Document Type: Review

References (49)

1. Woodcock, J. (2005) Pharmaceutical quality in the 21st century - an integrated systems approach. In AAPS Workshop on Pharmaceutical Quality Assessment - A Science and Risk-Based CMC Approach in the 21st Century
2. Department of Health and Human Services, Food and Drug Administration (2004) PAT Guidance for Industry - A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance
3. International Conference of Harmonisation (2008) ICH Harmonised Tripartite Guideline: Q8(R1) Pharmaceutical Development (http://www.ich.org/LOB/media/MEDIA4986.pdf)
4. International Conference of Harmonisation (2005) ICH Harmonised Tripartite Guideline: Q9 Quality Risk Management (http://www.ich.org/LOB/media/MEDIA1957.pdf)
5. International Conference of Harmonisation (2008) ICH Harmonised Tripartite Guideline: Q10 Pharmaceutical Quality Systems (http://www.ich.org/LOB/media/MEDIA3917.pdf)
6. Rathore A.S., and Winkle H. Quality by design for pharmaceuticals: regulatory perspective and approach. Nat. Biotechnol. 27 (2009) 26-34
7. Kozlowski S., and Swann P. Considerations for biotechnology product quality by design. In: Rathore A.S., and Mhatre R. (Eds). Quality by Design for Biopharmaceuticals: Perspectives and Case Studies (2009), Wiley Interscience 9-30
8. Yu L.X., et al. Applications of process analytical technology to crystallization process. Adv. Drug Deliv. Rev. 56 (2004) 349-369
9. Rathore A.S., et al. Applying process analytical technology to biotech unit operations. BioPharm Int. 19 8 (2006) 48-57
10. Gnoth S., et al. Process analytical technology (PAT): batch-to-batch reproducibility of fermentation processes by robust process operational design and control. J. Biotechnol. 132 (2007) 180-186
11. Harms J., et al. Defining design space for biotech products: case study of Pichia pastoris fermentation. Biotechnol. Prog. 24 (2008) 655-662
12. Rathore A.S., et al. Case study and application of process analytical technology (PAT) towards bioprocessing: use of on-line high performance liquid chromatography (HPLC) for making real time pooling decisions for process chromatography. Biotechnol. Bioeng. 100 (2008) 306-316
13. Nail S.L., and Searles J.A. Elements of quality by design in development and scale-up of freeze-dried parenterals. BioPharm Int. 21 1 (2008) 44-53
14. van Hoek P., et al. Case study on definition of process design space for a microbial fermentation step. In: Rathore A.S., and Mhatre R. (Eds). Quality by Design for Biopharmaceuticals: Perspectives and Case Studies (2009), Wiley Interscience 85-109
15. Cecchini D.J. Applications of design space for biopharmaceutical purification processes. In: Rathore A.S., and Mhatre R. (Eds). Quality by Design for Biopharmaceuticals: Perspectives and Case Studies (2009), Wiley Interscience 127-141
16. Watler P.K., and Rozembersky J. Application of QbD principles to tangential flow filtration operations. In: Rathore A.S., and Mhatre R. (Eds). Quality by Design for Biopharmaceuticals: Perspectives and Case Studies (2009), Wiley Interscience 111-125
17. Ng K., and Rajagopalan N. Application of quality by design and risk assessment principles for the development of formulation design space. In: Rathore A.S., and Mhatre R. (Eds). Quality by Design for Biopharmaceuticals: Perspectives and Case Studies (2009), Wiley Interscience 161-174
18. Lanan M. QbD for raw materials. In: Rathore A.S., and Mhatre R. (Eds). Quality by Design for Biopharmaceuticals: Perspectives and Case Studies (2009), Wiley Interscience 193-210
19. Department of Health and Human Services, Food and Drug Administration (2008) Notice of Pilot Program for Submission of Quality Information for Biotechnology Products in the Office of Biotechnology Products, Food and Drug Administration, Docket number FDA-2008-N-03551
20. Kozlowski S., and Swann P. Current and future issues in the manufacturing and development of monoclonal antibodies. Adv. Drug Deliv. Rev. 58 (2006) 707-722
21. International Conference of Harmonisation (1999) ICH Harmonised Tripartite Guideline: Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (http://www.ich.org/LOB/media/MEDIA432.pdf)
22. Singh S.K., et al. Application of QbD principles to biologic products: formulation and process development. In: Rathore A.S., and Mhatre R. (Eds). Quality by Design for Biopharmaceuticals: Perspectives and Case Studies (2009), Wiley Interscience 176-192
