Cell Bank Establishment & Testing - US edition MasterClass
24-25 October, 2023
This online masterclass will address regulatory requirements related to cell bank establishment and testing.
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.
24-25 October, 2023, Virtual
Time Zone: Eastern Standard Time (EST) / UTC−05:00
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 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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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
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