Automating the final cell therapy bioprocess step for robust CMC/GMP compliance
Sponsor
In many disciplines, the need for automation grows as business evolves. In cell and gene therapy, your need for automation also grows at each stage of production.
When it’s time to automate, you must consider several aspects of your manufacturing process, including quality, regulatory requirements and cost-effectiveness. GMP compliance is by far the most important: if you manage your costs but don’t meet regulations, or if you fail at quality, your product will never be released by competent authorities. In other words, there is no escape from GMP compliance.
GMP compliance is important for the entire manufacturing process, but especially at the end: your ATMP must follow guidance, and any mistake or lack of evidence can block you and waste your time and money.
In this webinar, Terumo Blood and Cell Technologies will talk about regulatory considerations and requirements for GMP compliance, the inspection approach taken by the MHRA, and some considerations companies may want to take into account within their own facilities at the fill/finish stage. The presentation will be followed by a discussion of the risks posed by the fill and finish step, and the role of automation in helping to mitigate them.
- Why GMP compliance must be central to the planning of your manufacturing process.
- How to identify specific gaps in compliance that may occur during the fill and finish process.
- How automating final formulation, fill and finish helps alleviate those pain points.
SPEAKERS
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