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When transitioning ATMPs from R&D to current cGMP production you are likely to face several challenges. Many of the common pitfalls can be avoided with thoughtful consideration of your equipment needs. Kris Wronski, Cell Culture Applications Scientist from Thermo Fisher Scientific, will discuss critical considerations for effective lab equipment implementation into a cGMP and cleanroom environment. Including:
- Understanding the unique cGMP compliance framework and challenges for advanced therapy medicinal products (ATMPs).
- The impact of lab equipment on contamination prevention and safety of therapy products.
- The crucial factors to consider for lab equipment when moving into cleanroom production.
- The importance of correct documentation for cleanroom compatibility and an effective qualification process.
- The role of equipment design in achieving consistent performance and reproducible results.