Analytical Strategies for Comparability in Bioprocess Development

◄ Volver al calendario

Presented by Dr Christine P. Chan, Ph.D. of Sanofi Comparability exercises are commonly required at certain milestones during drug development as well as after product registration when changes are implemented into the manufacturing process. The goal is to evaluate if the product remains highly similar (not necessarily identical) before and after the change in terms of quality and stability and have no adverse impact on safety and efficacy predicted for the patients. This assessment requires product-specific knowledge gathered through drug development, taking a totality-of-evidence approach. The different levels of information are obtained from analytical studies for characterization of the molecule, animal studies for toxicity, pharmacokinetics and pharmacodynamics for pharmacological activities, and clinical studies for safety/tolerability, immunogenicity and efficacy. This Webinar discusses strategies and considerations for analytical characterization of protein structure and function which forms the foundation of the comparability demonstration.

Hora

16:00 - 17:00 hs GMT+1

Suscripción

Ver más información y suscribirse al webinar »

Organizador

BioPharma Asia Magazine

Compartir ▼

Disminuir tamaño de letra Aumentar tamaño de letra

Webinars »

Suscribirme!

Septiembre / 2020 37 webinars

« Anterior | Siguiente »

Lunes

Martes

Miércoles

Jueves

Viernes

Sábado

Domingo

Lun 31 de Septiembre de 2020

Mar 01 de Septiembre de 2020

Mié 02 de Septiembre de 2020

Dell & NVIDIA AI Partner Champions Program 8

12:00 - 13:00 hs GMT+1

Dell & NVIDIA AI Partner Champions Program 8

Fecha

Mié 2-Set-2020, 12:00 - 13:00 hs GMT+1

Descripción

Dell & NVIDIA AI Partner Champions Program 8

Más detalles »
Cerrar
Dell & NVIDIA AI Partner Champions Program 8

12:00 - 13:00 hs GMT+1

Dell & NVIDIA AI Partner Champions Program 8

Fecha

Mié 2-Set-2020, 12:00 - 13:00 hs GMT+1

Descripción

Dell & NVIDIA AI Partner Champions Program 8

Más detalles »
Cerrar
The Impact on Using Rapid Methods For Environmental Monitoring

16:00 - 17:00 hs GMT+1

The Impact on Using Rapid Methods For Environmental Monitoring

Fecha

Mié 2-Set-2020, 16:00 - 17:00 hs GMT+1

Descripción

Presented by Dr. Michael J. Miller, President of Microbiology Consultants, LLC

Más detalles »
Cerrar

y 1 webinar más

Jue 03 de Septiembre de 2020

Case Study: Fully Utilizing Closed Systems in Modern BioPharma Facilities

16:00 - 17:00 hs GMT+1

Case Study: Fully Utilizing Closed Systems in Modern BioPharma Facilities

Fecha

Jue 3-Set-2020, 16:00 - 17:00 hs GMT+1

Descripción

Presented by Lars Hovmand-Lyster, Senior Engineering Specialist in Novo Nordisk Global Project Office (GPO) Engineering Management Department • Build the roadmap to biopharmaceutical manufacturing and their partners in developing, assessing and verifying unit operations leading to an appropriate facility design that is “right (...)

Más detalles »
Cerrar
Industria 4.0 en la protección de equipos mineros

17:00 - 18:00 hs GMT+1

Industria 4.0 en la protección de equipos mineros

Fecha

Jue 3-Set-2020, 17:00 - 18:00 hs GMT+1

Descripción

La Industria 4.0 abre nuevos horizontes en prácticamente todas las áreas del conocimiento, tanto científico como aplicado. En el caso de las ciencias de materiales, las diferentes protecciones que se desarrollan para las maquinarias mineras buscan disminuir sus costos operacionales (...)

Más detalles »
Cerrar

Vie 04 de Septiembre de 2020

Quantification and Control of Amorphous contents by Raman, Application and Case

16:00 - 17:00 hs GMT+1

Quantification and Control of Amorphous contents by Raman, Application and Case

Fecha

Vie 4-Set-2020, 16:00 - 17:00 hs GMT+1

Descripción

Full Title: Quantification and Control of Amorphous contents by Raman, Application and Case Studies in Pharmaceutical Processing Presented by Michelle Raikes, M.S., Scientist IV and Dr. Fredrik Nordstrom, Sr Research Fellow at Boehringer Ingelheim Amorphous regions in crystalline material can have significant (...)

