Full Title: USP Standards to Support Qualification of Raw Materials and Cell Substrates for Biomanufacturing The quality of starting materials is critical for successful pharmaceutical manufacturing strategies. For biomanufacturing the challenges are further amplified due to the use of a wide variety of raw materials, cell lines, and naturally-derived materials with an increased risk for the introduction of unwanted impurities and adventitious agents. This presentation will provide an overview and updates on USP documentary standards containing best practices for qualifying incoming materials, demonstrating viral clearance, cryopreservation, cell banking, and controlling impurities derived from cell substrates for therapeutic proteins. Presented by Maura C. Kibbey, Ph.D., Director, Science & Standards, Global Biologics, U.S. Pharmacopeia Dr. Maura Kibbey is a Senior Scientific Fellow for Education and Training in USP’s Global Biologics Department. As USP’s refocused its strategy for biologics standards, Dr. Kibbey has collaborated with scientific experts and trainers to bring many more educational offerings to USP’s stakeholders. Not only to demonstrate the utility of these new standards but to also receive more feedback on future standards for advanced therapies. This role builds on her previous responsibilities directing USP scientists developing compendial standards.  Before joining USP, Dr. Kibbey worked for several biotechnology and diagnostic companies in the Washington DC area in scientific, management, marketing, and business development roles, as well as performing cancer research at the National Institutes of Health. Her scientific expertise includes development and validation of many different assay types for measurement of individual molecules, their activities, or binding interactions. She has published over 40 peer-reviewed articles and has been an invited speaker or workshop organizer for numerous scientific conferences.

Hora

16:00 - 17:00 hs GMT+1

Organizador

BioPharma Asia Magazine
Compartir
Enviar a un amigo
Mi email *
Email destinatario *
Comentario *
Repite estos números *
Control de seguridad
Agosto / 2025 309 webinars
Lunes
Martes
Miércoles
Jueves
Viernes
Sábado
Domingo
Lun 28 de Agosto de 2025
Mar 29 de Agosto de 2025
Mié 30 de Agosto de 2025
Jue 31 de Agosto de 2025
Vie 01 de Agosto de 2025
Sáb 02 de Agosto de 2025
Dom 03 de Agosto de 2025
Lun 04 de Agosto de 2025
Mar 05 de Agosto de 2025
Mié 06 de Agosto de 2025
Jue 07 de Agosto de 2025
Vie 08 de Agosto de 2025
Sáb 09 de Agosto de 2025
Dom 10 de Agosto de 2025
Lun 11 de Agosto de 2025
Mar 12 de Agosto de 2025
Mié 13 de Agosto de 2025
Jue 14 de Agosto de 2025
Vie 15 de Agosto de 2025
Sáb 16 de Agosto de 2025
Dom 17 de Agosto de 2025
Lun 18 de Agosto de 2025
Mar 19 de Agosto de 2025
Mié 20 de Agosto de 2025
Jue 21 de Agosto de 2025
Vie 22 de Agosto de 2025
Sáb 23 de Agosto de 2025
Dom 24 de Agosto de 2025
Lun 25 de Agosto de 2025
Mar 26 de Agosto de 2025
Mié 27 de Agosto de 2025
Jue 28 de Agosto de 2025
Vie 29 de Agosto de 2025
Sáb 30 de Agosto de 2025
Dom 31 de Agosto de 2025

.

  • Comparativas de Software

    ¿No te salen las cuentas en la nube?

    La nube tiene importantes ventajas: ahorros de costes, facilidad para trabajar en equipos remotos, menor necesidad de administración de la infraestructura, mejoras de seguridad, etc. Sin embargo, al comentar con algunos clientes la posibilidad de migrar las licencias de Atlassian a cloud, me comentaron que habían hecho alguna experiencia de migración y no le salían tan bien las cuentas. Estos comentarios me hicieron reflexionar sobre cuáles podían ser las causas de que no salieran las cuentas y permitirme ofrecer algunas recomendaciones y consejos. ... Leer más

    Publicado el 22-Dic-2021 • 14.40hs

    0 comentarios

  • TODOS Comparativas de Software PDF

    Comparativas de software ERP para todos los sectores

    Publicado el 27-Set-2021 • 12.50hs

  • TODOS Comparativas de Software PDF

    Comparativas de software ERP para Fabricación

    Publicado el 27-Set-2021 • 09.51hs

.

.

.

.

.

Más Secciones »

Hola Invitado