Bibliography
Adams, B., H. Bak and A. D. Tustian
(2020). ”Moving from the bench towards a large scale, industrial
platform process for adeno-associated viral vector purification.”117 (10): 3199-3211.
Arnold, L., K. Lee, J. Rucker-Pezzini
and J. H. Lee (2019). ”Implementation of Fully Integrated Continuous
Antibody Processing: Effects on Productivity and COGm.” 14 (2):
1800061.
Asper, M., T. Hanrieder, A. Quellmalz
and A. Mihranyan (2015). ”Removal of xenotropic murine leukemia virus by
nanocellulose based filter paper.” Biologicals 43 (6):
452-456.
Barone, P. W., M. E. Wiebe, J. C.
Leung, I. T. M. Hussein, F. J. Keumurian, J. Bouressa, A. Brussel, D.
Chen, M. Chong, H. Dehghani, L. Gerentes, J. Gilbert, D. Gold, R. Kiss,
T. R. Kreil, R. Labatut, Y. Li, J. Müllberg, L. Mallet, C. Menzel, M.
Moody, S. Monpoeho, M. Murphy, M. Plavsic, N. J. Roth, D. Roush, M.
Ruffing, R. Schicho, R. Snyder, D. Stark, C. Zhang, J. Wolfrum, A. J.
Sinskey and S. L. Springs (2020). ”Viral contamination in biologic
manufacture and implications for emerging therapies.” Nature
Biotechnology 38 (5): 563-572.
Bartels, J., A. G. Batista, S. Kroll,
M. Maas and K. Rezwan (2019). ”Hydrophobic ceramic capillary membranes
for versatile virus filtration.” Journal of Membrane Science570-571 : 85-92.
Bolton, G., M. Cabatingan, M. Rubino,
S. Lute, K. Brorson and M. Bailey (2005). ”Normal‐flow virus filtration:
detection and assessment of the endpoint in bioprocessing.”Biotechnology and applied biochemistry 42 (2): 133-142.
Bolton, G., J. Cormier, M. Krishnan,
J. Lewnard and H. Lutz (2006). ”Integrity testing of normal flow
parvovirus filters using air-liquid based tests.” Bioprocessing
Journal 5 (1): 50.
Bolton, G. R., S. Spector and D.
LaCasse (2006). ”Increasing the capacity of parvovirus‐retentive
membranes: performance of the Viresolve™ Prefilter.” Biotechnology
and applied biochemistry 43 (1): 55-63.
Brorson, K., S. Krejci, K. Lee, E.
Hamilton, K. Stein and Y. Xu (2003). ”Bracketed generic inactivation of
rodent retroviruses by low pH treatment for monoclonal antibodies and
recombinant proteins.” 82 (3): 321-329.
Brorson, K., G. Miesegaes, O.
Tounekti, J. Skene and J. Blumel (2014). ”Conference Summary: Gaps,
Lessons Learned, and Areas for Improvement.” PDA Journal of
Pharmaceutical Science and Technology 68 (1): 83-89.
Brown, A., C. Bechtel, J. Bill, H.
Liu, J. Liu, D. McDonald, S. Pai, A. Radhamohan, R. Renslow, B. Thayer,
S. Yohe and C. Dowd (2010). ”Increasing parvovirus filter throughput of
monoclonal antibodies using ion exchange membrane adsorptive
pre-filtration.” 106 (4): 627-637.
Brown, M. R., M. S. Burnham, S. A.
Johnson, S. C. Lute, K. A. Brorson and D. J. Roush (2018). ”Evaluating
the effect of in-process material on the binding mechanisms of surrogate
viral particles to a multi-modal anion exchange resin.” J
Biotechnol 267 : 29-35.
Brown, M. R., M. S. Burnham, S. C.
Lute, S. A. Johnson, A. A. Walsh, K. A. Brorson and D. J. Roush (2018).
”Defining the mechanistic binding of viral particles to a multi-modal
anion exchange resin.” Biotechnol Prog 34 (4): 1019-1026.
Brown, M. R., S. A. Johnson, K. A.
Brorson, S. C. Lute and D. J. Roush (2017). ”A step-wise approach to
define binding mechanisms of surrogate viral particles to multi-modal
anion exchange resin in a single solute system.” 114 (7):
1487-1494.
Carbrello, C., J. Perreault, D.
Nhiem, T. Greenhalgh, M. Priest, A. Leahy, D. DeCesaro, N. Nyugen, K.
