RT Journal Article
SR Electronic
T1 Enhancement of Cell-Based Vaccine Manufacturing through Process Intensification
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP 151
OP 162
DO 10.5731/pdajpst.2020.012583
VO 76
IS 2
A1 Whitford, William
A1 SourabiÈ, Alain M.
A1 Varshney, Dushyant B.
YR 2022
UL http://journal.pda.org/content/76/2/151.abstract
AB There are many drivers to intensify the manufacturing of vaccines. The emergence of SARS-CoV-2 has only added to them. Since the pandemic began, we have been seeing an acceleration of vaccine development and approval, including application of novel prophylactic vaccine modalities. We have also seen an increase in the appreciation and general understanding of what had been a somewhat obscure discipline. Concurrently, there has been great interest in the application of new understandings and technology to the intensification of biopharmaceutical processes in general. The marriage of these developments defines the field of vaccine manufacturing process intensification. Difficulties in its implementation include the many disparate vaccine types—from conjugate to hybrid to nucleic acid based. Then, there are the respective and developing manufacturing methods, modes, and platforms—from fermentation of transformed bacteria to the bioreactor culture of recombinant animal cells to production of virus-like particles in transgenic plants. Advances are occurring throughout the biomanufacturing arena, from process development (PD) techniques to manufacturing platforms, materials, equipment, and facilities. Bioprocess intensification refers to systems for producing more product per cell, time, volume, footprint, or cost. The need for vaccine manufacturing process intensification is being driven by desires for cost control, process efficiency, and the heightened pressures of pandemic response. We are seeing great interest in the power of such disciplines as synthetic biology, process simplification, continuous bioprocessing, and digital techniques in the optimization of vaccine PD and manufacturing. Other powerful disciplines here include process automation, improved monitoring, optimized culture materials, and facility design. The intent of this short commentary is to provide a brief review and a few examples of the exciting advances in the equipment, technology, and processes supporting this activity.