David J Williams, Richard Archer, Peter Archibald, Ioannis Bantounas, Ricardo Baptista, Roger Barker, Jacqueline Barry, Florence Bietrix, Nicholas Blair, Julian Braybrook, Jonathan Campbell, Maurice Canham, Amit Chandra, Gabor Foldes, Rudy Gilmanshin, Mathilde Girard, Erwin Gorjup, Zöe Hewitt, Paul Hourd, Johan Hyllner, Helen Jesson, Jasmin Kee, Julie Kerby, Nina Kotsopoulou, Stanley Kowalski, Chris Leidel, Damian Marshall, Louis Masi, Mark McCall, Conor McCann, Nicholas Medcalf, Harry Moore, Hiroki Ozawa, David Pan, Malin Parmar, Anne L Plant, Yvonne Reinwald, Sujith Sebastian, Glyn Stacey, Robert J Thomas, Dave Thomas, Jamie Thurman-Newell, Marc Turner, Loriana Vitillo, Ivan Wall, Alison Wilson, Jacqueline Wolfrum, Ying Yang, Heiko Zimmerman
This paper summarizes the proceedings of a workshop held at Trinity Hall, Cambridge to discuss comparability and includes additional information and references to related information added subsequently to the workshop. Comparability is the need to demonstrate equivalence of product after a process change; a recent publication states that this 'may be difficult for cell-based medicinal products'. Therefore a well-managed change process is required which needs access to good science and regulatory advice and developers are encouraged to seek help early...
July 2016: Regenerative Medicine