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Article ; Online: Reseña de MORAES, Natalia y ROMERO, Héctor (eds.), Asilo y refugio en tiempos de guerra contra la inmigración, Los libros de la Catarata, Madrid, 2019, 238 pp.

Álvaro GONZÁLEZ NAVAS

Relaciones Internacionales, Iss 43, Pp 231-

2020 Volume 234

Keywords	Political science ; J ; International relations ; JZ2-6530
Language	Spanish
Publishing date	2020-02-01T00:00:00Z
Publisher	Universidad Autónoma de Madrid
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Reseña de MORAES, Natalia y ROMERO, Héctor (eds.), Asilo y refugio en tiempos de guerra contra la inmigración, Los libros de la Catarata, Madrid, 2019, 238 pp.

Álvaro GONZÁLEZ NAVAS

Relaciones Internacionales, Iss 43, Pp 231-

2020 Volume 234

Keywords	Political science ; J ; International relations ; JZ2-6530
Language	Spanish
Publishing date	2020-02-01T00:00:00Z
Publisher	Universidad Autónoma de Madrid
Document type	Article ; Online
Database	BASE - Bielefeld Academic Search Engine (life sciences selection)

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Article ; Online: Practical study on the impact of injection conditions in gradient elution mode for the analysis of therapeutic proteins when using very short columns.

Pérez-Robles, Raquel / Fekete, Szabolcs / Navas, Natalia / Guillarme, Davy

Journal of chromatography. A

2023 Volume 1709, Page(s) 464359

Abstract: The impact of injected sample volume on apparent efficiency has been studied for very short columns in a systematic way. For large molecules such as therapeutic proteins, it was found that relatively large volumes can be injected onto ultra-short RPLC ... ...

Abstract	The impact of injected sample volume on apparent efficiency has been studied for very short columns in a systematic way. For large molecules such as therapeutic proteins, it was found that relatively large volumes can be injected onto ultra-short RPLC and IEX columns (i.e. L < 50 mm) without significantly affecting the quality of the separation. This favourable behavior is due to the on-off elution mechanism of large molecules and to the fact that therapeutic protein samples are formulated in aqueous-based media, which is the weakest solvent in RPLC and IEX. Therefore, their peak is strongly focused at the column inlet even when large volume is injected, and pre-column peak dispersion is compensated. However, ultra-short HILIC columns do not seem to be favorable, as they require for very low injection volume to avoid detrimental peak splitting and breakthrough effects. Such peak distortion is related to the inherent solvent mismatch between sample diluent (aqueous) and mobile phase strength (highly organic in HILIC). When studying mass load, the ranking of the elution modes was the same, and the largest relative mass could be injected onto IEX columns (as large as 10% sample to sorbent mass), without affecting the separation quality.
Language	English
Publishing date	2023-09-10
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	1171488-8
ISSN	1873-3778 ; 0021-9673
ISSN (online)	1873-3778
ISSN	0021-9673
DOI	10.1016/j.chroma.2023.464359
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Article ; Online: Outcomes of ECMO support with polypropylene membrane during pandemic times: a retrospective cohort study.

Valenzuela-Faccini, Natalia / Poveda-Henao, Claudia / Flórez-Navas, Catalina / Pérez-Garzón, Michel / Boada-Becerra, Natalia / Mercado-Diaz, Mario / Salcedo, Patricia / Robayo-Amortegui, Henry

BMC pulmonary medicine

2024 Volume 24, Issue 1, Page(s) 41

Abstract: Background: The SARS-CoV-2 pandemic resulted in shortages of supplies, which limited the use of extracorporeal membrane oxygenation (ECMO) support. As a contingency strategy, polypropylene (PP) oxygenation membranes were used. This study describes the ... ...