Mann, M. McGlothlen, J. Broe, J. Orlando, K. Cunningham, Y. Zeng and K.
Rautio (2017). ”Upstream Virus Safety: Protect Your Bioreactor By Media
Filtration.” MilliporeSigma, Bedford MA USA .
Chen, D. (2014). ”Viral Clearance
Using Traditional, Well-Understood Unit Operations (Session I):
Virus-Retentive Filtration.” 68 (1): 38-50.
Chen, Q. and D. Chen (2015). ”Viral
clearance of traditional unit operations: virus-retentive filtration.”PDA J Pharm Sci Technol 69 (1): 142-153.
David, L., B. Maiser, M. Lobedann, P.
Schwan, M. Lasse, H. Ruppach and G. Schembecker (2019). ”Virus study for
continuous low pH viral inactivation inside a coiled flow inverter.”116 (4): 857-869.
De Vilmorin, P., A. Slocum, T. Jaber,
O. Schaefer, H. Ruppach and P. Genest (2015). ”Achieving a Successful
Scale-Down Model and Optimized Economics through Parvovirus Filter
Validation using Purified
TrueSpike<sup>TM</sup>
Viruses.” 69 (3): 440-449.
DiLeo, A. J., A. E. Allegrezza and S.
E. Builder (1992). ”High Resolution Removal of Virus from Protein
Solutions Using a Membrane of Unique Structure.” Bio/Technology10 (2): 182-188.
Dishari, S. K., M. R. Micklin, K. J.
Sung, A. L. Zydney, A. Venkiteshwaran and J. N. Earley (2015). ”Effects
of solution conditions on virus retention by the Viresolve® NFP filter.”Biotechnol Prog 31 (5): 1280-1286.
EMEA (1996). ”Note for Guidance on
Virus Validation Studies: The Design, Contriubtion and Interpretation of
Studies Validating the Inactivation and Removal of Viruses.”CMPM/BWP/268/95 .
Fallahianbijan, F., S. Giglia, C.
Carbrello and A. L. Zydney (2017). ”Use of fluorescently-labeled
nanoparticles to study pore morphology and virus capture in virus
filtration membranes.” Journal of Membrane Science 536 :
52-58.
Fan, R., F. Namila, D. Sansongko, S.
R. Wickramasinghe, M. Jin, D. Kanani and X. Qian ”The effects of flux on
the clearance of minute virus of mice during constant flux virus
filtration.” n/a (n/a).
Gefroh, E., H. Dehghani, M. McClure,
L. Connell-Crowley and G. Vedantham (2014). ”Use of MMV as a Single
Worst-Case Model Virus in Viral Filter Validation Studies.” PDA J
Pharm Sci Technol 68 (3): 297-311.
Gefroh, E., A. Hewig, G. Vedantham,
M. McClure, A. Krivosheyeva, A. Lajmi and Y. Lu (2013). ”Multipronged
approach to managing beta-glucan contaminants in the downstream process:
Control of raw materials and filtration with charge-modified nylon 6,6
membrane filters.” 29 (3): 672-680.
Giglia, S., J. Caulmare, D. Nhiem and
D. Porreca (2016). ”Air-water binary gas integrity test for sterilizing
and virus filters.” pdajpst.2016.006437.
Gustafsson, O., S. Gustafsson, L.
Manukyan and A. Mihranyan (2018). ”Significance of Brownian Motion for
Nanoparticle and Virus Capture in Nanocellulose-Based Filter Paper.”8 (4): 90.
Gustafsson, S., P. Lordat, T.
Hanrieder, M. Asper, O. Schaefer and A. Mihranyan (2016). ”Mille-feuille
paper: a novel type of filter architecture for advanced virus separation
applications.” Materials Horizons 3 (4): 320-327.
Gustafsson, S. and A. Mihranyan
(2016). ”Strategies for Tailoring the Pore-Size Distribution of Virus
Retention Filter Papers.” ACS Applied Materials & Interfaces8 (22): 13759-13767.
Gustafsson, S. and A. Mihranyan
(2017). ”Investigating Protein Throughput, Vmax Values and Virus Removal
Efficiency of the Paper Based Mille-Feuille Filter.” 253rd
National Meeting of the American-Chemical-Society (ACS) on Advanced
Materials, Technologies, Systems, and Processes, San Francisco, CA,
April 02-06, 2017 253 .
Holstein, M., D. Jang, C. Urrea, L.