Más detalles »
Cerrar

Sáb 05 de Septiembre de 2020

Dom 06 de Septiembre de 2020

Lun 07 de Septiembre de 2020

Mar 08 de Septiembre de 2020

Case Study: Global Sterile Transportation and Formulation of an Adjuvant

10:00 - 11:00 hs GMT+1

Case Study: Global Sterile Transportation and Formulation of an Adjuvant

Fecha

Mar 8-Set-2020, 10:00 - 11:00 hs GMT+1

Descripción

Presented by Charlotte Masy, Project Manager in global support GSK vaccinés • Understand how to develop a solution for global use • Uncover the challenge of sterile product transportation (E&L) • Discuss the pros and cons of single use solutions in this type (...)

Más detalles »
Cerrar
Case Study: Global Sterile Transportation and Formulation of an Adjuvant

10:00 - 11:00 hs GMT+1

Case Study: Global Sterile Transportation and Formulation of an Adjuvant

Fecha

Mar 8-Set-2020, 10:00 - 11:00 hs GMT+1

Descripción

Presented by Charlotte Masy, Project Manager in global support GSK vaccinés • Understand how to develop a solution for global use • Uncover the challenge of sterile product transportation (E&L) • Discuss the pros and cons of single use solutions in this type (...)

Más detalles »
Cerrar
Operationalizing Cyber Threat Intel for Computer Network Defense: Focus on Iran

11:00 - 12:00 hs GMT+1

Operationalizing Cyber Threat Intel for Computer Network Defense: Focus on Iran

Fecha

Mar 8-Set-2020, 11:00 - 12:00 hs GMT+1

Descripción

Operationalizing Cyber Threat Intelligence (CTI) helps mitigate risk by focusing people, processes, and technology on the threat activity matters. Above all, it allows organizations to take a more proactive, structured, and holistic approach to security that reduces dwell time and (...)

Más detalles »
Cerrar

y 1 webinar más

Mié 09 de Septiembre de 2020

Extractables and Leachables Testing Using a Quality Risk Management Approach

16:00 - 17:00 hs GMT+1

Extractables and Leachables Testing Using a Quality Risk Management Approach

Fecha

Mié 9-Set-2020, 16:00 - 17:00 hs GMT+1

Descripción

Presented by Dhaval Tapiawala, Principal Scientist at Pfizer • Understanding extractables and leachables for better adoption of single use systems • Ensuring safety of drug through determining the level of leachables throughout product life cycle • Case Study of implementation of standardized testing (...)

Más detalles »
Cerrar

Jue 10 de Septiembre de 2020

Vie 11 de Septiembre de 2020

From Concept to Market – Unique Approaches in Biomanufacturing

09:00 - 10:00 hs GMT+1

From Concept to Market – Unique Approaches in Biomanufacturing

Fecha

Vie 11-Set-2020, 09:00 - 10:00 hs GMT+1

Descripción

Presented by Dr. Jincai Li, Vice President of WuXi Biologics With the rapid growth of the biotherapeutics industry, the need and challenge for high quality cost efficient production have been increasing as well. At the same time, the number of approved (...)

Más detalles »
Cerrar
From Concept to Market – Unique Approaches in Biomanufacturing

09:00 - 10:00 hs GMT+1

From Concept to Market – Unique Approaches in Biomanufacturing

Fecha

Vie 11-Set-2020, 09:00 - 10:00 hs GMT+1

Descripción

Presented by Dr. Jincai Li, Vice President of WuXi Biologics With the rapid growth of the biotherapeutics industry, the need and challenge for high quality cost efficient production have been increasing as well. At the same time, the number of approved (...)

