Cell Bank Establishment & Testing In-House Training

This in-house training will address potential issues encountered when establishing cell banks and will discuss operational aspects for ensuring good quality cell banks.

This in-house training will address potential issues encountered when establishing cell banks and will discuss operational aspects for ensuring good quality cell banks.

Key learnings

Understand

Understand the regulatory requirements related to cell bank establishment and testing.

Prevent Risk

Understand how to prevent risk of viral contamination when manipulating mammalian cells.

Avoid Issues

How to avoid quality and reproducibility issues when establishing the master cell banks.

Analytical Methods

Understand alternative analytical methods for safety testing of cell banks.

Potential Issues

Understand potential issues encountered when establishing cell banks.

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Overview

The Cell Bank In-house training 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 Cell bank is one element of the cell bank system which comprises also the Working Cell Banks (WCB) and the End-of-Production Cell Bank (EoPCB).

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Trainer

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.

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.

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Who should attend img RECOMMENDATION

Who should attend?

Process development scientists and managers

CMC development program managers

Manufacturing managers and operators

Quality Assurance representatives

Regulatory Affairs representatives

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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 its 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.

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