Recently, the FDA has given its approval to Roctavian from BioMarin Pharmaceutical Inc. It is an adeno-associated virus vector-based gene therapy intended to treat adults who have severe Hemophilia A…
In the development of an Advanced Therapy Medicinal Product (ATMP) involving the donation of human tissues or cells to be used as starting materials, the control of the materials, traceability,…
Today, from Revio, we would like to share with you a review of the Industry Guidance on manufacturing of cellular and gene therapy products (CGT) authorised by the Food and…
Today, from Revio, we would like to share with you a summary of the main aspects mentioned in the EMA ‘’Reflection paper on stem cell-based medicinal products’’ (EMA/CAT/571134/2009) which may…
In January 2018 the EMA released for consultation the Guideline on safety and efficacy follow-up and risk management of Advanced Therapy Medicinal Products (Rev.1). This guideline is still in draft…
Challenges to design and conduct ATMP trials Manufacturing constraints and short shelf-life may require the implementation of tight controls on logistical arrangements. Mode of application may imply difficulties in the…
ATMPs classification procedure There is a “Reflection paper on classification of advanced therapy medicinal products” (21 May 2015, EMA/CAT/600280/2010 rev.1) with the aim of: Providing guidance on the ATMPs classification…
Revio is a Regulatory Affairs Consultancy – Created to support biopharmaceutical companies and public institutions, working with Advanced Therapy Medicinal Products (ATMPs)