Más detalles »
Cerrar

Sáb 12 de Septiembre de 2020

Dom 13 de Septiembre de 2020

Lun 14 de Septiembre de 2020

Mar 15 de Septiembre de 2020

Best PDM for SolidWorks Design Productivity

14:00 - 15:00 hs GMT+1

Best PDM for SolidWorks Design Productivity

Fecha

Mar 15-Set-2020, 14:00 - 15:00 hs GMT+1

Descripción

See why Teamcenter inside SolidWorks is the best PDM for your team! Whether you have 5 or 50 SolidWorks designers, attend this webinar to see why Teamcenter is the best product data management (PDM) software to improve design productivity by 25 (...)

Más detalles »
Cerrar
Analytical Strategies for Comparability in Bioprocess Development

16:00 - 17:00 hs GMT+1

Analytical Strategies for Comparability in Bioprocess Development

Fecha

Mar 15-Set-2020, 16:00 - 17:00 hs GMT+1

Descripción

Presented by Dr Christine P. Chan, Ph.D. of Sanofi Comparability exercises are commonly required at certain milestones during drug development as well as after product registration when changes are implemented into the manufacturing process. The goal is to evaluate if the (...)

Más detalles »
Cerrar
Cómo comparar ERP Local vs ERP en la nube

16:00 - 17:30 hs GMT+1

Cómo comparar ERP Local vs ERP en la nube

Fecha

Mar 15-Set-2020, 16:00 - 17:30 hs GMT+1

Descripción

Las ofertas de la nube son uno de los factores principales que han impulsado a las compañías a remplazar sus modelos de licencia de software ERP local. ¿Pero es en realidad una oferta ERP en la nube más ventajosa que (...)

Más detalles »
Cerrar

y 1 webinar más

Mié 16 de Septiembre de 2020

Verizon Threat Research Advisory Center Monthly Intelligence Briefing (MIB)

16:00 - 17:00 hs GMT+1

Verizon Threat Research Advisory Center Monthly Intelligence Briefing (MIB)

Fecha

Mié 16-Set-2020, 16:00 - 17:00 hs GMT+1

Descripción

Join us—the Verizon Threat Research Advisory Center – for our Monthly Intelligence Briefing (MIB) to discuss the current cybersecurity threat landscape. This webinar will cover: •Current Intelligence Overview •Attacks and Threat Indicators •Latest Malware Trends •Significant Vulnerabilities If you have any questions that you'd like (...)

Más detalles »
Cerrar
Case-by-Case Assessment of Bioburden (CCAB): A Comprehensive Approach to Ass...

19:30 - 20:00 hs GMT+1

Case-by-Case Assessment of Bioburden (CCAB): A Comprehensive Approach to Ass...

Fecha

Mié 16-Set-2020, 19:30 - 20:00 hs GMT+1

Descripción

FULL TITLE: Case-by-Case Assessment of Bioburden (CCAB): A Comprehensive Approach to Assess the Impact of Microbial Impurities on Patient Safety and Product Quality of Biologics Presented by Dr Friedrich von Wintzingerode, QC Lead iNeST Project (individualized Neoantigen Specific Therapy) at (...)

Más detalles »
Cerrar

Jue 17 de Septiembre de 2020

Tap the potential of your business with an ECM strategy

11:00 - 11:30 hs GMT+1

Tap the potential of your business with an ECM strategy

Fecha

Jue 17-Set-2020, 11:00 - 11:30 hs GMT+1

Descripción

Shorter throughput, greater customer orientation: To achieve this, you must constantly review and optimize your processes. In this webinar you will learn how ECM provides you with important business insights. We will show you how you can use Doxis4 to analyze KPIs (...)

Más detalles »
Cerrar
Ciberseguridad con Splunk

11:00 - 12:00 hs GMT+1

Ciberseguridad con Splunk

Fecha

Jue 17-Set-2020, 11:00 - 12:00 hs GMT+1

Descripción

Ciberseguridad con Splunk

Más detalles »
Cerrar

Vie 18 de Septiembre de 2020

Sáb 19 de Septiembre de 2020

Dom 20 de Septiembre de 2020

Lun 21 de Septiembre de 2020

Business Analysis Conference Europe [Live Streaming desde Londres]

07:30 - 16:30 hs GMT+1

Business Analysis Conference Europe [Live Streaming desde Londres]

Fecha

Lun 21-Set-2020, 07:30 - 16:30 hs GMT+1

Descripción

The Business Analysis Conference Europe 2020 will provide an unparalleled networking opportunity for business analysts from across Europe and beyond. Whether you are just starting your BA journey, you are an experienced BA or you would like to understand the (...)