S. Botta, W. Grimm, S. Ghose and Z. J. Li (2021). ”Control of leached
beta-glucan levels from depth filters by an improved depth filtration
flush strategy.” 37 (1): e3086.
Hongo-Hirasaki, T., M. Komuro and S.
Ide (2010). ”Effect of antibody solution conditions on filter
performance for virus removal filter Planova™ 20N.” 26 (4):
1080-1087.
ICH (1998). ”International Conference
on Harmonisation; guidance on viral safety evaluation of biotechnology
products derived from cell lines of human or animal origin;
availability–FDA. Notice.” Fed Regist 63 (185):
51074-51084.
Johnson, S. A., M. R. Brown, S. C.
Lute and K. A. Brorson (2017). ”Adapting viral safety assurance
strategies to continuous processing of biological products.”114 (1): 21-32.
Johnson, S. A. and D. Roush (2018).
”Proceedings of the 2017 Viral Clearance Symposium, Session 6: Ensuring
Viral Safety in Continuous Processing.” 72 (5): 516-524.
Junter, G.-A. and L. Lebrun (2017).
”Cellulose-based virus-retentive filters: a review.” Reviews in
Environmental Science and Bio/Technology 16 (3): 455-489.
Khan, N. Z., J. J. Parrella, P. W.
Genest and M. S. Colman (2009). ”Filter preconditioning enables
representative scaled-down modelling of filter capacity and viral
clearance by mitigating the impact of virus spike impurities.”Biotechnol Appl Biochem 52 (Pt 4): 293-301.
Khanal, O., N. Singh, S. J. Traylor,
X. Xu, S. Ghose, Z. J. Li and A. M. Lenhoff (2018). ”Contributions of
depth filter components to protein adsorption in bioprocessing.”115 (8): 1938-1948.
Kleindienst, B. and A. Manzke (2016).
”Virus Risk Mitigation in Cell Culture Media.” BioPharm
International 29 (10)
Kreil, T. R. and D. Roush (2018).
”Proceedings of the 2017 Viral Clearance Symposium, Session 2.1: DSP
Unit Operations—Virus Filtration/Inactivation.” PDA Journal of
Pharmaceutical Science and Technology 72 (5): 470-478.
LaCasse, D., S. Lute, M. Fiadeiro, J.
Basha, M. Stork, K. Brorson, R. Godavarti and C. Gallo (2016).
”Mechanistic failure mode investigation and resolution of parvovirus
retentive filters.” Biotechnol Prog 32 (4): 959-970.
Lefkowitz, E. J., D. M. Dempsey, R.
C. Hendrickson, R. J. Orton, S. G. Siddell and D. B. Smith (2017).
”Virus taxonomy: the database of the International Committee on Taxonomy
of Viruses (ICTV).” Nucleic Acids Research 46 (D1):
D708-D717.
Liu, S., M. Carroll, R. Iverson, C.
Valera, J. Vennari, K. Turco, R. Piper, R. Kiss and H. Lutz (2000).
”Development and Qualification of a Novel Virus Removal Filter for Cell
Culture Applications.” Biotechnology Progress 16 (3):
425-434.
Lubiniecki, A. S. (2011). ”Evolution
of Approaches to Viral Safety Issues for Biological Products.”65 (6): 547-556.
Lute, S. (2015). An Update of the FDA
Viral Clearance Database to include Regulatory Submission until 2014.PDA Europe Virus & TSE Safety Forum . Lisbon, Portugal.
Lute, S., M. Bailey, J. Combs, M.
Sukumar and K. Brorson (2007). ”Phage passage after extended processing
in small-virus-retentive filters.” Biotechnol Appl Biochem47 (Pt 3): 141-151.
Lute, S., K. Brorson, M. Cabatingan,
T. Saravara, G. Bolton, D. LaCasse, J. Carter, M. Sukomar, J. Combs and
M. Bailey (2005). Enterobacteriophage Phi X174 clearance versus
flow decay in NFP virus filters . ABSTRACTS OF PAPERS OF THE AMERICAN
CHEMICAL SOCIETY, AMER CHEMICAL SOC 1155 16TH ST, NW, WASHINGTON, DC
20036 USA.
Lute, S., J. Kozaili, S. Johnson, K.
Kobayashi and D. Strauss (2020). ”Development of small-scale models to
understand the impact of continuous downstream bioprocessing on
integrated virus filtration.” 36 (3): e2962.
