The Food and Drug Administration (FDA) first approved PEGylated product in 1990, since then PEGylation, as a modification procedure for enhancing biomedical efficiency and physicochemical properties of therapeutic proteins has been extensively used. Recombinant proteins are prone to rapid degradation due to proteolysis or may have a brief circulating half-life due to low renal filtration. These limitations can be overcome by PEGylation, where polyethylene glycol chains are linked to peptides and protein molecules. The quality by design (QbD) paradigm helps to develop a process design spaces which describes the interactions and multidimensional effects of method variables on critical quality attributes of therapeutic proteins. The complexities involved in manufacturing processes have led to the development of strategies to establish a design space, ensuring reliable and reproducible outcomes. QbD approach in process optimization allows simultaneous screening of process variables, thus reducing the number of tests conducted as compared to the traditional approach based on a trial and error method. An approach to QbD using the design of experiments (DOE) has been used to establish a design space for PEGylation of recombinant proteins. The aim of this paper is to provide a systematic approach for implementing quality by design for development of a protein PEGylation process.
Patel SR, Dasgupta D. Quality by design approach to protein PEGylation: A review. J App Biol Biotech. 2017; 5 (04): 085-089.
1. Veronese F. Peptide and protein PEGylation. Biomaterials. 2001; 22(5):405-417.
2. Li W, Zhan P, De Clercq E, Lou H, Liu X. Current drug research on PEGylation with small molecular agents. Progress in Polymer Science. 2013; 38:421-444.
3. Jain S. Quality by Design (QbD): A comprehensive understanding of implementation and challenges in pharmaceuticals development. International Journal of Pharmacy and Pharmaceutical Sciences. 2014; 6(1):29-35.
4. Chang R, Raw A, Lionberger R, Yu L. Generic development of topical dermatologic products, Part II: Quality by design for topical semisolid products. The AAPS Journal. 2013; 15(3):674-683.
5. ICH Harmonised tripartite guideline for pharmaceutical development Q8 (R2). 2009. Available from: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q8_R1/Step4/Q8_R2_Guideline.pdf.
6. ICH Harmonised tripartite guideline for pharmaceutical development Q9. 2005. Available from: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q9/Step4/Q9_Guideline.pdf.
7. ICH Harmonised tripartite guideline for pharmaceutical development Q10. 2005. Available from: https://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q10/Step4/Q10_Guideline.pdf.
8. Meitz A, Sagmeister P, Langemann T, Herwig C. An integrated downstream process development strategy along QbD principles. Bioengineering. 2014; 1(4):213-230.
9. Elliott P, Billingham S, Bi J, Zhang H. Quality by design for biopharmaceuticals: a historical review and guide for implementation. Pharmaceutical Bioprocessing. 2013; 1(1):105-122.
10. Rathore A, Pathak M, Godara A. Process development in the QbD paradigm: role of process integration in process optimization for production of biotherapeutics. Biotechnology Progress. 2015; 32(2):355-362.
11. Patil A, Pethe A. Quality by Design (QbD): A new concept for development of quality pharmaceuticals. International Journal of Pharmaceutical Quality Assurance. 2013; 4(2):13-19.
12. Boussès C, Ferey L, Vedrines E, Gaudin K. Using an innovative combination of quality-by-design and green analytical chemistry approaches for the development of a stability indicating UHPLC method in pharmaceutical products. Journal of Pharmaceutical and Biomedical Analysis. 2015; 115:114-122.
13. Nagar M, Singhai S, Chopra V, Bala I, Trivedi P. A study over effects of process parameters on quality attributes of a tablet by applying “quality by design”. Der Pharmacia Lettre. 2010; 2(2): 370392.
14. Payne R, Murphy B, Manning M. Product development issues for PEGylated proteins. Pharmaceutical Development and Technology. 2010; 16(5):423-440.
15. Fahmy R, Kona R, Dandu R, Xie W, Claycamp G, Hoag S. Quality by design I: Application of Failure Mode Effect Analysis (FMEA) and Plackett-Burman design of experiments in the identification of “main factors” in the formulation and process design space for roller-compacted ciprofloxacin hydrochloride immediate-release tablets. AAPS Pharm SciTech. 2012; 13(4):1243-1254.
16. Shivhare M, McCreath G. Practical considerations for DOE implementation in quality by design. BioProcess Technical. 2010, pp. 22-30.
17. Sangshetti J, Deshpande M, Zaheer Z, Shinde D, Arote R. Quality by design approach: regulatory need. Arabian Journal of Chemistry. 2014.
18. Rathore A, Winkle H. Quality by design for biopharmaceuticals. Nature Biotechnology. 2009; 27(1):26-34.
19. Misar S, Ansari M, Derle D, Bhalerao K. Quality by design: a paradigm for industry. International Journal of Pharmaceutical Sciences Review and Research. 2014; 28(1):67-74.
68 Absract views 132 PDF Downloads 200 Total views