PMID- 33713883
OWN - NLM
STAT- MEDLINE
DCOM- 20210617
LR  - 20210617
IS  - 1873-264X (Electronic)
IS  - 0731-7085 (Linking)
VI  - 198
DP  - 2021 May 10
TI  - PAT solutions to monitor adsorption of Tetanus Toxoid with aluminum adjuvants.
PG  - 114013
LID - S0731-7085(21)00125-4 [pii]
LID - 10.1016/j.jpba.2021.114013 [doi]
AB  - The focus of this study was to examine the small-scale adsorption process of 
      Tetanus Toxoid (TT) as a model protein antigen to aluminum phosphate (AlPO(4)) 
      and aluminum oxyhydroxide (AlOOH) adjuvants with real-time monitoring by in-line 
      ReactIR, ParticleTrack based on Focused Beam Reflectance Measurement (FBRM) and 
      EasyViewer probes. The adsorption process of AlPO(4) and AlOOH with TT using was 
      monitored in the small-scale reactors. Conformational changes in TT were 
      monitored using in-line infrared probe ReactIR, whereas particle formation 
      associated with protein adsorption were measured by particle size, count, and 
      imaging tools, such as ParticleTrack with FBRM and EasyViewer probes. 
      ParticleTrack distribution results and kinetic measurements were also supported 
      by observations made using EasyViewer. In addition to EasyMax, BioBLU reactor was 
      also used for the adsorption experiments. ReactIR with ATR-Fiber probe was 
      effectively able to monitor adsorption progress of TT to AlOOH and to AlPO(4). 
      ReactIR, EasyViewer, and ParticleTrack provided detailed mechanistic and kinetic 
      information for reaction of TT with AlPO(4) and AlOOH. These in-situ measurements 
      revealed a possible multi-step process for TT to AlPO(4) which may be an 
      indication of antigen adsorption.
CI  - Copyright (c) 2021 The Author(s). Published by Elsevier B.V. All rights reserved.
FAU - Haer, Manjit
AU  - Haer M
AD  - Analytical Sciences, Sanofi Pasteur, Toronto, Canada.
FAU - Strahlendorf, Kirsten
AU  - Strahlendorf K
AD  - Bioprocess Research and Development, Sanofi Pasteur, Toronto, Canada.
FAU - Payne, Jessie
AU  - Payne J
AD  - Analytical Sciences, Sanofi Pasteur, Toronto, Canada.
FAU - Jung, Ryan
AU  - Jung R
AD  - Bioprocess Research and Development, Sanofi Pasteur, Toronto, Canada.
FAU - Xiao, Emily
AU  - Xiao E
AD  - Bioprocess Research and Development, Sanofi Pasteur, Toronto, Canada.
FAU - Mirabel, Clementine
AU  - Mirabel C
AD  - Bioprocess Research and Development, Sanofi Pasteur, Toronto, Canada.
FAU - Rahman, Nausheen
AU  - Rahman N
AD  - Bioprocess Research and Development, Sanofi Pasteur, Toronto, Canada.
FAU - Kowal, Przemek
AU  - Kowal P
AD  - Analytical Sciences, Sanofi Pasteur, Toronto, Canada.
FAU - Gemmiti, Gabriel
AU  - Gemmiti G
AD  - Manufacturing Technology, Sanofi Pasteur, Toronto, Canada.
FAU - Cronin, James T
AU  - Cronin JT
AD  - Mettler Toledo AutoChem Inc., Columbia, MD, USA.
FAU - Gable, Tyler
AU  - Gable T
AD  - Mettler Toledo AutoChem Inc., Columbia, MD, USA.
FAU - Park-Lee, Kevin
AU  - Park-Lee K
AD  - Mettler Toledo AutoChem Inc., Columbia, MD, USA.
FAU - Drolet-Vives, Katherine
AU  - Drolet-Vives K
AD  - Mettler Toledo AutoChem Inc., Montreal, QC, Canada.
FAU - Balmer, Matthew
AU  - Balmer M
AD  - Analytical Sciences, Sanofi Pasteur, Swiftwater, USA.
FAU - Kirkitadze, Marina
AU  - Kirkitadze M
AD  - Analytical Sciences, Sanofi Pasteur, Toronto, Canada. Electronic address: 
      Marina.Kirkitadze@sanofi.com.
LA  - eng
PT  - Journal Article
DEP - 20210306
PL  - England
TA  - J Pharm Biomed Anal
JT  - Journal of pharmaceutical and biomedical analysis
JID - 8309336
RN  - 0 (Adjuvants, Immunologic)
RN  - 0 (Tetanus Toxoid)
RN  - CPD4NFA903 (Aluminum)
SB  - IM
MH  - *Adjuvants, Immunologic
MH  - Adsorption
MH  - *Aluminum
MH  - Particle Size
MH  - Tetanus Toxoid
OTO - NOTNLM
OT  - AlOOH
OT  - AlPO(4)
OT  - Aluminum adjuvants
OT  - BioBLU
OT  - FBRM
OT  - FTIR
OT  - Process Analytical Technology (PAT)
OT  - Single-use bioprocessing technology
OT  - Tetanus Toxoid (TT)
COIS- Declaration of Competing Interest The authors report no declarations of interest.
EDAT- 2021/03/14 06:00
MHDA- 2021/06/22 06:00
CRDT- 2021/03/13 20:16
PHST- 2021/02/05 00:00 [received]
PHST- 2021/03/03 00:00 [revised]
PHST- 2021/03/04 00:00 [accepted]
PHST- 2021/03/14 06:00 [pubmed]
PHST- 2021/06/22 06:00 [medline]
PHST- 2021/03/13 20:16 [entrez]
AID - S0731-7085(21)00125-4 [pii]
AID - 10.1016/j.jpba.2021.114013 [doi]
PST - ppublish
SO  - J Pharm Biomed Anal. 2021 May 10;198:114013. doi: 10.1016/j.jpba.2021.114013. 
      Epub 2021 Mar 6.