Large scale Production of Biologics is susceptible to microbial contamination because many manufacturing steps occur under non-sterile conditions in aqueous systems at ambient temperature or 2-8 °C under substantially neutral pH conditions. Regardless of where in the Drug Substance (DS) manufacture (manufacture of the Active Pharmaceutical Ingredient), or Drug Product (DP) manufacture (manufacture of the Final Drug, e.g. formulated mAbs filled in vials or syringes) they occur, microbial contaminations can have a significant impact on product quality and patient safety. Even after bioburden removal by 0.2 µm filtration subcellular microbial components like toxins, lipopeptide/lipoproteins, flagellin, bacterial and fungal DNA, cell wall polysaccharides, extracellular proteases or endoglycosidases remain in the product. Those microbial components potentially lead to toxic, allergic or inflammatory responses in humans or product degradation or modification. The CCAB approach described here enables a comprehensive assessment of these risks.

Hora

10:00 - 11:00 hs GMT+1

Organizador

BioPharma Asia Magazine
Compartir
Enviar a un amigo
Mi email *
Email destinatario *
Comentario *
Repite estos números *
Control de seguridad
Agosto / 2019 494 webinars
Lunes
Martes
Miércoles
Jueves
Viernes
Sábado
Domingo
Lun 29 de Agosto de 2019
Mar 30 de Agosto de 2019
Mié 31 de Agosto de 2019
Jue 01 de Agosto de 2019
Vie 02 de Agosto de 2019
  • Ask an Expert: Windows

    19:00 - 20:00 hs GMT+1

    Fecha
    Vie 2-Ago-2019, 19:00 - 20:00 hs GMT+1
    Descripción
    As Ansible has grown in popularity, so have its ability to automate Windows systems. Whether you’re deploying Windows in the cloud, or managing on-prem instances, Ansible offers a number of capabilities that can help with the deployment and management of (...)
    Cerrar
  • Ask an Expert: Windows

    19:00 - 20:00 hs GMT+1

    Fecha
    Vie 2-Ago-2019, 19:00 - 20:00 hs GMT+1
    Descripción
    As Ansible has grown in popularity, so have its ability to automate Windows systems. Whether you’re deploying Windows in the cloud, or managing on-prem instances, Ansible offers a number of capabilities that can help with the deployment and management of (...)
    Cerrar
Sáb 03 de Agosto de 2019
Dom 04 de Agosto de 2019
Lun 05 de Agosto de 2019
Mar 06 de Agosto de 2019
Mié 07 de Agosto de 2019
Jue 08 de Agosto de 2019
Vie 09 de Agosto de 2019
Sáb 10 de Agosto de 2019
Dom 11 de Agosto de 2019
Lun 12 de Agosto de 2019
Mar 13 de Agosto de 2019
Mié 14 de Agosto de 2019
Jue 15 de Agosto de 2019
Vie 16 de Agosto de 2019
Sáb 17 de Agosto de 2019
Dom 18 de Agosto de 2019
Lun 19 de Agosto de 2019
Mar 20 de Agosto de 2019
Mié 21 de Agosto de 2019
Jue 22 de Agosto de 2019
Vie 23 de Agosto de 2019
Sáb 24 de Agosto de 2019
Dom 25 de Agosto de 2019
Lun 26 de Agosto de 2019
Mar 27 de Agosto de 2019
Mié 28 de Agosto de 2019
Jue 29 de Agosto de 2019
Vie 30 de Agosto de 2019
Sáb 31 de Agosto de 2019
Dom 01 de Agosto de 2019

Publicidad

Ofertas de empleo para profesionales IT en España y América Latina - TIC-Jobs.com

Ofertas de empleo IT, TIC, ERP, Consultor, Administrador, Programador, Desarrollador, Business Intelligence, BI, Business Process Management, BPM, CRM, Dynamics, ECM, RRHH, SAP, Sharepoint, WCM, Sharepoint, Navision, España, México, Argentina, Chile, Brasil,Perú

Lo más leído »

Publicidad

Más Secciones »

Hola Invitado