Contamination Control Strategies for ATMP Manufacturing: A PharmaLex Perspective

Advanced Therapy Medicinal Products (ATMPs) represent a novel class of complex biological products that are at the forefront of scientific innovation and hold great potential to improve health care. To ensure that appropriate measures are put in place by the manufacturers to safeguard the quality of the product, all ATMPs produced for human use from clinical Phase I onward must comply with current Good Manufacturing Practice (cGMP) regulations