Más detalles »
Cerrar

Mar 22 de Septiembre de 2020

Business Analysis Conference Europe [Live Streaming desde Londres] 2

07:30 - 17:30 hs GMT+1

Business Analysis Conference Europe [Live Streaming desde Londres] 2

Fecha

Mar 22-Set-2020, 07:30 - 17:30 hs GMT+1

Descripción

The Business Analysis Conference Europe 2020 will provide an unparalleled networking opportunity for business analysts from across Europe and beyond. Whether you are just starting your BA journey, you are an experienced BA or you would like to understand the (...)

Más detalles »
Cerrar
Threat Intelligence Drives Effective Vulnerability Management

11:00 - 12:00 hs GMT+1

Threat Intelligence Drives Effective Vulnerability Management

Fecha

Mar 22-Set-2020, 11:00 - 12:00 hs GMT+1

Descripción

Organisations value cyber threat intelligence (CTI) because it helps their security teams stay focused on, and stay ahead of, the most impactful threats. One of the critical strategic and tactical roles that CTI plays is in the tracking, analysis, and (...)

Más detalles »
Cerrar
Analítica avanzada en la industria para mejorar la competitividad

11:00 - 12:00 hs GMT+1

Analítica avanzada en la industria para mejorar la competitividad

Fecha

Mar 22-Set-2020, 11:00 - 12:00 hs GMT+1

Descripción

¿Puede la analítica avanzada mejorar la competitividad de cualquier industria? En este webinar trataremos los siguientes apartados: o Necesidad de mejorar la competitividad en entornos de alta incertidumbre para cualquier industria. o Implantación (...)

Más detalles »
Cerrar
Proofpoint Live Demo: Prevent Phishing Attacks with Security Awareness Training

18:00 - 19:00 hs GMT+1

Proofpoint Live Demo: Prevent Phishing Attacks with Security Awareness Training

Fecha

Mar 22-Set-2020, 18:00 - 19:00 hs GMT+1

Descripción

99% of the phishing attacks Proofpoint observed in 2019 require human interaction to succeed, resulting in malware installation, wire fraud, unwitting data disclosures, and more. Educate your staff and limit cyber attacks through Proofpoint’s industry-leading security awareness training. Backed by (...)

Más detalles »
Cerrar
Best Practices for Nuix Discover Ingestions

19:00 - 20:00 hs GMT+1

Best Practices for Nuix Discover Ingestions

Fecha

Mar 22-Set-2020, 19:00 - 20:00 hs GMT+1

Descripción

Nuix Discover Power User Webinar Series Nuix Discover Ingestions guru Jamie Inghram shares his tried and true practices for efficiently and effectively getting data into Nuix Discover. Watch this session to achieve faster upload times and optimize data organization.

Más detalles »
Cerrar

y 3 webinars más

Mié 23 de Septiembre de 2020

Business Analysis Conference Europe [Live Streaming desde Londres] 3

08:00 - 16:00 hs GMT+1

Business Analysis Conference Europe [Live Streaming desde Londres] 3

Fecha

Mié 23-Set-2020, 08:00 - 16:00 hs GMT+1

Descripción

The Business Analysis Conference Europe 2020 will provide an unparalleled networking opportunity for business analysts from across Europe and beyond. Whether you are just starting your BA journey, you are an experienced BA or you would like to understand the (...)

Más detalles »
Cerrar
Implement the Next Wave of Industry 4.0

19:00 - 20:00 hs GMT+1

Implement the Next Wave of Industry 4.0

Fecha

Mié 23-Set-2020, 19:00 - 20:00 hs GMT+1

Descripción

A company's supply chain is its competitive advantage in the marketplace. Adopting an Industry 4.0 approach to supply chain processes and efficiencies through digital transformation is more imperative than ever before. How critical is Industry 4.0 to your business? Consider that (...)

