Viral Safety of ATMPs

Dear Colleagues,

On behalf of the Program Planning Committee and the Parenteral Drug Association, we are pleased to invite you to the 2016 PDA Europe Viral Safety of ATMPs to be held in Berlin on 6^th of June.

This year’s PDA Europe Virus Safety Forum will specifically focus on Advanced Therapy Medicinal products (ATMPs). ATMPs provide exiting and promising new concepts for therapy. Nevertheless, designing adequate viral safety margins into the manufacturing processes of these novel products remains a challenge. ATMPs are produced using complex cell culture systems involving a variety of biological raw materials. Due to the unique nature of ATMPs, there are some limitations of applying virus safety measures. For example, it is difficult to perform conventional tests for adventitious virus contamination on non-cryo-preserved cell based medicinal products or to apply virus inactivation methods on living cells. Therefore, the use of carefully selected and well-controlled raw materials is a crucial factor for the production of ATMPs. Efforts are being made to replace bovine sera, however, providing for adequate viral safety margins of human-derived and other biological materials remains similar a challenge.

This conference will cover a broad variety of essential biological raw materials for cell-based medicinal products such as human platelet lysate or other serum replacements and materials from recombinant cell cultures such as cytokines. We will learn from exciting case studies how virus safety concepts have been successfully implemented for viral gene-transfer vectors and oncolytic viruses. The conference will further provide attendees with updates on the most recent regulatory developments.

Lunches and refreshment breaks will provide a relaxed environment to facilitate discussions of the issues raised during the day’s presentations. There will be sufficient time for visiting with vendors and networking with fellow experts and regulators. 

We look forward to seeing you in Berlin on 6^th of June 2016 for this unique opportunity!

Johannes Bluemel, PhD, Paul-Ehrlich Institute

Thomas R. Kreil, PhD, Baxalta

Conference Co-Chairs