23. Apostol I., et al. A rational approach for setting and maintaining specifications for biological and biotechnology derived products - Part 1. BioPharm Int. 21 6 (2008) 42-54
24. Schofield T., et al. A rational approach for setting and maintaining specifications for biological and biotechnology derived products - Part 2. BioPharm Int. 21 7 (2008) 32-40
25. Schofield T., et al. A rational approach for setting and maintaining specifications for biological and biotechnology derived products - Part 3. BioPharm Int. 21 8 (2008) 44-57
26. Barrett Y.C., et al. Validation and implementation of drug-dependent antibody assays in clinical trials for safety monitoring of patients dosed with roxifiban, an orally bioavailable glycoprotein IIb/IIIa antagonist. J. Pharm. Biomed. Anal. 44 (2007) 938-946
27. Gupta S., et al. Recommendations for the design, optimization, and qualification of cell-based assays used for the detection of neutralizing antibody responses elicited to biological therapeutics. J. Immunol. Methods 321 (2007) 1-18
28. Mire-Sluis A.R., et al. Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products. J. Immunol. Methods 289 (2004) 1-16
29. Schenerman M.A., et al. Using a risk assessment process to determine criticality of product quality attributes. In: Rathore A.S., and Mhatre R. (Eds). Quality by Design for Biopharmaceuticals: Perspectives and Case Studies (2009), Wiley Interscience 53-84
30. Wang X., et al. Using statistical analysis for setting process validation acceptance criteria for biotech products. Biotech. Prog. 23 (2007) 55-60
31. Rathore A.S., et al. Design space for biotech products. BioPharm Int. 20 4 (2007) 36-40
32. Lepore J., and Spavins J. PQLI design space. J. Pharm. Innov. 3 (2008) 79-87
33. Garcia T., et al. PQLI key topics - criticality, design space and control strategy. J. Pharm. Innov. 3 (2008) 60-68
34. Nosal R., and Schultz T. PQLI definition of criticality. J. Pharm. Innov. 3 (2008) 69-78
35. Seely J. Process characterization. In: Rathore A.S., and Sofer G. (Eds). Process Validation in Manufacturing of Biopharmaceuticals (2005), Taylor & Francis 31-68
36. Senger R.S., and Karim M.N. Effect of shear stress on intrinsic CHO culture state and glycosylation of recombinant tissue-type plasminogen activator protein. Biotechnol. Prog. 19 (2003) 1199-1209
37. Butler M. Animal cell cultures: recent achievements and perspectives in the production of biopharmaceuticals. Appl. Microbiol. Biotechnol. 68 (2005) 283-291
38. Kirdar A.O., et al. Application of multivariate analysis for identification and resolution of a root cause for a bioprocessing application. Biotechnol. Prog. 24 (2008) 720-726
39. Rosenberg A.S. Effects of protein aggregates: an immunologic perspective. APPS J. 8 (2006) E501-E507
40. Woodcock J., and Woosley R. The FDA critical path initiative and its influence on new drug development. Annu. Rev. Med. 59 (2008) 1-12
41. Schneider C.K., and Kalinke U. Toward biosimilar monoclonal antibodies. Nat. Biotechnol. 26 (2008) 985-990
42. Konold P., et al. Monitoring of biopharmaceutical processes: present and future approaches. BioPharm Int. 22 5 (2009) 707-722
43. Vesper J.L. Assessing and managing risks in a GMP environment. BioPharm Int. 18 3 (2005) 46-48
44. Seely R.J., and Haury J. Applications of failure modes and effects analysis to biotechnology manufacturing processes. In: Rathore A.S., and Sofer G. (Eds). Process Validation in Manufacturing of Biopharmaceuticals (2005), Taylor & Francis 13-30
45. Shankar G., et al. A risk-based bioanalytical strategy for the assessment of antibody immune responses against biological drugs. Nat. Biotechnol. 25 (2007) 555-561
46. Cook S., et al. Quality by design in the CMO environment. BioPharm Int. 20 12 (2007) 28-37
47. Kirdar A.O., et al. Application of multivariate analysis towards biotech processes: case study of a cell-culture unit operation. Biotech. Prog. 23 (2007) 61-67
48. Munson J., et al. A review of process analytical technology (PAT) in the U.S. pharmaceutical industry. Curr. Pharm. Anal. 2 (2006) 405-414
49. Rathore A.S., et al. Case study and application of process analytical technology (PAT) towards bioprocessing: II. Use of ultra performance liquid chromatography (UPLC) for making real time pooling decisions for process chromatography. Biotech. Bioeng. 101 (2008) 1366-1374