TY - JOUR
T1 - Stabilizing vaccines via drying
T2 - Quality by design considerations
AU - Ghaemmaghamian, Zahra
AU - Zarghami, Reza
AU - Walker, Gavin
AU - O'Reilly, Emmet
AU - Ziaee, Ahmad
N1 - Publisher Copyright:
© 2022 The Authors
PY - 2022/8
Y1 - 2022/8
N2 - Pandemics and epidemics are continually challenging human beings’ health and imposing major stresses on the societies particularly over the last few decades, when their frequency has increased significantly. Protecting humans from multiple diseases is best achieved through vaccination. However, vaccines thermal instability has always been a hurdle in their widespread application, especially in less developed countries. Furthermore, insufficient vaccine processing capacity is also a major challenge for global vaccination programs. Continuous drying of vaccine formulations is one of the potential solutions to these challenges. This review highlights the challenges on implementing the continuous drying techniques for drying vaccines. The conventional drying methods, emerging technologies and their adaptation by biopharmaceutical industry are investigated considering the patented technologies for drying of vaccines. Moreover, the current progress in applying Quality by Design (QbD) in each of the drying techniques considering the critical quality attributes (CQAs), critical process parameters (CPPs) are comprehensively reviewed. An expert advice is presented on the required actions to be taken within the biopharmaceutical industry to move towards continuous stabilization of vaccines in the realm of QbD.
AB - Pandemics and epidemics are continually challenging human beings’ health and imposing major stresses on the societies particularly over the last few decades, when their frequency has increased significantly. Protecting humans from multiple diseases is best achieved through vaccination. However, vaccines thermal instability has always been a hurdle in their widespread application, especially in less developed countries. Furthermore, insufficient vaccine processing capacity is also a major challenge for global vaccination programs. Continuous drying of vaccine formulations is one of the potential solutions to these challenges. This review highlights the challenges on implementing the continuous drying techniques for drying vaccines. The conventional drying methods, emerging technologies and their adaptation by biopharmaceutical industry are investigated considering the patented technologies for drying of vaccines. Moreover, the current progress in applying Quality by Design (QbD) in each of the drying techniques considering the critical quality attributes (CQAs), critical process parameters (CPPs) are comprehensively reviewed. An expert advice is presented on the required actions to be taken within the biopharmaceutical industry to move towards continuous stabilization of vaccines in the realm of QbD.
KW - Biological solids
KW - Continuous manufacturing
KW - Quality by design
KW - Solid dosage forms
KW - Vaccine drying
UR - http://www.scopus.com/inward/record.url?scp=85134426702&partnerID=8YFLogxK
U2 - 10.1016/j.addr.2022.114313
DO - 10.1016/j.addr.2022.114313
M3 - Review article
C2 - 35597307
AN - SCOPUS:85134426702
SN - 0169-409X
VL - 187
SP - 114313
JO - Advanced Drug Delivery Reviews
JF - Advanced Drug Delivery Reviews
M1 - 114313
ER -