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Efforts Mount to Assure Quality of Emerging Pharma Technologies

This article was originally published in The Gold Sheet

Executive Summary

The regulatory challenges of emerging technologies are triggering an evolution in CMC review and GMP compliance approaches as regulatory agencies, drug manufacturers and standard-setting organizations strive to adapt 20th century concepts to 21st century science. FDA unveils an initiative to close ‘regulatory science’ gaps, while EMA drafts a road map for adapting its regulatory framework to novel scientific approaches. PQRI considers opportunities to contribute its scientific expertise at the government/industry nexus. The CMC Strategy Forum explores new approaches for antibody-drug conjugates. FDA launches nanotechnology initiative; CDER’s concerns about nanoparticles shared. FDA approves first ‘biopharm’ product, prepares for wave of applications. Manufacturing quality issues with transgenic bioreactors explored in context of GTC’s goat farm. How milking animals compares to milking CHO cells. On biosimilars, U.S. legislation stalls while the EU forges ahead with reviewing applications – and Japan declares a preference for ‘bio-betters.’ Meanwhile, the science for supporting bio-comparison remains lost in the folds of higher order structure. All could be clarified by NIST’s ambitious reference standard proposal.

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