Application of ethylenediamine monolith to purify a hemagglutinin influenza deoxyribonucleic acid-based vaccine

Bicho, Diana; Santos, Bartolo; Caramelo-Nunes, C.; Sousa, Ângela; Queiroz, João A.; Tomaz, Cândida T.

doi:10.1016/j.seppur.2015.09.046

Cited by 11 publications

(9 citation statements)

References 43 publications

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“…Similar results were described for ethylenediamine monolith also using an increased gradient of NaCl, with a purity level and recovery yield of 97.1% and 47%, respectively [12]. Therefore, our strategy results in similar levels of purity and improved recovery yield of sc NTC 7482-41H-VA2 HA plasmid, compared to other approaches developed for the purification of NTC 7482-41H-VA2 HA vaccine using affinity supports [12].…”

Section: Quantitative Analysis Of Sc Ntc7482-41h-va2 Ha Plasmidsupporting

confidence: 71%

“…Dynamic binding capacity (DBC) of a stationary phase is an important parameter in pDNA purification, as showed in previous studies [12][13][14]. The method consists in measure the amount of pDNA that will bind to the column under certain experimental conditions, before occurrence of a break in breakthrough curve [33].…”

Section: 32-dynamic Binding Capacitymentioning

confidence: 99%

“…The DBC information allows the assessment of loading conditions and column lifetime, avoiding extra process scale-up, processing time, costs and pDNA loss [33,34]. In previous reports, it was showed that pDNA feedstock concentration directly affect DBC [12][13][14]. Therefore, DBC was determined for pHEMA cryogel using native NTC7482-41H-VA2 HA plasmid feedstock concentrations (0.010, 0.05 and 0.100 mg/mL) and 10 mM acetate buffer pH 5.0 (10 mM sodium acetate and acetic acid) as mobile phase at 1 mL/min.…”

Section: 32-dynamic Binding Capacitymentioning

confidence: 99%

“…Recently, several chromatography supports based on ethylenediamine and agmatine monoliths were used to purify a HA influenza deoxyribonucleic acid-based vaccine [12,13]. These monoliths have several advantages over conventional stationary phases, since they present excellent mass transfer properties and flow independence resolution [14].…”

Section: Introductionmentioning

confidence: 99%

See 3 more Smart Citations

Influenza DNA vaccine purification using pHEMA cryogel support

Santos

Brito

Boto

et al. 2018

Separation and Purification Technology

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Section: Quantitative Analysis Of Sc Ntc7482-41h-va2 Ha Plasmidsupporting

confidence: 71%

Section: 32-dynamic Binding Capacitymentioning

confidence: 99%

Section: 32-dynamic Binding Capacitymentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

See 2 more Smart Citations

Influenza DNA vaccine purification using pHEMA cryogel support

Santos

Brito

Boto

et al. 2018

Separation and Purification Technology

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“…Weaker AEC ligands are fortunately known and they offer potential for Separation of Empty and Full Adeno-Associated Virus Capsids from a Weak Anion Exchanger by Elution with an Ascending pH Gradient at Low Ionic Strength elution at more moderate pH values. Examples include primary amines [24,25] ; ligands with combined primary and secondary amine functionalities [26] ; combined primary, secondary, and tertiary amine functionalities [27][28][29][30] ; and ligands combining primary, secondary, tertiary, and QA functionalities [13] .…”

Section: Introductionmentioning

confidence: 99%

Untitled

2021

BPJ

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Separation of empty and full AAV8 capsids was achieved during their elution from a weak anion exchanger with an ascending pH gradient at low conductivity. Experimental data suggest elution was mediated by loss of positive charge from the exchanger. The method produced a full capsid peak with fewer empty capsids than elution of a strong anion exchanger with a salt gradient. Elution of the weak exchanger by sodium chloride gradients or by pH gradients in the presence of sodium chloride gave inferior separation performance. Pre-elution of empty capsids with a pH step allowed full capsids to be eluted by salt without compromising separation. Loading at intermediate pH prevented empty capsid binding and enabled step elution of full capsids in a physiological buffer environment.

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Current technologies to endotoxin detection and removal for biopharmaceutical purification

Schneier

Razdan

Miller

et al. 2020

Biotech & Bioengineering

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Endotoxins are the major contributors to the pyrogenic response caused by contaminated pharmaceutical products, formulation ingredients, and medical devices. Recombinant biopharmaceutical products are manufactured using living organisms, including Gram‐negative bacteria. Upon the death of a Gram‐negative bacterium, endotoxins (also known as lipopolysaccharides) in the outer cell membrane are released into the lysate where they can interact with and form bonds with biomolecules, including target therapeutic compounds. Endotoxin contamination of biologic products may also occur through water, raw materials such as excipients, media, additives, sera, equipment, containers closure systems, and expression systems used in manufacturing. The manufacturing process is, therefore, in critical need of methods to reduce and remove endotoxins by monitoring raw materials and in‐process intermediates at critical steps, in addition to final drug product release testing. This review paper highlights a discussion on three major topics about endotoxin detection techniques, upstream processes for the production of therapeutic molecules, and downstream processes to eliminate endotoxins during product purification. Finally, we have evaluated the effectiveness of endotoxin removal processes from a perspective of high purity and low cost.

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Application of ethylenediamine monolith to purify a hemagglutinin influenza deoxyribonucleic acid-based vaccine

Cited by 11 publications

References 43 publications

Influenza DNA vaccine purification using pHEMA cryogel support

Influenza DNA vaccine purification using pHEMA cryogel support

Untitled

Current technologies to endotoxin detection and removal for biopharmaceutical purification

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