Advanced therapy medicinal products (ATMPs), which include cell and gene therapy (C>) products, frequently require handling steps between quality control release and patient administration. These steps take place directly at the point of care and are especially critical for C>s with limited shelf life after preparation.
Cell and gene therapy (C>) products address various diseases at the cellular or genetic level, offer innovative treatment approaches, and represent a significant advancement in the field of medicine. However, developers of C> products face unique challenges due to their complexity, such as establishing assays that show a clear link between potency, mechanism of action (MoA), and...
This article offers an overview of the benefits of Pharmaceutical Inspection Co-operation Scheme (PIC/S) membership for regulatory authorities and industry. It also highlights Latin American regulators’ current perspectives on PIC/S membership to increase awareness and encourage open dialogue about harmonization, recognition agreements, and potential increase for export facilitation, all which...
Cell and gene therapy (C>) products represent a significant step forward in patient treatment and often offer unique patient benefits. However, product developers face significant hurdles within the regulatory landscape. The tools laid out in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q12 guideline: “Technical and...
In the beautiful city of Barcelona, Spain, ISPE will host members, vendors, pharmaceutical companies, consulting firms, and design companies for the 2023 ISPE Pharma 4.0™ and Annex 1 Conference on...
