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Filtration and Purification in the Biopharmaceutical Industry
DRUGS AND THE PHARMACEUTICAL SCIENCES A Series of Textbooks and Monographs Executive Editor James Swarbrick PharmaceuTech, Inc. Pinehurst, North Carolina Larry L. Augsburger University of Maryland Baltimore, Maryland Jennifer B. Dressman University of Frankfurt Institute of Pharmaceutical Technology Frankfurt, Germany Anthony J. Hickey University of North Carolina School of Pharmacy Chapel Hill, North Carolina Ajaz Hussain Sandoz Princeton, New Jersey Joseph W. Polli GlaxoSmithKline Research Triangle Park North Carolina Stephen G. Schulman University of Florida Gainesville, Florida Yuichi Sugiyama University of Tokyo, Tokyo, Japan Geoffrey T. Tucker University of Sheffield Royal Hallamshire Hospital Sheffield, United Kingdom Advisory Board Harry G. Brittain Center for Pharmaceutical Physics Milford, New Jersey Robert Gurny Universite de Geneve Geneve, Switzerland Jeffrey A. Hughes University of Florida College of Pharmacy Gainesville, Florida Vincent H. L. Lee US FDA Center for Drug Evaluation and Research Los Angeles, California Kinam Park Purdue University West Lafayette, Indiana Jerome P. Skelly Alexandria, Virginia Elizabeth M. Topp University of Kansas Lawrence, Kansas Peter York University of Bradford School of Pharmacy Bradford, United Kingdom
Page 4 and 5: 1. Pharmacokinetics, Milo Gibaldi a
Page 6 and 7: 55. Radiopharmaceuticals: Chemistry
Page 8 and 9: 107. Drug Stability: Principles and
Page 10: 156. Pharmacogenomics: Second Editi
Page 13: Informa Healthcare USA, Inc. 52 Van
Page 18: Foreword Filtration has been used s
Page 21 and 22: viii Preface describing essential p
Page 23 and 24: x Contents 14. Extractables and Lea
Page 25 and 26: xii Contributors Theodore H. Meltze
Page 27 and 28: 2 Quigley liquids. The problem can
Page 29 and 30: 4 Quigley FIGURE 3 Diatoms in diato
Page 31 and 32: 6 Quigley This inertial force depen
Page 33 and 34: 8 Quigley Adsorption Activated Carb
Page 35 and 36: 10 Quigley easier to change than a
Page 37 and 38: 12 Quigley The graded pore size for
Page 39 and 40: 14 Quigley FIGURE 15 Depth and memb
Page 41 and 42: 16 Quigley The proper cake formatio
Page 43 and 44: 18 Quigley The sterile bulk albumin
Page 45 and 46: 20 Quigley When running a forward f
Page 48 and 49: 2 Charge Modified Filter Media Euge
Page 50 and 51: Charge Modified Filter Media 25 pro
Page 52 and 53:
Charge Modified Filter Media 27 saf
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Charge Modified Filter Media 29 FIG
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Charge Modified Filter Media 35 At
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Charge Modified Filter Media 43 DNA
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Charge Modified Filter Media 45 Hag
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3 Filter Designs Suraj B. Baloda Mi
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Filter Designs 49 The most common 4
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Filter Designs 51 Multiple steps an
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Filter Designs 53 air filtration or
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Filter Designs 55 pleat pack that c
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Filter Designs 57 FIGURE 7 Differen
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Filter Designs 59 the tailoring of
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Filter Designs 61 measured. This gi
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Filter Designs 63 FIGURE 12 (A) Pil
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4 Pore Sizes and Distributions C. T
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Pore Sizes and Distributions 67 Fil
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Pore Sizes and Distributions 69 FIG
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Pore Sizes and Distributions 71 pre
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Pore Sizes and Distributions 73 whe
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Pore Sizes and Distributions 79 fil
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82 Meltzer and Jornitz The pore str
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84 Meltzer and Jornitz Pore Size Di
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86 Meltzer and Jornitz The dilution
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88 Meltzer and Jornitz per cm 2 EFA
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90 Meltzer and Jornitz TABLE 2 Rete
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92 Meltzer and Jornitz FIGURE 9 B.
