virus concentration/chromatography, 184–188

economic drivers, 4–5

emerging technologies, 231

envelope, 19

gag-based VLPs, 239–259

additives to increase transient transfection,

248–249

cell culture modes, 249–256

cell lines/plasmids, 248

characterization/quantification of VLPs,

258–259

examples of GAG-based VLPs, 256

HIV-1 GAG VLPs, 241–245

improving production process, 247–256

optimization of TGE, 248

PEI-mediated transient transfection, 245–247

production of HIV-1 GAG VLPs, 245–247

scalable DSP for HIV-1 GAG VLPs, 256–258

serum-free media, 247–248

virus-like particles, 239–241

genome, 19–22

harvest and clarification, 179–184

helper T-cells, 46–47

historical background of vaccines, 1–2

hydrocyclone, 160–161

immunology, 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

RNA vaccine, 53

subunit vaccine, 51–52

T-cell recognition, 46

vaccine design, 49–51

implications of process phase on analytics

choices, 203–205

inactivated influenza vaccine (IIV), 229–230

inactivated virus, 51

inclined settler, 159–160

infectious particle quantification, 205–208

influenza vaccine downstream processing, 233

innate immune system, 37–40

cells of innate immune system, 38

natural killer cells, 40

phagocytes, 39

cytokines and chemokines, 38

pattern recognition receptors, 37–38

live attenuated influenza vaccines (LAIVs),

230–231

manufacturing, 225–238

annual cycle for influenza vaccine

manufacturing, 227–228

downstream processing of influenza

vaccines, 233

influenza vaccines, 228–231

emerging technologies, 231

inactivated influenza vaccine (IIV),

229–230

live attenuated influenza vaccines

(LAIVs), 230–231

recombinant vaccines, 231

influenza virus, 226–227

influenza virus quantification, 231–233

manufacturing challenges, 10–13

motivation for process intensification, 139–140

off-line, at-line, on-line, and in-line

definitions, 218

pandemic preparedness, 13

parameters for process comparison/ evaluation,

140–143

polishing, 189

process analytical technology

viral production, 218–220

process understanding/high throughput process-

development, 190–191

production processes analytics, 201–224

biological attributes of virus-based products,

202–203

implications of process phase on analytics

choices, 203–205

in-line analytics, 217–220

infectious particle quantification, 205–208

process analytical technology viral production,

218–220

regulatory context for analytics development,

201–202

total viral particles quantification, 208–217

viral product analysis, 202–205

viral quantification methods, 205–217

immuno-based assay, 213–215

particle counters, 215–217

public health organizations and industry, 2–4

316

Index