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2023 Aseptic Conference

SES203a - Best Possible Annex 1 Compliance of Single-Use for ATMPs

‐ Mar 7, 2023 12:30pm

One of the most frequent asked question is, how to get things inside an Isolator without breaking the sterile barrier, how to protect the product but also the operators from certain substances the best possible way.

In pharma manufacturing, all is based on identifying and evaluating critical factors. Initially for the project, but also later in daily processes. It’s all about risks. Cross contamination prevention, risks for the products, but also risk for the operators.

There’s also the price of the drugs, the manufacturing costs, and the batch size. The costs inevitably lead to the question of how to avoid product loss, in other words how to get as much as product to the point of fill by achieving best possible product recovery rates and filling accuracy.

Why does single-use and ready-to-use best possibly comply to EU GMP Annex 1 Why does single-use especially make sense in dealing with new types of medicinal products like ATMPs and ADCs.

What are market standards and trends and where is pharma manufacturing moving to.


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