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ATMP Makers Encouraged To Consult Local Regulators On Compliance with EU GMP Guidelines

 
• By Eliza Slawther

Cell and gene therapy manufacturers based in Europe should speak to local regulators to understand how to demonstrate compliance with EU-level good manufacturing practice guidelines, as each country will apply the rules differently, an expert explains.

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Compliance with GMP is crucial for ATMP manufacturers (Shutterstock)

An increasing number of advanced therapy medicinal products (ATMPs) are entering the market, with the world’s first gene editing therapy, Vertex Pharmaceuticals/CRISPR Therapeutics’ Casgevy (exagamglogene autotemcel), gaining both UK and EU approval within the past year.

Compliance with good manufacturing practice (GMP) guidelines is crucial for ATMP manufacturers, but meeting expectations will require companies to understand...

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