Characterization of a Monoclonal Antibody Cell Culture Production Process Using a Quality by Design Approach

Effect of Copper Sulfate on Performance of a Serum-Free CHO Cell Culture Process and the Level of Free Thiol in the Recombinant Antibody Expressed

Wendy B. Chaderjian, Edward T. Chin, Reed J. Harris et al. · Biotechnology Progress · 2005 · 117 citations

Pharmacy, Biochemistry, Biotechnology +17

Can pharmaceutical process development become high tech?

Paul McKenzie, San Kiang, Jean W. Tom et al. · AIChE Journal · 2006 · 105 citations

Pharmacy, Chemical Engineering, Pharmaceutical Manufacturing +13

Quality-by-Design (QbD): Effects of Testing Parameters and Formulation Variables on the Segregation Tendency of Pharmaceutical Powder Measured by the ASTM D 6940-04 Segregation Tester

Lin Xie, Huiquan Wu, Meiyu Shen et al. · Journal of Pharmaceutical Sciences · 2008 · 51 citations

Pharmacy, Pharmaceutical Analysis, Pharmaceutical Formulation +9

A systematic approach to the validation of process control parameters for monoclonal antibody production in fed-batch culture of a murine myeloma

Enda Moran, Steve T. McGowan, John McGuire et al. · Biotechnology and Bioengineering · 2000 · 49 citations

Pharmacy, Biotechnology, Immunology +16