PMID- 34684031
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20211026
IS  - 1999-4923 (Print)
IS  - 1999-4923 (Electronic)
IS  - 1999-4923 (Linking)
VI  - 13
IP  - 10
DP  - 2021 Oct 19
TI  - Lessons Learned in Protein Precipitation Using a Membrane Emulsification 
      Technique to Produce Reversible and Uniform Microbeads.
LID - 10.3390/pharmaceutics13101738 [doi]
LID - 1738
AB  - The effects of the manufacturing process and the regeneration of Shirasu porous 
      glass (SPG) membranes were investigated on the reproducibility of protein 
      precipitants, termed protein microbeads. Intravenous immunoglobulin (IVIG) was 
      selected as a model protein to produce its microbeads in seven different cases. 
      The results showed that the hydrophobically modified SPG membrane produced finer 
      microbeads than the hydrophilic SPG membrane, but this was inconsistent when 
      using the general regeneration method. Its reproducibility was determined to be 
      mostly dependent on rinsing the SPG membrane prior to the modification and on the 
      protein concentration used for emulsification. The higher concentration could 
      foul and plug the membrane during protein release and thus the membrane must be 
      washed thoroughly before hydrophobic modification. Moreover, the membrane 
      regenerated by silicone resin dissolved in ethanol had better reproducibility 
      than silicone resin dissolved in water. On the other hand, rinsing the protein 
      precipitant with cold ethanol after the emulsification was not favorable and 
      induced protein aggregation. With the addition of trehalose, the purity of the 
      IVIG microbeads was almost the same as before microbeadification. Therefore, the 
      regeneration method, protein concentration, and its stabilizer are key to the 
      success of protein emulsification and precipitation using the SPG membrane.
FAU - Park, Sang-Koo
AU  - Park SK
AD  - BK21 FOUR Team and Integrated Research Institute for Drug Development, College of 
      Pharmacy, Dongguk University, Seoul 10326, Korea.
FAU - Noh, Ga Yeon
AU  - Noh GY
AD  - BK21 FOUR Team and Integrated Research Institute for Drug Development, College of 
      Pharmacy, Dongguk University, Seoul 10326, Korea.
FAU - Yu, Hyun Woo
AU  - Yu HW
AD  - BK21 FOUR Team and Integrated Research Institute for Drug Development, College of 
      Pharmacy, Dongguk University, Seoul 10326, Korea.
FAU - Lee, Eun Chae
AU  - Lee EC
AD  - BK21 FOUR Team and Integrated Research Institute for Drug Development, College of 
      Pharmacy, Dongguk University, Seoul 10326, Korea.
FAU - Jeong, Junoh
AU  - Jeong J
AD  - BK21 FOUR Team and Integrated Research Institute for Drug Development, College of 
      Pharmacy, Dongguk University, Seoul 10326, Korea.
FAU - Park, Young-Min
AU  - Park YM
AUID- ORCID: 0000-0002-8297-7995
AD  - Division of Health and Kinesiology, Incheon National University, Incheon 22012, 
      Korea.
FAU - Han, Hyo-Kyung
AU  - Han HK
AD  - BK21 FOUR Team and Integrated Research Institute for Drug Development, College of 
      Pharmacy, Dongguk University, Seoul 10326, Korea.
FAU - Jeong, Seong Hoon
AU  - Jeong SH
AD  - BK21 FOUR Team and Integrated Research Institute for Drug Development, College of 
      Pharmacy, Dongguk University, Seoul 10326, Korea.
FAU - Kim, Nam Ah
AU  - Kim NA
AUID- ORCID: 0000-0002-1970-6877
AD  - BK21 FOUR Team and Integrated Research Institute for Drug Development, College of 
      Pharmacy, Dongguk University, Seoul 10326, Korea.
LA  - eng
GR  - NRF-2019R1A2C1083911/National Research Foundation of Korea/
GR  - NRF-2020R1I1A1A01052333/National Research Foundation of Korea/
GR  - 20000265/Ministry of Trade, Industry and Energy/
PT  - Journal Article
DEP - 20211019
PL  - Switzerland
TA  - Pharmaceutics
JT  - Pharmaceutics
JID - 101534003
PMC - PMC8540039
OTO - NOTNLM
OT  - SPG membrane
OT  - intravenous IgG (IVIG)
OT  - membrane emulsification
OT  - microbead
OT  - protein aggregation
OT  - protein stability
OT  - trehalose
COIS- The authors declare no conflict of interest.
EDAT- 2021/10/24 06:00
MHDA- 2021/10/24 06:01
PMCR- 2021/10/19
CRDT- 2021/10/23 01:17
PHST- 2021/09/03 00:00 [received]
PHST- 2021/10/08 00:00 [revised]
PHST- 2021/10/16 00:00 [accepted]
PHST- 2021/10/23 01:17 [entrez]
PHST- 2021/10/24 06:00 [pubmed]
PHST- 2021/10/24 06:01 [medline]
PHST- 2021/10/19 00:00 [pmc-release]
AID - pharmaceutics13101738 [pii]
AID - pharmaceutics-13-01738 [pii]
AID - 10.3390/pharmaceutics13101738 [doi]
PST - epublish
SO  - Pharmaceutics. 2021 Oct 19;13(10):1738. doi: 10.3390/pharmaceutics13101738.