FDA reorganization: a “Super Office” to manage the increasing cell and gene therapy workload
Advanced Therapy Medicinal Products (ATMPs) are biological drugs potentially capable to defeat several pathologies considered untreatable, for example exploiting the...
GMP Cleanliness Classifications: Deciphering the Differences and Requirements among Grades
Working with biological drugs or with other sterile medications is an extremely complex task. For this reason, regulators worldwide established...
Somatic Cell Therapy Medicinal Products, Definition from a Regulatory Standpoint
Stem cells are naturally producing cells in the body; interestingly they are able to develop into several different types. They...
The Concept of Decontamination, Disinfection, and Sterilization in the cGMP Framework
Advanced Therapies Medicinal Products (ATMPs) are medicines or drugs based on cells or gene therapies. In order not to alter...
Clinical Trials Regulation: a new European Bureaucratic System to Improve Clinical Applications
Clinical trials are defined by EMA as “studies performed to investigate the safety or efficacy of a medicine. For human...
SCADA control guidelines in a nutshell
The Supervisory Control and Data Acquisition, commonly known as SCADA, is a control system architecture comprised of a workstation connected...
Bureaucratic difficulties in the ATMPs manufacturing: to significant examples of regulatory misleading
Advanced Therapy Medicinal Products (ATMPs), represent a fast-growing group of innovative biological medications, with stunning potential for the treatment of...