Abstract	Background: The SARS-CoV-2 pandemic resulted in shortages of supplies, which limited the use of extracorporeal membrane oxygenation (ECMO) support. As a contingency strategy, polypropylene (PP) oxygenation membranes were used. This study describes the clinical outcomes in patients on ECMO with PP compared to poly-methylpentene (PMP) oxygenation membranes. Methods: Retrospective cohort of patients in ECMO support admitted between 2020 and 2021. Results: A total of 152 patients with ECMO support were included, 71.05% were men with an average age of 42 (SD 9.91) years. Veno-venous configuration was performed in 75.6% of cases. The PP oxygenation membranes required more changes 22 (63.1%), than the PMP Sorin® 24 (32,8%) and Euroset® 15 (31,9%) (p.0.022). The main indication for membrane change was low oxygen transfer for PP at 56.2%, Sorin® at 50%, and Euroset® at 14.8%. Renal replacement therapy was the most frequent complication with PP membrane in 22 patients (68.7%) Sorin® 25 patients (34.2%), and Euroset® 15 patients (31.9%) (p 0.001) without statistically significant differences in mortality. Conclusion: PP oxygenation membranes was a useful and feasible strategy. It allowed a greater disponibility of ECMO support for critically ill in a situation of great adversity during the SARS-CoV-2 pandemic.
MeSH term(s)	Male ; Humans ; Adult ; Female ; Extracorporeal Membrane Oxygenation/adverse effects ; Polypropylenes ; Retrospective Studies ; Pandemics ; SARS-CoV-2 ; Polyenes
Chemical Substances	Polypropylenes ; poly(methylpentene) (9016-80-2) ; Polyenes
Language	English
Publishing date	2024-01-19
Publishing country	England
Document type	Journal Article
ZDB-ID	2059871-3
ISSN	1471-2466 ; 1471-2466
ISSN (online)	1471-2466
ISSN	1471-2466
DOI	10.1186/s12890-023-02753-5
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article ; Online: Improved sample introduction approach in hydrophilic interaction liquid chromatography to avoid breakthrough of proteins.

Pérez-Robles, Raquel / Fekete, Szabolcs / Kormány, Róbert / Navas, Natalia / Guillarme, Davy

Journal of chromatography. A

2023 Volume 1713, Page(s) 464498

Abstract: When therapeutic proteins are analysed under hydrophilic interaction liquid chromatography (HILIC) conditions, there is an inherent mismatch between the sample diluent (proteins must be solubilised in aqueous media) and the mobile phase, which is mostly ... ...

Abstract	When therapeutic proteins are analysed under hydrophilic interaction liquid chromatography (HILIC) conditions, there is an inherent mismatch between the sample diluent (proteins must be solubilised in aqueous media) and the mobile phase, which is mostly composed of aprotic solvent (acetonitrile). This difference in eluent strength between sample diluent and mobile phase is responsible for severe analyte breakthrough and peak distortion. As demonstrated with therapeutic proteins of different sizes (insulin of 6 kDa, anakinra of 17 kDa and rituximab subunits of 25 and 50 kDa), only very small volumes of 0.1-0.2 µL can be injected without breakthrough effects, when performing rapid analysis on short HILIC columns of 20-50 mm, leading to poor sensitivity. In order to avoid the undesired effect of the strong sample diluent, a special injection program should be preferred. This consists in the addition and automatic injection of a defined volume of weak solvent (acetonitrile) along with the sample to increase retention factors during sample loading. Various injection programs were tested, including the addition of a pre-injection or post-injection or both (bracketed injection) of acetonitrile plugs. Several weak to strong injection solvent ratios of 1:1, 1:2, 1:4 and 1:10 were tested. Our work proves that the addition of a pre-plug solvent with a weak vs. strong injection solvent ratio of 1:10 is a valuable strategy to inject relatively large volumes of proteins in HILIC, regardless of column dimensions, thus maximising sensitivity. No peak deformation or breakthrough was observed under these conditions. However, it is important to note that peak broadening (40 % larger peaks) was observed when the injection program increased the injection solvent ratio from 1:1 to 1:10. Finally, this strategy was applied to a wide range of therapeutic mAb products with different physico-chemical properties. In all cases, relatively large volumes can be successfully injected onto small volume HILIC columns using a purely aqueous sample diluent, as long as an appropriate (weak) solvent pre-injection is applied.
MeSH term(s)	Chromatography, Liquid ; Solvents/chemistry ; Water/chemistry ; Hydrophobic and Hydrophilic Interactions ; Acetonitriles/chemistry ; Indicators and Reagents
Chemical Substances	Solvents ; Water (059QF0KO0R) ; acetonitrile (Z072SB282N) ; Acetonitriles ; Indicators and Reagents
Language	English
Publishing date	2023-11-10
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	1171488-8
ISSN	1873-3778 ; 0021-9673
ISSN (online)	1873-3778
ISSN	0021-9673
DOI	10.1016/j.chroma.2023.464498
Database	MEDical Literature Analysis and Retrieval System OnLINE

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Article: Comprehensive Analysis of Nivolumab, A Therapeutic Anti-Pd-1 Monoclonal Antibody: Impact of Handling and Stress.

Torrente-López, Anabel / Hermosilla, Jesús / Salmerón-García, Antonio / Cabeza, José / Navas, Natalia

Pharmaceutics

2022 Volume 14, Issue 4

Abstract: Nivolumab, formulated in the medicine ... ...