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94 Meltzer and Jornitz Viscosity Vi
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96 Meltzer and Jornitz TABLE 5 Rete
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98 Meltzer and Jornitz fluid in its
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100 Meltzer and Jornitz TABLE 7 Flu
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102 Meltzer and Jornitz THE MODELIN
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104 Meltzer and Jornitz FIGURE 12 P
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106 Meltzer and Jornitz the mechani
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108 Meltzer and Jornitz filters in
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110 Meltzer and Jornitz particles f
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112 Meltzer and Jornitz from the el
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114 Meltzer and Jornitz modified to
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116 Meltzer and Jornitz This finds
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118 Meltzer and Jornitz The hydroge
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120 Meltzer and Jornitz Solvating E
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122 Meltzer and Jornitz filter’s
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124 Meltzer and Jornitz bonding of
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126 Meltzer and Jornitz and strongl
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128 Meltzer and Jornitz bacteria ne
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130 Meltzer and Jornitz The Electri
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132 Meltzer and Jornitz namely VDW
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134 Meltzer and Jornitz (non-flowin
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136 Meltzer and Jornitz hydrocarbon
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138 Meltzer and Jornitz neutralized
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140 Meltzer and Jornitz Interesting
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142 Meltzer and Jornitz the endotox
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144 Meltzer and Jornitz (1) The equ
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146 Meltzer and Jornitz Bowman FW,
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148 Meltzer and Jornitz Ridgway HF.
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6 Microbiological Considerations in
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Microbiological Considerations 153
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164 Meltzer and Jornitz some lower
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166 Meltzer and Jornitz taken that
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168 Meltzer and Jornitz 8. Initial
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170 Meltzer and Jornitz flow decrea
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172 Meltzer and Jornitz FIGURE 3 Pa
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174 Meltzer and Jornitz FIGURE 5 Se
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176 Meltzer and Jornitz Homogeneous
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178 Meltzer and Jornitz Prefilter A
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180 Meltzer and Jornitz upon the us
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182 Meltzer and Jornitz obtained by
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184 Meltzer and Jornitz published.
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186 Meltzer and Jornitz If flow dec
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188 Meltzer and Jornitz effect, the
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190 Meltzer and Jornitz differentia
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192 Meltzer and Jornitz Trotter AM,
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194 Bardo We will survey key aspect
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196 Bardo corrosion cracking, inclu
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198 Bardo were to skip any of the m
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200 Bardo stainless steel and other
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202 Bardo all the obligations requi
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204 Bardo built into the top plate,
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206 Bardo often called domes or she
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208 Bardo FIGURE 3 T-style sanitary
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210 Bardo In multi-round sanitary h
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212 Bardo FIGURE 6 (A) 222- and (B)
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214 Bardo Cartridge replacement. St
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216 Bardo ever larger. As the bioph
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218 Bardo n Difficult to scale-up n
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220 Bardo that is free of many of t
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222 Bardo TABLE 3 Comparison of Sta
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224 Bardo From this productive amal
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226 Bardo n integrity testing, n va
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228 Bardo CONCLUSION The evolution
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9 Stainless Steel Application and F
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Stainless Steel Application and Fab
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258 Meltzer operational mechanism (
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260 Meltzer adsorptive interactions
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262 Meltzer surfaces to which they
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264 Meltzer matter, the bovine seru
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266 Meltzer FIGURE 2 Outer coats of
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268 Meltzer molecular arrangements
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270 Meltzer Extents of adsorption d
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272 Meltzer Qualitative Measurement
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274 Meltzer albumin solution, etc.
