Membrane Filtration

Brose, Daniel J.; Dosmar, M; Jornitz, Maik W.

doi:10.1007/978-1-4615-0549-5_5

Cited by 7 publications

(5 citation statements)

References 12 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Most proprietary Chinese medicines are compound agents containing a variety of substances with complex components, which have bacteriostatic efficacy leading to a decrease in accuracy of the microbial limit test [ 2 , 3 ]. Therefore, the study on the applicability of the microbial limit test for children's proprietary Chinese medicines not only ensures the integrity and accuracy of the test method, but also provides theoretical support for its safe use to a certain extent [ 4 , 5 ]. 10 proprietary Chinese medicines, including Xiao'er Ganmao granule, Xiao'er Jiegan granule, Xiao'er Huatan Zhike granule, Xiao'er Feire Kechuan granule, Xiao'er Chaigui Tuire granule, Xiao'er Chiqiao Qingre granule, Xiao'er Yanbian granule, Jinlian Qingre granule, Kanggan granule, and An'erning granule, with different antibacterial components, are commonly given to children for cold [ 6 , 7 ].…”

Section: Introductionmentioning

confidence: 99%

Microorganism Determination of 10 Proprietary Chinese Medicines for Children by Plate Culture or Membrane Filtration

Hong

Jia

Yuan

2022

Evidence-Based Complementary and Alternative Medicine

View full text Add to dashboard Cite

Objective. This study attempted to verify the applicability of the microbial limit test (plate culture and membrane filtration) for 10 proprietary Chinese medicines for children. Methods. In this study, we collected 10 proprietary Chinese medicines for children as study objects and performed plate culture and membrane filtration to calculate the colony-forming unit (cfu) of microorganisms in these medicines and verify its applicability in objectionable microorganisms. Results. It was found that the recovery rate of microorganisms including Staphylococcus aureus, Bacillus subtilis, Pseudomonas aeruginosa, Candida albicans, and Aspergillus niger ranged from 70% to 150%. This verification was performed by plate culture or membrane filtration. Inspection for objectionable microorganisms (Escherichia coli, Salmonella paratyphi B, and bile salt-tolerant Gram-negative bacteria) was applicable for most medicines. Conclusion. Microbial limit test is feasible for the determination of microorganisms in 10 proprietary Chinese medicines for children.

show abstract

Section: Introductionmentioning

confidence: 99%

Microorganism Determination of 10 Proprietary Chinese Medicines for Children by Plate Culture or Membrane Filtration

Hong

Jia

Yuan

2022

Evidence-Based Complementary and Alternative Medicine

View full text Add to dashboard Cite

show abstract

“…In some cases, the initial investment in MF systems can be comparatively high, and the technology may not be appropriate for applications demanding the separation of very small molecules. 57,58 Zhu et al reported utilizing membrane ultraltration to collect the fraction of laminarin. 59…”

Section: Purication Of Algal Polysaccharidesmentioning

confidence: 99%

From algae to advancements: laminarin in biomedicine

Pramanik,

Singh,

Abualsoud

et al. 2024

RSC Adv.

View full text Add to dashboard Cite

show abstract

“…[13][14][15] In a TFF operation, the sample solution (load) flows tangent to the surface of the membrane where molecules smaller than the membrane pore size or molecular weight cut-off (MWCO) remain in the fluid that passes through the membrane (permeate) while molecules that are larger in relation to the cut-off of the membrane are accordingly retained (retentate) and recirculated back to the load reservoir. 13 This allows UF/DF to separate small molecules from the biopharmaceutical products and the buffer exchange step in the diafiltration process clearing any small molecule and elemental entities. 16 Several studies showed successes of UF/DF in clearing small molecules from recombinant proteins.…”

Section: Introductionmentioning

confidence: 99%

“…Various downstream processing steps have been shown to attenuate leachables risk, particularly ultrafiltration/diafiltration (UF/DF) via tangential flow filtration (TFF) operation, which is widely used as the final purification step prior to the final sterile filtration and/or formulation and filling step 13–15 . In a TFF operation, the sample solution (load) flows tangent to the surface of the membrane where molecules smaller than the membrane pore size or molecular weight cut‐off (MWCO) remain in the fluid that passes through the membrane (permeate) while molecules that are larger in relation to the cut‐off of the membrane are accordingly retained (retentate) and recirculated back to the load reservoir 13 . This allows UF/DF to separate small molecules from the biopharmaceutical products and the buffer exchange step in the diafiltration process clearing any small molecule and elemental entities 16 .…”

Section: Introductionmentioning

confidence: 99%

Efficiency of ultrafiltration/diafiltration in removing organic and elemental process equipment related leachables from biological therapeutics

Sun,

Hadidi,

Santiago Nuñez

et al. 2023

Biotechnology Progress

View full text Add to dashboard Cite

In the production of biological therapeutics such as monoclonal antibodies (mAbs), ultrafiltration and diafiltration (UF/DF) are widely regarded as effective downstream processing steps capable of removing process equipment related leachables (PERLs) introduced upstream of the UF/DF step. However, clearance data available in the literature are limited to species with low partition coefficients (log P) such as buffer ions, hydrophilic organic compounds, and some metal ions. Additional data for a wide range of PERLs including hydrophobic compounds and elemental impurities are needed to establish meaningful, comprehensive safety risk assessments. Herein, we report the results from studies investigating the clearance of seven different organic PERLs representing a wide range of characteristics (i.e., log P (−0.3 to 18)), and four model elements with different chemical properties spiked into a mAb formulation at 10 ppm and analyzed during clearance using gas chromatography–mass spectrometry (GC–MS), liquid chromatography‐photodiode‐array‐mass spectrometry (LC‐PDA‐MS), and inductively coupled plasma mass spectrometry (ICP‐MS). The clearance data showed ideal clearance and sieving of spiked organic PERLs with log P < 4, partial clearance of PERLs with 4 < log P < 9, and poor clearance of highly hydrophobic PERLs (log P > 9) after nine diafiltration volumes (DVs). Supplemental clearance studies on seven additional PERLs present at much lower concentration levels (0.1–1.5 ppm) in the mAb formulation upstream of UF/DF and three PERLs associated with the tangential flow filtration (TFF) equipment also demonstrated the similar correlations between log P and % clearance. For model elements, the findings suggest that UF/DF in general provides ideal clearance for elements. Evidence showed that the UF/DF process does not only help mitigate leachables risk from PERLs introduced upstream of UF/DF, but also from the TFF operation itself as all three TFF‐related PERLs were effectively cleared. Overall, the UF/DF clearance presented in this work demonstrated whereas highly hydrophobic PERLs and elements that exist as charged species, particularly transition metal ions, may not be as effectively cleared and thus warrant further risk assessment; hydrophilic and some hydrophobic PERLs (log P < 4) are indeed well‐cleared and thus present a lower overall safety risk.

show abstract

Membrane Filtration

Cited by 7 publications

References 12 publications

Microorganism Determination of 10 Proprietary Chinese Medicines for Children by Plate Culture or Membrane Filtration

Microorganism Determination of 10 Proprietary Chinese Medicines for Children by Plate Culture or Membrane Filtration

From algae to advancements: laminarin in biomedicine

Efficiency of ultrafiltration/diafiltration in removing organic and elemental process equipment related leachables from biological therapeutics

Contact Info

Product

Resources

About