Cell Bank Establishment & Testing MasterClass - US edition
21-22 October, 2024
Master Cell Bank is not only the starting point of GMPs but also the starting point of the manufacturing process of therapeutical recombinant
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).
21-22 October, 2024, Virtual
Starting Time: EDT 11:00 a.m. | PDT 08:00 a.m. | UTC 15:00 p.m. | CET 17:00 p.m
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.
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antibodies using proprietary chemically-defined cell culture media and feeds. After our participation to the FDAs 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.
RECOMMENDATION
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 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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