Good manufacturing practice

Performance-Based Exposure Control Limits for Pharmaceutical Active Ingredients

Bruce D. Naumann, Edward V. Sargent, Barry S. Starkman, William J. Fraser, Gail T. Becker, G. David Kirk

Citations: 151 • 1996

Robotic cell processing facility for clinical research of retinal cell therapy

Motoki Terada, Yumiko Shibata, Michinori Kitagawa, S. Kato, Tomomitsu Iida, Tsuyoshi Yorimitsu, Akari Kato, Kenji Matsukuma, Tadao Maeda, Masayo Takahashi, Genki N. Kanda

Citations: 14 • 2023

From Single Batch to Mass Production–Automated Platform Design Concept for a Phase II Clinical Trial Tissue Engineered Cartilage Product

Sebastian Haeusner, Laura Herbst, Patrick Bittorf, Thomas Schwarz, Chris Henze, Marc Mauermann, Jelena Ochs, Robert Schmitt, Ulrich Blache, Anke Wixmerten, Sylvie Miot, Iván Martín, Oliver Pullig

Citations: 13 • 2021

Analytical validation in practice at a quality control laboratory in the Japanese pharmaceutical industry

S. Seno, S. Ohtake, H. Kohno

Citations: 12 • 1997