Analytical Assessment of Leachables in Biological Drug Products: ... - Seguridad Mania.com - España y América Latina
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Lunes 2 de Set, 2024
Full title: Analytical Assessment of Leachables in Biological Drug Products: FDA Approach and Experience in Reviewing Information Biological drug products (biologicals; such as therapeutic proteins, vaccine-, gene-, and cell therapy-based) are produced via multi-step processes involving multiple materials contacting intermediates and sourcing numerous leachables into final drug products (DP). Such steps involve (i) purification of intermediates using chromatography, centrifuging, dialysis, filtering, and filling in final container closure system, etc., (ii) shelf-life storage and (iii) in-use hold of DP. The respective contact materials involve chromatography resins, filtering/dialysis membranes, tubing, collecting bags/tanks, gaskets, valves, final container closure systems, etc. By these, the assessment of leachables risk in biologics is the most challenging compared to other types of DPs. However, current guidances are generally focused on assessment of the leachables only from single manufacturing components, scored to be high-risk for leachables, and by this, underestimate other components scored to have the lower risk. Following these directions, manufacturers typically perform the assessments only for the high-risk components and by this, underestimate the contribution of other materials to the overall (cumulative) leachables profile in final DP. Other typical issues involve (i) non-validation of analytical methods, resulting in ambiguity in Analytical Uncertainty Factor (AUF) used for calculation of the Analytical Evaluation Threshold (AET; reporting limit in an assay), (ii) missing the assessment of elemental (ionic) leachables, or (iii) incorrect leachables study design; altogether also resulting in potential underestimation of the leachables risk. These issues usually cause multiple back-and-forth communications between the FDA and Sponsor during the applications’ (BLAs and supplements) review, typically ending up with post-marketing requirements.
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La Autoridad Portuaria de la Bahía de Algeciras (APBA) ha instalado cámaras térmicas en las zonas de mayor tránsito de pasajeros del puerto para controlar la temperatura corporal de los pasajeros sin necesidad de pararles. ... Leer más ►
Tags: Casos, Transporte, Video analítica
Publicado el 2-Jul-2020 • 14.23hs
Publicado el 25-Ene-2017 • 19.27hs
Publicado el 20-Ene-2017 • 13.11hs
Publicamos grabación de webinar que tuvo lugar el pasado 28/03/2019 por el CIO del Grupo de Medios de Comunicación español Vocento Jorge Oteo en el que explica su visión de la Ciberseguridad hoy. ... Leer más ►
Tags: Teoría, Medios de Comunicación, Ciberseguridad, Webinars grabados
Publicado el 29-Mar-2019 • 10.12hs
Publicado el 20-Jun-2018 • 11.21hs
Publicado el 31-May-2018 • 10.21hs
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Tags: Producto, Todos, Ciberterrorismo
Publicado el 23-Jun-2020 • 16.05hs
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Publicado el 31-May-2011 • 05.13hs
Publicado el 25-Set-2008 • 17.54hs
Publicado el 1-Set-2016 • 16.11hs
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Publicado el 26-Set-2019 • 10.36hs
Publicado el 29-Mar-2019 • 10.12hs
Publicado el 23-Jun-2020 • 16.05hs
Publicado el 15-Mar-2019 • 10.41hs
Publicado el 4-Feb-2016 • 11.56hs
Publicado el 21-Jun-2012 • 22.28hs
Publicado el 13-Jul-2012 • 07.12hs
Publicado el 17-Ene-2012 • 10.22hs
Publicado el 25-Ene-2017 • 19.27hs
Publicado el 18-Set-2013 • 17.44hs
Publicado el 17-May-2018 • 10.47hs
Publicado el 28-Dic-2015 • 12.39hs
Publicado el 5-Feb-2016 • 13.01hs
Publicado el 2-Jul-2020 • 14.23hs
Publicado el 25-May-2016 • 13.01hs