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276 Meltzer hydrophobic bonding. An
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278 Meltzer network. Thus, the mole
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280 Meltzer FIGURE 8 The hydrogen b
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282 Meltzer TABLE 4 Flu-Vaccine Fil
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284 Meltzer feedstream. At this poi
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286 Meltzer FIGURE 10 Different pro
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288 Meltzer factors, the short rang
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290 Meltzer plotted trace signals b
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292 Meltzer instead of flat membran
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294 Meltzer Characklis WG. Microbia
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11 The Filter Integrity Tests Theod
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The Filter Integrity Tests 299 befo
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The Filter Integrity Tests 301 side
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The Filter Integrity Tests 303 the
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The Filter Integrity Tests 305 supe
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The Filter Integrity Tests 307 thes
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The Filter Integrity Tests 309 Data
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The Filter Integrity Tests 311 The
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The Filter Integrity Tests 313 FIGU
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The Filter Integrity Tests 315 may
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The Filter Integrity Tests 317 pres
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The Filter Integrity Tests 321 Due
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The Filter Integrity Tests 323 Log
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The Filter Integrity Tests 325 Pres
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The Filter Integrity Tests 327 filt
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The Filter Integrity Tests 329 are
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The Filter Integrity Tests 335 test
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The Filter Integrity Tests 337 Is t
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The Filter Integrity Tests 339 (Tro
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The Filter Integrity Tests 341 an i
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The Filter Integrity Tests 345 The
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The Filter Integrity Tests 347 EMEA
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The Filter Integrity Tests 349 Waib
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352 Jornitz For this reason vendors
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354 Jornitz Nevertheless, the vendo
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356 Jornitz meaning every step requ
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358 Jornitz successes will also ens
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360 Jornitz components are required
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362 Jornitz API WFI Higher Risk or
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364 Jornitz FIGURE 9 Typical flow d
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366 Jornitz is supplied to assure a
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368 Jornitz FIGURE 12 Validation sc
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13 Validation of the Filter and of
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Validation of the Filter and of the
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390 Colton and Bestwick FIGURE 1 Cr
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392 Colton and Bestwick such as pol
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394 Colton and Bestwick Filters use
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396 Colton and Bestwick 3. Composit
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398 Colton and Bestwick Another con
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400 Colton and Bestwick This experi
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402 Colton and Bestwick and leachab
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404 Colton and Bestwick The mass fr
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406 Colton and Bestwick through the
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408 Colton and Bestwick Alternative
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410 Colton and Bestwick Modeling Le
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15 Endotoxin, Limulus Amebocyte Lys
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Endotoxin, Limulus Amebocyte Lysate
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426 Gould thousand to roughly 25,00
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428 Gould different endotoxin prepa
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430 Gould Because turbidity can be
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432 Gould ERROR OF THE LAL TEST The
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434 Gould qualification of the LAL
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436 Gould promotes adsorption and d
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438 Gould Twohy CW, Nierman ML, Dur
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440 Jornitz and Meltzer form a high
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442 Jornitz and Meltzer Another imp
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444 Jornitz and Meltzer commonly sh
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446 Jornitz and Meltzer required to
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448 Jornitz and Meltzer FIGURE 10 F
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450 Jornitz and Meltzer filter devi
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452 Jornitz and Meltzer filter (600
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454 Jornitz and Meltzer FIGURE 15 F
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456 Jornitz and Meltzer the end use
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18 Downstream Processing Uwe Gottsc
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Downstream Processing 461 medium wi
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Downstream Processing 463 explore s
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Downstream Processing 465 (A) (B) S
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Downstream Processing 467 impuritie
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Downstream Processing 469 TABLE 1 D
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Downstream Processing 471 (A) (B) S
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Downstream Processing 473 n flux us
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Downstream Processing 475 Feed Resi
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Downstream Processing 477 TABLE 2 S
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Downstream Processing 479 Chromatog
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Downstream Processing 481 TABLE 3 S
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Downstream Processing 483 crystalli
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Downstream Processing 485 presents
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Downstream Processing 487 and react
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Downstream Processing 489 The chall
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Downstream Processing 491 Jagschies
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Downstream Processing 493 Zhou JX,
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496 Dosmar and Pinto Pore size (mic
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498 Dosmar and Pinto Flux (ml/min/c
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500 Dosmar and Pinto APPLICATIONS I
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502 Dosmar and Pinto In instances w
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504 Dosmar and Pinto TABLE 1 The Th
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506 Dosmar and Pinto 40% respective
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508 Dosmar and Pinto The polysulfon
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510 Dosmar and Pinto 0.4 0.3 0.2 0.