Más detalles »
Cerrar

Jue 24 de Septiembre de 2020

Current Bacterial Endotoxins Test (BET) and its Intended Use

16:00 - 17:00 hs GMT+1

Current Bacterial Endotoxins Test (BET) and its Intended Use

Fecha

Jue 24-Set-2020, 16:00 - 17:00 hs GMT+1

Descripción

Presented by Karen Zink McCullough, Owner, Principal Consultant at MMI Associates

Más detalles »
Cerrar
Data Disruptors Webcast: Tesisquare

16:00 - 17:00 hs GMT+1

Data Disruptors Webcast: Tesisquare

Fecha

Jue 24-Set-2020, 16:00 - 17:00 hs GMT+1

Descripción

Data Disruptors Webcast: Tesisquare

Más detalles »
Cerrar
¿Por qué fracasa un proyecto ERP?

16:00 - 17:00 hs GMT+1

¿Por qué fracasa un proyecto ERP?

Fecha

Jue 24-Set-2020, 16:00 - 17:00 hs GMT+1

Descripción

Dennis Russeau nos explicará por qué puede fracasar un proyecto ERP.

Más detalles »
Cerrar
A Third-Party Risk Management Masterclass

19:00 - 20:00 hs GMT+1

A Third-Party Risk Management Masterclass

Fecha

Jue 24-Set-2020, 19:00 - 20:00 hs GMT+1

Descripción

TBC

Más detalles »
Cerrar
[Earn CPE] A Third-Party Risk Management Masterclass

19:00 - 20:00 hs GMT+1

[Earn CPE] A Third-Party Risk Management Masterclass

Fecha

Jue 24-Set-2020, 19:00 - 20:00 hs GMT+1

Descripción

TBC

Más detalles »
Cerrar

y 3 webinars más

Vie 25 de Septiembre de 2020

Sáb 26 de Septiembre de 2020

Dom 27 de Septiembre de 2020

Lun 28 de Septiembre de 2020

Strategies to Overcome Low Endotoxin Recovery Using the Conventional LAL Assay

10:00 - 11:00 hs GMT+1

Strategies to Overcome Low Endotoxin Recovery Using the Conventional LAL Assay

Fecha

Lun 28-Set-2020, 10:00 - 11:00 hs GMT+1

Descripción

Presented by Dr. Ruth Daniels, Senior Scientist - Microbiology Expert at Janssen This webinar presentation will discuss: • Endotoxin hold time studies to identify LER • In silico assessment of interfering factors and associated LER mitigation strategies • Case study: optimization of product-specific LAL assay (...)

Más detalles »
Cerrar
Strategies to Overcome Low Endotoxin Recovery Using the Conventional LAL Assay

10:00 - 11:00 hs GMT+1

Strategies to Overcome Low Endotoxin Recovery Using the Conventional LAL Assay

Fecha

Lun 28-Set-2020, 10:00 - 11:00 hs GMT+1

Descripción

Presented by Dr. Ruth Daniels, Senior Scientist - Microbiology Expert at Janssen This webinar presentation will discuss: • Endotoxin hold time studies to identify LER • In silico assessment of interfering factors and associated LER mitigation strategies • Case study: optimization of product-specific LAL assay (...)

Más detalles »
Cerrar

Mar 29 de Septiembre de 2020

OPEX EUROPE 2020. Conferencia online. Día 1

10:00 - 16:00 hs GMT+1

OPEX EUROPE 2020. Conferencia online. Día 1

Fecha

Mar 29-Set-2020, 10:00 - 16:00 hs GMT+1

Descripción

Conferencia Online de 3 días, en inglés, organizada por la asociación Process Excellence Network. Participan varios clientes de banca, seguros y alimentación explicando sus proyectos de automatización y BPM en tiempos complicados como los actuales.

