Application of quality by design principles to the development and technology transfer of a major process improvement for the manufacture of a recombinant protein

Defining process design space for a hydrophobic interaction chromatography (HIC) purification step: Application of quality by design (QbD) principles

(2010) Canping Jiang et al.   BIOTECHNOLOGY AND BIOENGINEERING

Defining process design space for monoclonal antibody cell culture

(2010) Susan Fugett Abu-Absi et al.   BIOTECHNOLOGY AND BIOENGINEERING

Towards the implementation of quality by design to the production of therapeutic monoclonal antibodies with desired glycosylation patterns

(2010) Ioscani Jimenez del Val et al.   BIOTECHNOLOGY PROGRESS

Quality by design for biopharmaceuticals

(2009) Anurag S Rathore et al.   NATURE BIOTECHNOLOGY

Micro biochemical engineering to accelerate the design of industrial-scale downstream processes for biopharmaceutical proteins

(2008) N.J. Titchener-Hooker et al.   BIOTECHNOLOGY AND BIOENGINEERING

Defining Process Design Space for Biotech Products: Case Study of Pichia pastoris Fermentation

(2008) J. Harms et al.   BIOTECHNOLOGY PROGRESS

Bioprocess optimization using design-of-experiments methodology

(2008) Carl-Fredrik Mandenius et al.   BIOTECHNOLOGY PROGRESS

PQLI Definition of Criticality

(2008) Roger Nosal et al.   Journal of Pharmaceutical Innovation

PQLI Engineering Controls and Automation Strategy

(2008) Ray Bolton et al.   Journal of Pharmaceutical Innovation

PQLI Design Space

(2008) John Lepore et al.   Journal of Pharmaceutical Innovation

PQLI Control Strategy Model and Concepts

(2008) Bruce Davis et al.   Journal of Pharmaceutical Innovation

PQLI Key Topics - Criticality, Design Space, and Control Strategy

(2008) Thomas Garcia et al.   Journal of Pharmaceutical Innovation