Abstract	Nivolumab, formulated in the medicine Opdivo
Language	English
Publishing date	2022-03-23
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2527217-2
ISSN	1999-4923
ISSN	1999-4923
DOI	10.3390/pharmaceutics14040692
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Article ; Online: Practical study on the impact of injection conditions in gradient elution mode for the analysis of therapeutic proteins when using very short columns

Pérez-Robles, Raquel / Fekete, Szabolcs / Navas, Natalia / Guillarme, Davy

Journal of Chromatography A. 2023 Oct., v. 1709 p.464359-

2023

Abstract	The impact of injected sample volume on apparent efficiency has been studied for very short columns in a systematic way. For large molecules such as therapeutic proteins, it was found that relatively large volumes can be injected onto ultra-short RPLC and IEX columns (i.e. L < 50 mm) without significantly affecting the quality of the separation. This favourable behavior is due to the on-off elution mechanism of large molecules and to the fact that therapeutic protein samples are formulated in aqueous-based media, which is the weakest solvent in RPLC and IEX. Therefore, their peak is strongly focused at the column inlet even when large volume is injected, and pre-column peak dispersion is compensated. However, ultra-short HILIC columns do not seem to be favorable, as they require for very low injection volume to avoid detrimental peak splitting and breakthrough effects. Such peak distortion is related to the inherent solvent mismatch between sample diluent (aqueous) and mobile phase strength (highly organic in HILIC). When studying mass load, the ranking of the elution modes was the same, and the largest relative mass could be injected onto IEX columns (as large as 10% sample to sorbent mass), without affecting the separation quality.
Keywords	chromatography ; solvents ; sorbents ; therapeutics ; Loading capacity ; injection volume ; ultra-short columns ; monoclonal antibodies ; proteins ; ion exchange chromatography
Language	English
Dates of publication	2023-10
Publishing place	Elsevier B.V.
Document type	Article ; Online
ZDB-ID	218139-3
ISSN	0021-9673 ; 0378-4355 ; 0376-737X
ISSN	0021-9673 ; 0378-4355 ; 0376-737X
DOI	10.1016/j.chroma.2023.464359
Database	NAL-Catalogue (AGRICOLA)

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Article: Analysing the In-Use Stability of mRNA-LNP COVID-19 Vaccines Comirnaty™ (Pfizer) and Spikevax™ (Moderna): A Comparative Study of the Particulate.

Hermosilla, Jesús / Alonso-García, Airan / Salmerón-García, Antonio / Cabeza-Barrera, José / Medina-Castillo, Antonio L / Pérez-Robles, Raquel / Navas, Natalia

Vaccines

2023 Volume 11, Issue 11

Abstract: Comirnaty™ and Spikevax™ were the first vaccines approved for human use based on modified non-replicating mRNA lipophilic nanoparticle (mRNA-LNP) technology, with great success in the treatment of COVID-19. They have been used massively worldwide. One of ...

Abstract	Comirnaty™ and Spikevax™ were the first vaccines approved for human use based on modified non-replicating mRNA lipophilic nanoparticle (mRNA-LNP) technology, with great success in the treatment of COVID-19. They have been used massively worldwide. One of the major inconveniences of these vaccines is related to pharmaceutical stability issues. Proper transportation, storage, and in-use handling before administration to patients are critical steps since failures can potentially reduce potency. In this research, the in-use stability of Comirnaty™ and Spikevax™ clinical samples was analysed and the results were compared. As changes in the size of the mRNA-LNPs are related to potency, these modifications were analysed by qualitative Dynamic Light Scattering (DLS) as a stability-indicating method for control and stressed vaccine samples. Strong stress factors (accelerated light irradiation, manual shaking, and vortex vibration) and conditions that mimic in-use handling (exposure to natural light and room temperature, repeated cycles of injections, and 24 h storage in syringes) were checked. The morphology of the mRNA-LNPs was analysed by Transmission Electron Microscopy (TEM) to better interpret and support the DLS results. Although the two vaccines are based on the same mRNA-LNP technology, the results demonstrate that they are characterised by very different particle size profiles and behaviours against different handling/stress conditions.
Language	English
Publishing date	2023-10-25
Publishing country	Switzerland
Document type	Journal Article
ZDB-ID	2703319-3
ISSN	2076-393X
ISSN	2076-393X
DOI	10.3390/vaccines11111635
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Article ; Online: Comprehensive physicochemical and functional analysis of pembrolizumab based on controlled degradation studies: Impact on antigen-antibody binding.

