Cell Bank Establishment & Testing MasterClass - US edition

02-03 September, 2024

This online masterclass will address regulatory requirements related to cell bank establishment and testing.

Cell Bank Establishment & Testing MasterClass - US edition

The Master Cell Bank (MCB) is not only the starting point of GMPs (in accordance with ICH Q11) but it is also the starting point of the manufacturing process of therapeutical recombinant proteins and gene therapy products.

 

02-03 September, 2024, Virtual
Time Zone: Eastern Daylight Time (EDT) - UTC−04:00

GET THE AGENDA NOW

Pharma Online MasterClass

Overview

 

The Master Cell Bank (MCB) is not only the starting point of GMPs (in accordance with ICH Q11) but it is also the starting point of the manufacturing process of therapeutical recombinant proteins and gene therapy products. The MCB is one element of the cell bank system which comprises also the Working Cell Banks (WCB) and the End-of-Production Cell Bank (EoPCB).

The qualification of the cell bank system, which comprises identity testing, phenotypic & genotypic characterization, and safety testing, is a principal component that ensures process performance and reproducibility, the quality of the end product and is one element of preventive measures to prevent potential safety issues for the patients.

The Master Class will also address potential issues encountered when establishing cell banks and will discuss operational aspects for ensuring good quality cell banks.

#masterclass     #glceurope      #pharmaonlinetraining      #globalleadingconferences       #cellbankestablishment

Trainer
Myléne Talabardon
Myléne Talabardon
With over 20 years of experience in the pharmaceutical industry, Mylène has a strong experience in process development, technology transfer and process validation. She obtained her PhD in biotechnology from The Ohio State University and her environmental engineering degree from the Swiss Federal Institute of Technology (EPFL). In 2001, she joined BiogenIdec in cell culture process department, focusing on antibody production from lab scale to manufacturing scale.
Hervé Broly
Hervé Broly
Starting with an engineering degree in agriculture, followed by a PhD in plant physiology, I joined the Blood Transfusion Center (Lille, France) in 1982 where I implemented a unit for the development and manufacture of monoclonal antibodies against blood groups, blood proteins and viral antigens. In 1991, I took the position of Head of Process Development and Manufacturing at Sorebio (Martillac, France), a contract manufacturing organization specialized in the development and manufacture of monoclonal antibodies for clinical development. I took the lead of that company in 1998 after it was bought by Serono, a Swiss biotech company (Geneva, Switzerland) in 1994. In 2003, I moved to Serono in Geneva as Global Product Team Leader in charge of managing the development of a recombinant Ig-fusion protein for the treatment of autoimmune diseases, moving that product from Phase I to Phase III. As of November 2006, I’ve been appointed Vice-President, Head of Biotech Process Sciences at MerckSerono, based in Vevey, Switzerland, in charge of developing and validating the manufacturing processes for biotechnological products. In that context, whereas Serono was mainly using perfusion processes for recombinant hormones and cytokines, we moved the company to large-scale manufacture of monoclonal
antibodies using proprietary chemically-defined cell culture media and feeds. After our participation to the FDA’s pilot program on Quality by Design, the concepts described in ICH Q8(R2) and ICH Q11 were implemented in our approach to gain process understanding. It was concluded by issuing a modernized approach for process validation at Merck (Darmstadt, Germany). More recently, we have introduced advanced processes such as intensified fed-batch and continuous downstream processing.

Who should attend imgRECOMMENDATION

Who should attend?


• Process development scientists and managers
• CMC development program managers
• Manufacturing managers and operators
• Quality Assurance representatives
• Regulatory Affairs representatives

Testimonial

Our success stories

"High attention to detail in course content and very well delivered"

Simon Halsey
Product Development Manager
Essentra Packaging
United Kingdom

Our success stories

"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"

Aurelie Vivicorsi
USP PD Team Manager
Celonic AG
Switzerland

Our success stories

"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"

Emilia Szwej
Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany

About GLC

Global Leadership Conferences began as an ambitious dream by three founders ten years ago. Today it’s an international series of interactive events, exploring the hottest topics in critical fields. Each year, thousands of professionals join us to challenge the status quo and learn innovative ways to create new solutions in Finance, Pharmaceutical, HR, Health & Safety, and Energy.

know more >

12+

Years of experience

399

Events organized

3,710

Speakers

21,521

Attendees

REQUEST AGENDA FORM
Download Full Agenda
Get the agenda now for additional information, detailed program and pricing

Name
Corporate email
Corporate phone
From where did you hear about the event?
Name of the GLC Representative (optional)
10+ participants interested from my team
E-mail consent
Privacy Policy

Other events you may like

Adaptive Design in Clinical Trials MasterClass – EU edition

Adaptive Design in Clinical Trials MasterClass – EU edition

17-18 June, 2024

Principles, advantages and potential challenges of the adaptive design methodology

12+

Years of experience

399

Events organized

3,710

Speakers

21,521

Attendees

You’re in good company

deutsche bank logo e on logo kpmg logo merck logo roche logo siemens logo

Testimonial

Our success stories

"High attention to detail in course content and very well delivered"

Simon Halsey
Product Development Manager
Essentra Packaging
United Kingdom

Our success stories

"Very good training led by two knowledgeable and open experts. Excellent insight given on many complex topics. Interactive and highly useful"

Aurelie Vivicorsi
USP PD Team Manager
Celonic AG
Switzerland

Our success stories

"Great course, impressed with the knowledge of the trainers and ability to answer wide variety of questions!"

Emilia Szwej
Manager, Senior Investigator
MT Sword Laboratories (BMS)
Germany

Are you a registered client?

If you have questions, please reach us at

help@glceurope.com