Lute, S., W. Riordan, L. F. Pease,
D.-H. Tsai, R. Levy, M. Haque, J. Martin, I. Moroe, T. Sato, M. Morgan,
M. Krishnan, J. Campbell, P. Genest, S. Dolan, K. Tarrach, A. Meyer, M.
R. Zachariah, M. J. Tarlov, M. Etzel and K. Brorson (2008). ”A Consensus
Rating Method for Small Virus-Retentive Filters. I. Method Development.”62 (5): 318-333.
Lutz, H., W. Chang, T. Blandl, G.
Ramsey, J. Parella, J. Fisher and E. Gefroh (2011). ”Qualification of a
novel inline spiking method for virus filter validation.”27 (1): 121-128.
Manukyan, L., P. Li, S. Gustafsson
and A. Mihranyan (2019). ”Growth media filtration using
nanocellulose-based virus removal filter for upstream biopharmaceutical
processing.” Journal of Membrane Science 572 : 464-474.
Manukyan, L., J. Padova and A.
Mihranyan (2019). ”Virus removal filtration of chemically defined
Chinese Hamster Ovary cells medium with nanocellulose-based size
exclusion filter.” Biologicals 59 : 62-67.
Marques, B. F., D. J. Roush and K. E.
Göklen (2009). ”Virus filtration of high-concentration monoclonal
antibody solutions.” Biotechnol Prog 25 (2): 483-491.
Mattila, J., M. Clark, S. Liu, J.
Pieracci, T. R. Gervais, E. Wilson, O. Galperina, X. Li, D. Roush, K.
Zoeller, H. Brough and C. Simpson-Platre (2016). ”Retrospective
Evaluation of Low-pH Viral Inactivation and Viral Filtration Data from a
Multiple Company Collaboration.” PDA J Pharm Sci Technol70 (3): 293-299.
MerckMillipore (2017).
”Viresolve®Barrier Filters.” Lit No. DS1401EN00 Ver. 1.0
2016-00378 12/2017 .
Metreveli, G., L. Wågberg, E. Emmoth,
S. Belák, M. Strømme and A. Mihranyan (2014). ”A Size-Exclusion
Nanocellulose Filter Paper for Virus Removal.” 3 (10):
1546-1550.
Miesegaes, G., S. Lute and K. Brorson
(2010). ”Analysis of viral clearance unit operations for monoclonal
antibodies.” Biotechnology and Bioengineering 106 (2):
238-246.
Nguyen, H. C., A. L. Langland, J. P.
Amara, M. Dullen, D. S. Kahn and J. A. Costanzo (2019). ”Improved HCP
Reduction Using a New, All-Synthetic Depth Filtration Media Within an
Antibody Purification Process.” 14 (1): 1700771.
Nowak, T., B. Popp and N. J. Roth
(2019). ”Choice of parvovirus model for validation studies influences
the interpretation of the effectiveness of a virus filtration step.”Biologicals 60 : 85-92.
Oh, D. J., S. K. Choi and H. N. Chang
(1994). ”High-density continuous cultures of hybridoma cells in a depth
filter perfusion system.” 44 (8): 895-901.
Patt, E., W. Dong and W. Gang (2015).
”Continuous Bioprocessing: Part I, Final Report.” Project
MIT-FDA-15F04 .
PDA (2008). Technical Report
No. 41 Virus Filtration .
PDA (2010). ”Technical Report No. 47
Preparation of Virus Spikes Used for Virus Clearance Studies.”
PDA (2021). PDA Standard
04-2021: Phage Retention Nomenclature Rating for Small- and Large-Virus
Retentive Filters .
Phillips, M. W., G. Bolton, M.
Krishnan, J. J. Lewnard and B. Raghunath (2007). 11 Virus Filtration
Process Design and Implementation. Process Scale Bioseparations
for the Biopharmaceutical Industry : 333.
Riordan, W., K. Brorson, S. Lute and
M. Etzel (2009). ”Examination of the Adsorption of Large Biological
Molecules to Anion Exchange Surfaces Using Surface Plasmon Resonance.”Separation Science and Technology 45 (1): 1-10.
Roth, N. J., H. O. Dichtelmüller, F.
Fabbrizzi, E. Flechsig, A. Gröner, M. Gustafson, J. I. Jorquera, T. R.
Kreil, D. Misztela, E. Moretti, M. Moscardini, G. Poelsler, J. More, P.
