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Process Scale-up

Process Scale-up

Tech Transfer: Planning for Success

Tech Transfers, or Technology Transfers, usually imply that you’re moving the manufacture of a drug from one facility, one scale or one drug lifecycle phase to another. Which is why they are so important. When you switch facilities, you want to transfer the knowledge and reproduce the process smoothly. The Read more…

By 4TE Team, 11 monthsJune 16, 2021 ago
Comparability Studies

Comparability for Post-Approval Changes

Today we want to take a fresh look into comparability for post-approval changes. How? We’re thinking of a unique multiparametric approach. This approach is aligned with the FDA’s tiered and totality-of-evidence concepts in biologic development. These concepts are helpful to compare biosimilar and reference products. But they can go beyond Read more…

By 4TE Team, 11 monthsJune 13, 2021 ago
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4Tune Engineering provides 4.0 Intelligent & Integrated solutions to support Pharma and Biopharma Industries' Digital Transformation. Focused on operational excellence, we assist companies improve decisively the entire life cycle of their products and processes. Founded in 2004 with offices in Lisbon and São Paulo.




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