PharmaLex has extensive experience providing support to companies that are involved in the manufacture of ATMPs. Whether it is help navigating the Regulatory landscape, giving scientific advice, support in facility design and qualification, or consultancy in analytical development, their experts have over 15  years of industry experience available. As we all know, analytical development when working with ATMPs is not as straight forward as with more “traditional” pharmaceutical products. The article below gives a little insight from typical challenges that two of the PharmaLex consultants have come across and offers some points to consider.