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512 Dosmar and Pinto Flux (mL/min/c
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514 Dosmar and Pinto interface. The
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516 Dosmar and Pinto Permeate port
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518 Dosmar and Pinto layer is on th
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520 Dosmar and Pinto TABLE 4 Factor
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522 Dosmar and Pinto If the tempera
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524 Dosmar and Pinto Excessive TMP
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526 Dosmar and Pinto Permeate Flow
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528 Dosmar and Pinto rate, identify
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530 Dosmar and Pinto shown) at any
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532 Dosmar and Pinto TABLE 6 Casset
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534 Dosmar and Pinto to the feed ta
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536 Dosmar and Pinto TABLE 8 Biolog
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538 Dosmar and Pinto TABLE Adsorpti
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540 Dosmar and Pinto MWCO Abbreviat
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542 Dosmar and Pinto Marshall AD, M
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544 Aranha were directed at selecti
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546 Aranha CONTROL OF PRODUCTION PR
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548 Aranha There are several availa
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550 Aranha TABLE 4 Risk Minimizatio
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552 Aranha proteins from chromatogr
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554 Aranha side of the filter is ta
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556 Aranha If the size of the prote
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558 Aranha Regulatory guidelines (C
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560 Aranha vary depending on the un
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562 Aranha the virus, it cannot be
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564 Aranha Steps that require dilut
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566 Aranha TABLE 10 Categorization
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568 Aranha TABLE 12 Main Characteri
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570 Aranha rederivatization. CBER h
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572 Aranha also virus removal filte
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574 Aranha every single reported ca
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576 Aranha Golker CF, Whiteman MD,
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21 A Rapid Method for Purifying Esc
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A Rapid Method for Purifying Escher
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22 Membrane Chromatography Jeffrey
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Membrane Chromatography 599 contami
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Membrane Chromatography 601 the cyl
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Membrane Chromatography 603 Even so
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Membrane Chromatography 605 TABLE 2
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Membrane Chromatography 609 Isoelec
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Membrane Chromatography 611 validat
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Membrane Chromatography 613 C/CO 1
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Membrane Chromatography 617 spiked
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23 Expanded Polytetrafluoroethylene
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Expanded Polytetrafluoroethylene Me
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24 Air Filtration Applications in t
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Air Filtration Applications in the
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25 Sterility Testing by Filtration
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Sterility Testing by Filtration in
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700 Mittelman phospholipids surroun
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702 Mittelman 1. Trace organics, wh
Page 729 and 730:
704 Mittelman from chemical treatme
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706 Mittelman Flow Effects In the s
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708 Mittelman TREATMENT Inactivatio
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710 Mittelman TABLE 3 Chemical Trea
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712 Mittelman Khoury AE, Lam K, Ell
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714 Mittelman Richards GK, Gagnon R
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27 Steam Sterilization of Filters S
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Steam Sterilization of Filters 719
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754 Manfredi TABLE 1 List of Organo
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756 Manfredi Based upon its unstabl
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758 Manfredi Ozone, unlike chlorine
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760 Manfredi FIGURE 3 Tubular coron
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762 Manfredi Ozone monitors, for bo
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764 Manfredi ultraviolet decomposit
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766 Manfredi entering the vessel ma
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768 Manfredi d[O 3] = dt k o3 [M] [
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770 Manfredi pressure, although the
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772 Manfredi Ozone. 9 September 200
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774 Index [Air filtration applicati
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776 Index [Charge-modified filters]
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778 Index [ePTFE] lyophilization, 6
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780 Index [Filter validation/filter
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782 Index [Integrity tests] redunda
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784 Index Optimum TMP, definition,
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786 Index [Product capture/purifica
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788 Index [Steam sterilization of f
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790 Index Wetted membrane, rate of
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