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Novel Biopharma: What Lies Ahead?

Elena Meurer, Principal Consultant And CMC Expert, Looks At Manufacturing And Quality Implications For Advanced Therapies

Executive Summary

Advanced Therapies have come a long way over the past decade. Some cell and gene therapies have already been approved and others have now entered the later stages of development and this is reflected in a shift towards later clinical trials. In consequence, manufacturing process consistency, GMP standards, etc., must now meet more formal requirements. This brings some challenges because the products, and their development and manufacturing processes, differ from traditional models.

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