Roberts, A. Wieser and R. Gajardo ”Nanofiltration as a robust method
contributing to viral safety of plasma-derived therapeutics: 20 yearsʼ
experience of the plasma protein manufacturers.” n/a (n/a).
Roth, N. J., H. O. Dichtelmüller, F.
Fabbrizzi, E. Flechsig, A. Gröner, M. Gustafson, J. I. Jorquera, T. R.
Kreil, D. Misztela, E. Moretti, M. Moscardini, G. Poelsler, J. More, P.
Roberts, A. Wieser and R. Gajardo (2020). ”Nanofiltration as a robust
method contributing to viral safety of plasma-derived therapeutics:
20 yearsʼ experience of the plasma protein manufacturers.”60 (11): 2661-2674.
Roush, D. and J. Ma (2016). ”Viral
Clearance Using Traditional, Well-Understood Unit Operations Session
1.2: Virus-Retentive Filtration.” PDA J Pharm Sci Technol70 (5): 417-427.
Shethji, J. K., R. M. Dorin and S.
Robbins (2019). Isoporous self-assembled block copolymer films
containing high molecular weight hydrophilic additives and methods of
making the same.
Singh, N., A. Arunkumar, M. Peck, A.
M. Voloshin, A. M. Moreno, Z. Tan, J. Hester, M. C. Borys and Z. J. Li
(2017). ”Development of adsorptive hybrid filters to enable two-step
purification of biologics.” MAbs 9 (2): 350-363.
Slocum, A., M. Burnham, P. Genest, A.
Venkiteshwaran, D. Chen and J. Hughes (2013). ”Impact of virus
preparation quality on parvovirus filter performance.” 110 (1):
229-239.
Soluk, L., H. Price, C. Sinclair, D.
Atalla-Mikhail and M. Genereux (2008). ”Pathogen safety of intravenous
Rh immunoglobulin liquid and other immune globulin products: enhanced
nanofiltration and manufacturing process overview.” Am J Ther15 (5): 435-443.
Stanley, B., V. Holmes, R. Manzari,
C. Romanowski, A. Tessarz, H. Ruppach and J. Schreffler (2021). ”Twenty
Plus Years of Data Demonstrating Virus Filtration as an Effective and
Robust Step for Large Virus Removal.” PDA Journal of
Pharmaceutical Science and Technology In Press .
Strauss, D., J. Goldstein, T.
Hongo-Hirasaki, Y. Yokoyama, N. Hirotomi, T. Miyabayashi and D. Vacante
(2017). ”Characterizing the impact of pressure on virus filtration
processes and establishing design spaces to ensure effective parvovirus
removal.” Biotechnol Prog 33 (5): 1294-1302.
Strauss, D. M., S. Lute, Z.
Tebaykina, D. D. Frey, C. Ho, G. S. Blank, K. Brorson, Q. Chen and B.
Yang (2009). ”Understanding the mechanism of virus removal by Q
sepharose fast flow chromatography during the purification of CHO-cell
derived biotherapeutics.” 104 (2): 371-380.
Stuckey, J., D. Strauss, A.
Venkiteshwaran, J. Gao, W. Luo, M. Quertinmont, S. O’Donnell and D. Chen
(2014). ”A novel approach to achieving modular retrovirus clearance for
a parvovirus filter.” Biotechnol Prog 30 (1): 79-85.
Swalec, J. F., S. Feng and E. Patt
(2015). ”Continuous Bioprocessing: Part II, Final Report.” Project
MIT-FDA-15F04 .
Tang, A., I. Ramos, K. Newell and K.
D. Stewart (2020). ”A novel high-throughput process development
screening tool for virus filtration.” Journal of Membrane Science611 : 118330.
WHO (2004). ”Guidelines on viral
inactivation and removal procedures intended to assure the viral safety
of human blood plasma products.” WHO Technical Report924 .
Wolfgang, M., A. Mitterer, M. Reiter,
M. Hasslacher, L. Grillberger and T. R. Kreil (2013). Virus filtration
of cell culture media.
Wu, H. and D. K. Schwartz (2020).
”Nanoparticle Tracking to Probe Transport in Porous Media.”Accounts of Chemical Research 53 (10): 2130-2139.
Zeytuncu, B., M. Ürper, İ. Koyuncu
and V. V. Tarabara (2018). ”Photo-crosslinked PVA/PEI electrospun
nanofiber membranes: Preparation and preliminary evaluation in virus
clearance tests.” Separation and Purification Technology197 : 432-438.