Torrente-López, Anabel / Hermosilla, Jesús / Salmerón-García, Antonio / Cabeza, José / Ruiz-Martínez, Adolfina / Navas, Natalia

European journal of pharmaceutics and biopharmaceutics : official journal of Arbeitsgemeinschaft fur Pharmazeutische Verfahrenstechnik e.V

2023 Volume 194, Page(s) 131–147

Abstract: Monoclonal antibodies-based medicines are widely used in the treatment of different diseases. These medicines are very sensitive to exposure to different environmental conditions and their handling in hospitals may affect their safety and efficacy. This ... ...

Abstract	Monoclonal antibodies-based medicines are widely used in the treatment of different diseases. These medicines are very sensitive to exposure to different environmental conditions and their handling in hospitals may affect their safety and efficacy. This is the case for pembrolizumab (Keytruda®, 25 mg/mL), for which there is not yet much information on its risk behaviour associated with routine handling or unintentional mishandling. Here we performed a wider physicochemical and functional analysis of pembrolizumab medicine including controlled degradation studies: heat, freeze/thaw, agitation, accelerated light exposure and high hypertonic solution. After that, the samples were analysed by a set of analytical techniques to evaluated critical quality attributes: Far-UV CD, IT-FS, DLS, RP/UHPLC(UV)-MS, SE/UHPLC(UV), RP/UHPLC(UV)-MS/MS and ELISA. The results provide an in-depth understanding of the biochemical and biophysical properties of pembrolizumab, showing that the medicine is affected by accelerated light exposure and temperature of 60 °C, demonstrated by the detection of non-natural dimers and HMWS. Light exposure also revealed different isoform profile and increase in oxidations. Regarding functionality by means of the interaction antigen-antibody binding, all the stressors promoted a decrease in pembrolizumab capacity to bind to PD-1 receptor, although the biological activity remained still high for all of them, being 60 °C and accelerated light exposure the most affected.
MeSH term(s)	Tandem Mass Spectrometry ; Antibodies, Monoclonal, Humanized ; Antibodies, Monoclonal/chemistry ; Temperature
Chemical Substances	pembrolizumab (DPT0O3T46P) ; Antibodies, Monoclonal, Humanized ; Antibodies, Monoclonal
Language	English
Publishing date	2023-12-13
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	1065368-5
ISSN	1873-3441 ; 0939-6411
ISSN (online)	1873-3441
ISSN	0939-6411
DOI	10.1016/j.ejpb.2023.12.005
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Article ; Online: First releases of hatchery-produced Senegal sole (Solea senegalensis), brill (Scophthalmus rhombus), and wedge sole (Dicologoglossa cuneata) juveniles in the South-western Spanish coast

Herrera, Marcelino / Rodiles, Ana / Salamanca, Natalia / Navas, Jose Ignacio / Cordero, María Luisa / Hachero, Ismael

Hydrobiologia. 2023 Jan., v. 850, no. 1 p.203-214

2023

Abstract: The regression of fisheries in the Gulf of Cadiz is evident since current fish catches are 33% of that 30 years before. Consequently, some initiatives for the replenishment of exhausted wild stocks are welcome. The objective of the present work is to ... ...

Abstract	The regression of fisheries in the Gulf of Cadiz is evident since current fish catches are 33% of that 30 years before. Consequently, some initiatives for the replenishment of exhausted wild stocks are welcome. The objective of the present work is to describe and analyse the results coming from the first flatfish stock enhancements in Andalusia. A total of 3189 fish from three flatfish species: Senegal sole (Solea senegalensis Kaup), wedge sole (Dicologlossa cuneata Moreau), and brill (Scophthalmus rhombus Linnaeus) were tagged and released. Several variables were calculated through the data analysis of recovered fish. Some variables were calculated only for Senegal soles since wedge sole and brill recaptures were not significant. The Senegal sole recapture rate was 2.71 ± 0.72, similar to other published data, the recapture rates for bigger fish being higher though not significant. No significant differences were detected for distance, time, growth, or recapture rate amongst initial Senegal sole sizes. Around 80% of recaptures were registered within 15 weeks after release. The results show that it is possible for the release and recovery of tagged Senegal soles in the Gulf of Cadiz. Future long-term programmes on stock enhancement could help to determine the effects on fisheries and recover stocks.
Keywords	Dicologlossa cuneata ; Scophthalmus rhombus ; Solea senegalensis ; coasts ; fish ; Senegal
Language	English
Dates of publication	2023-01
Size	p. 203-214.
Publishing place	Springer International Publishing
Document type	Article ; Online
ZDB-ID	214428-1
ISSN	1573-5117 ; 0018-8158
ISSN (online)	1573-5117
ISSN	0018-8158
DOI	10.1007/s10750-022-05054-w
Database	NAL-Catalogue (AGRICOLA)

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