Real-time product attribute control to manufacture antibodies with defined N-linked glycan levels

A robust method for increasing Fc glycan high mannose level of recombinant antibodies

(2015) Chung-Jr Huang et al.   BIOTECHNOLOGY AND BIOENGINEERING

The criticality of high-resolution N-linked carbohydrate assays and detailed characterization of antibody effector function in the context of biosimilar development

(2015) Lowell J Brady et al.   mAbs

Understanding Pharmaceutical Quality by Design

(2014) Lawrence X. Yu et al.   AAPS Journal

Use of a small molecule cell cycle inhibitor to control cell growth and improve specific productivity and product quality of recombinant proteins in CHO cell cultures

(2014) Zhimei Du et al.   BIOTECHNOLOGY AND BIOENGINEERING

Cell culture media supplementation of uncommonly used sugars sucrose and tagatose for the targeted shifting of protein glycosylation profiles of recombinant protein therapeutics

(2014) Patrick Hossler et al.   BIOTECHNOLOGY PROGRESS

Manganese increases high mannose glycoform on monoclonal antibody expressed in CHO when glucose is absent or limiting: Implications for use of alternate sugars

(2014) Tanaya Surve et al.   BIOTECHNOLOGY PROGRESS

Production, characterization and pharmacokinetic properties of antibodies with N-linked Mannose-5 glycans

(2012) Marcella Yu et al.   mAbs

Process analytical technology (PAT) for biopharmaceuticals

(2011) Jarka Glassey et al.   Biotechnology Journal

High-mannose glycans on the Fc region of therapeutic IgG antibodies increase serum clearance in humans

(2011) A. M. Goetze et al.   GLYCOBIOLOGY

Optimal and consistent protein glycosylation in mammalian cell culture

(2009) P. Hossler et al.   GLYCOBIOLOGY

Quality by design for biopharmaceuticals

(2009) Anurag S Rathore et al.   NATURE BIOTECHNOLOGY

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

(2008) Lawrence X. Yu   PHARMACEUTICAL RESEARCH