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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_101_библиотеки_им_акад_М_И_Перельмана
.pdf
https://t.me/med1917
398
398
risk
assessment 97– 99, 323– 324
management 31, 42
ranking 106
rituximab 124
and antibody dependent cell mediated cytotoxicity
(ADCC) 124
robustness and sample stability 143
rocking bioreactor 206, 207
routes of administration 14, 286– 294
S
Saccharomyces cerevisiae, expression systems 169, 170,
177
safety 69– 70
and efcacy relationship 147– 148
sample size
and study duration 155– 156
and variance approach 102
samples
integrity 38
unbiased 104
sampling 63– 64
schedule 147
systems 60
scanning electron microscopy (SEM) 256
screening
peptide libraries 131
for selfness 131
screening assays 144, 144
sealers 63
search resources, patents 352, 352
seed generation process, intensied 192, 192
seed train 191– 195, 192
selectivity 143
sensitivity 143
sensors 214, 216, 257– 259
biomass 58
electrochemical 58– 59
optical 57– 58
pressure 59– 60
sequence listing
side- by- side assessment 146
side- by- side testing 90
signicance level 100
signicant gures 104
similarity
ngerprint- like 12
high 11
simulated moving bed (SMB) 76
chromatography 77
single- use bioreactors (SUB) 53– 56, 55, 60, 225
single- use technology (SUT) 48– 67
advantages of 52– 54
manufacturing 53, 54
size
no one ts all 11
of test 100
size exclusion chromatography 230, 239, 239
skin drug delivery 293
sodium dodecyl sulfate (SDS) 88
SDS- PAGE 93, 99, 194, 202, 256
software patents 357– 358
solid lipid nanoparticles (SLN) 291, 298
solubilization 256
disulde bridges 166
inclusion body (IB) 199, 201, 232, 235– 238, 237
protein 165, 168
sources of variation 84– 94
sparger 214, 216
specications 21, 340– 341
specicity 143
anti- drug antibodies (ADA) 142
specimen and sample tracking 329
stability 24, 41, 95– 96
protein biopharmaceuticals 265, 265
stabilizers 280
Standard Operating Procedures (SOP) 104, 328– 329
Staphylococcus aureus, expression systems 177
State Intellectual Property Ofce (SIPO) 358
statistical analysis 335
statistical concepts 99, 100– 104
statistical considerations 99
statistical evaluation
pharmacodynamics results 120– 122
pharmacokinetics results 120– 122
statistical power 100
stem cell factor (SCF) 274
stem cells 367
stepwise analytical assessment 100
sterile ltration 261– 262
sterilization 225
sterilization- in- place (SIP) 47, 49, 52, 59, 61, 64, 69, 193, 225
stirred- tank bioreactor 201, 204, 205
stirred- tank reactor (STR) 192, 204
straight- through processing (STP) 76– 77, 77
strength 14– 15
structure
attributes 85– 86
changes 265– 266
conrmation 90– 91
studies
crossover design 113
healthy subjects versus patients 112– 113
multiple combined 113
parallel design 113
phase of 12
protocols 152– 153
scope of 111– 112
unied 114
study design 113, 153– 154
and analyses 156
safety and efcacy 150– 151
types of 150– 152
study materials 114
study plan 112– 114
study population 155
study size 113
study waiver 16
Index
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399
Index
subcutaneous administration 288– 290, 289
submarine patent 373
substitution 31, 42
suitability, Certicate of Suitability (CEP) compliance 309,
309, 324
sulfonic acid 66, 274, 280
Supplementary Protection Certicate (SPC) 371– 372
surface plasmon resonance (SPR) 75, 93, 97, 98– 99, 108,
144, 256
surface tension 279
system, review of 315– 316
system expression patents 373
systematic and random errors 333– 334
T
T- cell assays 133
T- cell epitope prediction 130– 131
T- cell receptor (TCR) 127– 128, 130– 131, 140
soluble 137
T- cell- dependent immunogenicity 126– 131
T- cell- dependent responses 127– 128
T- cell- independent responses 127– 128
T- cells, and human leukocyte antigen (HLA) 137
T7 lysozyme 167
tac promoter 194
tangential ow ltration (TFF) 67– 73, 253, 253
Chinese hamster ovary (CHO) cells 253
high- performance (HPTFF) 254
tank liners 50– 52
temperature 259, 272
control 220– 222
and E. coli growth 221, 221
terminology 11
test, size of 100
test procedures 21, 39
testing 71– 73
drug product (DP) 337
Food and Drug Administration (FDA) approvals 36, 36,
37
methods 96– 97
oncology monoclonal antibodies 99
plan 84
plastic lm 71
tetanus toxin 133– 134, 345
therapeutic biologics, immunogenicity 142
Therapeutic Goods Administration (TGA) 15, 311
therapeutic proteins
continuous manufacturing system 78, 78, 79
Escherichia coli 79, 79– 81
third- party analytical assessment 38
third- party process patents 374
three- dimensional bags 52
three- stage purication strategy 228, 229
three- step purication 241, 242
tolerization 135
tonicity 279
totality, of evidence 12
Trade- Related Aspects of Intellectual Property (TRIPS)
357, 366, 370
traditional comparative (two- sided) study 150
transdermal administration 292– 293
transformation vector 160
transgenic animals, expression systems 178
transgenic plants 368
expression systems 178
transmembrane pressure (TMP) 236, 255, 258– 259
transmissible spongiform encephalopathies (TSE) 50, 171
trastuzumab 124
and antibody dependent cell mediated cytotoxicity
(ADCC) 124
treatment costs 1, 2– 4
treatment- induced tolerance 135– 136
trypsin 282
tube welder 63
tubing 62
tumor necrosis factor alpha (TNF- α)
agents 129
binding 98
blockers 10, 96, 98
inhibitors 127– 128
neutralization 98
therapy 129
two one- sided t- test (TOST) 101
two- dimensional bags 51
two- part claim 364– 365
U
ultracentrifugation
analytical (AUC) 93, 97– 99
see also centrifugation
ultraltration 67– 73, 199– 201
and dialtration (UF/ DF) system 254, 255
ultraviolet irradiation 250
ultraviolet monitoring 257
unbiased samples 104
unied study 114
United States patent elements 354– 356
United States Patent and Trademark Ofce (USPTO)
patents 351, 352
web sources 371– 372
United States Pharmacopoeia (USP) 59– 60, 62, 71– 72, 71
upstream equipment 203
user requirement specications (URS) 257
utility model, European union 358– 359
utility tools 120– 121
V
validated samples 38
validation 332
instrumentation 328– 329
validation master plan (VMP) 324– 327
valves 261
variance approach, and sample size 102
vectors
adenovirus 174
baculovirus 178
cloning 165, 177– 178
episomal 169
399
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400
400
expression 44, 161, 164, 169, 176, 369
pBR322 plasmid 163, 165
transformation 160
viral 130, 135, 139, 174– 175
vessel volume exchanges per day (VVD) 214
vial thaw 192
viral vector 130, 135, 139, 174– 175
virus ltration 248– 250, 249
virus removal 67
inactivation 248– 250
validation 250– 253
virus- like particles (VLP) 248, 251
W
waivers 149– 150
web registers 372
wet age- related macular degeneration (WAMD) 293
working cell bank (WCB) 54, 191, 251
World Health Organization (WHO) 18, 311,
350
World Intellectual Property Organization (WIPO) 356,
362
patents 352, 362
X
xenotropic murine leukemia virus (XMuLV) 249,
252
Y
yeast 168– 170
expression systems 169, 170, 177
Index
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