Quality by design for biopharmaceuticals

Pharmaceutical Quality by Design: Product and Process Development, Understanding, and Control

Lawrence X. Yu · Pharmaceutical Research · 2008 · 1.2K citations

Pharmacy, Pharmaceutics, Pharmacy Practice +14

Recommendations for the design and optimization of immunoassays used in the detection of host antibodies against biotechnology products

Anthony R. Mire‐Sluis, Yu Chen Barrett, Viswanath Devanarayan et al. · Journal of Immunological Methods · 2004 · 621 citations

Life Sciences, Biotechnology, Immunology +13

Process Analytical Technology (PAT): Batch-to-batch reproducibility of fermentation processes by robust process operational design and control

Stefan Gnoth, Marco Jenzsch, Rimvydas Simutis · Journal of Biotechnology · 2007 · 126 citations

Engineering, Biotechnology, Chemical Engineering +17

Case study and application of process analytical technology (PAT) towards bioprocessing: Use of on‐line high‐performance liquid chromatography (HPLC) for making real‐time pooling decisions for process chromatography

Anurag S. Rathore, Marcella Yu, Samuel O. Yeboah et al. · Biotechnology and Bioengineering · 2007 · 124 citations

Life Sciences, Chemical Engineering, Pharmaceutical Analysis +17

Defining Process Design Space for Biotech Products: Case Study of <i>Pichia pastoris</i> Fermentation

Jean Harms, Xiangyang Wang, Tina Kim et al. · Biotechnology Progress · 2008 · 100 citations · Full text

Life Sciences, Bioengineering, Biotechnology +17