Más detalles »
Cerrar
Mendix, plataforma Low Code para usuarios de negocio: Intro y demo

11:00 - 12:00 hs GMT+1

Mendix, plataforma Low Code para usuarios de negocio: Intro y demo

Fecha

Mar 29-Set-2020, 11:00 - 12:00 hs GMT+1

Descripción

Siemens Digital Industries ha incorporado a su portfolio Mendix, una plataforma de desarrollo Low Code de aplicaciones, con templates para SAP e IBM, y que permite a usuarios de negocio de todos los sectores desarrollar aplicaciones de negocio sin necesidad (...)

Más detalles »
Cerrar

Mié 30 de Septiembre de 2020

OPEX EUROPE 2020. Conferencia online. Día 2

10:00 - 16:00 hs GMT+1

OPEX EUROPE 2020. Conferencia online. Día 2

Fecha

Mié 30-Set-2020, 10:00 - 16:00 hs GMT+1

Descripción

Conferencia Online de 3 días, en inglés, organizada por la asociación Process Excellence Network. Participan varios clientes de banca, seguros y alimentación explicando sus proyectos de automatización y BPM en tiempos complicados como los actuales.

Más detalles »
Cerrar

Jue 01 de Septiembre de 2020

Vie 02 de Septiembre de 2020

Dell & NVIDIA AI Partner Champions Program 8

12:00 - 13:00 hs GMT+1

Dell & NVIDIA AI Partner Champions Program 8

Fecha

Vie 2-Set-2020, 12:00 - 13:00 hs GMT+1

Descripción

Dell & NVIDIA AI Partner Champions Program 8

Más detalles »
Cerrar
Dell & NVIDIA AI Partner Champions Program 8

12:00 - 13:00 hs GMT+1

Dell & NVIDIA AI Partner Champions Program 8

Fecha

Vie 2-Set-2020, 12:00 - 13:00 hs GMT+1

Descripción

Dell & NVIDIA AI Partner Champions Program 8

Más detalles »
Cerrar
The Impact on Using Rapid Methods For Environmental Monitoring

16:00 - 17:00 hs GMT+1

The Impact on Using Rapid Methods For Environmental Monitoring

Fecha

Vie 2-Set-2020, 16:00 - 17:00 hs GMT+1

Descripción

Presented by Dr. Michael J. Miller, President of Microbiology Consultants, LLC

Más detalles »
Cerrar

y 1 webinar más

Sáb 03 de Septiembre de 2020

Case Study: Fully Utilizing Closed Systems in Modern BioPharma Facilities

16:00 - 17:00 hs GMT+1

Case Study: Fully Utilizing Closed Systems in Modern BioPharma Facilities

Fecha

Sáb 3-Set-2020, 16:00 - 17:00 hs GMT+1

Descripción

Presented by Lars Hovmand-Lyster, Senior Engineering Specialist in Novo Nordisk Global Project Office (GPO) Engineering Management Department • Build the roadmap to biopharmaceutical manufacturing and their partners in developing, assessing and verifying unit operations leading to an appropriate facility design that is “right (...)

Más detalles »
Cerrar
Industria 4.0 en la protección de equipos mineros

17:00 - 18:00 hs GMT+1

Industria 4.0 en la protección de equipos mineros

Fecha

Sáb 3-Set-2020, 17:00 - 18:00 hs GMT+1

Descripción

La Industria 4.0 abre nuevos horizontes en prácticamente todas las áreas del conocimiento, tanto científico como aplicado. En el caso de las ciencias de materiales, las diferentes protecciones que se desarrollan para las maquinarias mineras buscan disminuir sus costos operacionales (...)

Más detalles »
Cerrar

Dom 04 de Septiembre de 2020

Quantification and Control of Amorphous contents by Raman, Application and Case

16:00 - 17:00 hs GMT+1

Quantification and Control of Amorphous contents by Raman, Application and Case

Fecha

Dom 4-Set-2020, 16:00 - 17:00 hs GMT+1

Descripción

Full Title: Quantification and Control of Amorphous contents by Raman, Application and Case Studies in Pharmaceutical Processing Presented by Michelle Raikes, M.S., Scientist IV and Dr. Fredrik Nordstrom, Sr Research Fellow at Boehringer Ingelheim Amorphous regions in crystalline material can have significant (...)

Más detalles »
Cerrar