Publications

Extracellular Vesicles as Next-Generation Diagnostics and Advanced Therapy Medicinal Products

Stawarska, Agnieszka; Bamburowicz-Klimkows, Magdalena; Rundén-Pran, Elise; Dusinska, Maria; Cimpan, Mihaela Roxana; Rios Mondragon, Ivan; Grudzinski, Ireneusz P.

Extracellular vesicles (EVs) hold great promise for clinical application as new diagnostic and therapeutic modalities. This paper describes major GMP-based upstream and downstream manufacturing processes for EV large-scale production, also focusing on post-processing technologies such as surface bioengineering and uploading studies to yield novel EV-based diagnostics and advanced therapy medicinal products. This paper also focuses on the quality, safety, and efficacy issues of the bioengineered EV drug candidates before first-in-human studies. Because clinical trials involving extracellular vesicles are on the global rise, this paper encompasses different clinical studies registered on clinical-trial register platforms, with varying levels of advancement, highlighting the growing interest in EV-related clinical programs. Navigating the regulatory affairs of EVs poses real challenges, and obtaining marketing authorization for EV-based medicines remains complex due to the lack of specific regulatory guidelines for such novel products. This paper discusses the state-of-the-art regulatory knowledge to date on EV-based diagnostics and medicinal products, highlighting further research and global regulatory needs for the safe and reliable implementation of bioengineered EVs as diagnostic and therapeutic tools in clinical settings. Post-marketing pharmacovigilance for EV-based medicinal products is also presented, mainly addressing such topics as risk assessment and risk management.

MDPI

Extensive reduction of surface UV radiation since 1750 in world's populated regions.

Kvalevåg, M.M.; Myhre, G.; Myhre, C.L.

Extending the long-term record of volcanic SO2 emissions with the Ozone Mapping and Profiler Suite nadir mapper.

Carn, S. A.; Yang, K.; Prata, A. J.; Krotkov, N. A.

ExSIRA - Experimental study to investigate risk of selected amines (project no. 199874/S60). NILU PP

Berglen, T.F.; ExSIRA project team.

ExSIRA - Experimental Study to Investigate Risk of selected Amines "Fly me to the moon". NILU F

Velken, A.v.S.

Exposure to PFAS is associated with telomere length dynamics and demographic responses of an arctic top predator

Sebastiano, Manrico; Angelier, Frédéric; Blévin, Pierre; Ribout, Cécile; Sagerup, Kjetil; Descamps, Sebastien; Herzke, Dorte; Moe, Børge; Barbarud, Christophe; Bustnes, Jan Ove; Gabrielsen, Geir W.; Chastel, Olivier

Exposure to oxychlordane is associated with shorter telomeres in arctic breeding kittiwakes.

Blevin, P.; Angelier, F.; Tartu, S.; Ruault, S.; Bustamante, P.; Herzke, D.; Moe, B.; Bech, C.; Gabrielsen, G.W.; Bustnes, J.O.; Chastel, O.

Exposure scenario approach to environmental health problems: two case studies. NILU F

Bartonova, A.; Liu, H.Y.; Loh, M.; ENVIRISK team.

Exposure of children to particulate matter in urban areas - model calculations.

Fløisand, I.; Mc Innes, H.; Broday, D.; Lützenkirchen, S.; Holländer, W.; Bartonova, A.

Exposure modelling related to outdoor air.

Bartonova, A.; Laupsa, H.

Exposure assessment with the urban exposure management tool - case study Oslo.

Lützenkirchen, S.; Laupsa, H.; Fløisand, I.; Bøhler, T.; Hollander, W.; Broday, D.M.

Exploring the role of sea-ice for seasonal forecasts.

Senan, R.; Benestad, R.E.; Balmaseda, M.; Ferranti, L.; Orsolini, Y.J.; Melsom, A.