Index

acoustic settler, 162–163

adaptive immune system, 40–47

humoral response, 41–42, 44–46

antibody effector functions, 44–46

antigens and epitopes, 44

B-cells, 41–42

immunoglobulin/antibodies, 42

humoral response, 41–46

adenovirus-vectored vaccines, 270–281

AdV-based COVID-19 vaccine, 280–281

AdV-based Ebola vaccine, 280

AdV structure and vector design, 276–277

cell line selection, 277

examples of AdV-based vaccines, 279–281

limitations in production of AdV, 277–278

production process of AdV vectors, 277–279

productivity of AdV, 278–279

quantitation methods of AdV vector, 279

veterinary vaccines, 279–280

alternating tangential flow, 155–157

annual cycle for influenza vaccine manufacturing,

227–228

batch cultures to intensified processes, 143–146

capsid, 19

cell attachment/use of microcarriers, 94–95

cell-culture production processes, 8–10

cell lines, 57–78

cell banks, 62

cell-based assays, 70–75

cell line-based assays, 72–74

potency tests, 72–74

control of viral risk in future, 74–75

safety tests, 70–72

new technologies, 71–72

safety tests, 70–71

in vitro and in vivo safety tests, 70–71

technology evolution, 63

viral safety, 63–70

raw materials, 70

viral seeds, 62–63

cell lines/ virus production, 87–95

cell retention devices, 149–163

acoustic settler, 162–163

alternating tangential flow, 155–157

disc centrifuge, 157–159

hydrocyclone, 160–161

inclined settler, 159–160

spin filters, 152–153

tangential flow filtration, 153–155

COVID-19, 293–314

future perspectives, 310–311

regulation of vaccines, 304–307

adenovirus vectored COVID-19 vaccines,

306–307

adenovirus vectored vaccines, 305

protein sub-unit vaccines, 308–310

whole virus vaccines, 307–308

RNA vaccines, 299–304

mRNA vaccine design, 300–301

mRNA vaccine manufacturing, 301–302

stability/efficacy of mRNA vaccines,

302–304

SARS-COV-2, 297–310

biology, 295–296

immunology/vaccine rationale, 296–297

critical factors for virus production at high cell

density, 146–149

cytotoxic T-cells, 47

defining viruses, 17–18

design of vaccine, 35–56

adaptive immune system, 40–47

B-cell response, 41–42

humoral response, 41–46

cytotoxic T-cells, 47

DNA vaccine, 52–53

helper T-cells, 46–47

inactivated virus, 51

innate immune system, 37–40

cells of innate immune system, 38

cytokines and chemokines, 38

pattern recognition receptors, 37–38

live attenuated virus, 51

subunit vaccine, 51–52

T-cell recognition, 46

disc centrifuge, 157–159

disposables, 163–166

DNA vaccine, 52–53

downstream processing, 175–200

harvest and clarification, 179–184

new facility design, 192

polishing, 189

process intensification, 192–194

process understanding/high throughput

process-development, 190–191

purification strategies, 178–189

traditional methods for virus purification,

177–178

viral-based vaccines manufacturing--current

challenges, 176–177

315