Development of a quantitative mass spectrometry multi-attribute method for characterization, quality control testing and disposition of biologics

An optimized approach to the rapid assessment and detection of sequence variants in recombinant protein products

(2015) Lowell J. Brady et al.   ANALYTICAL AND BIOANALYTICAL CHEMISTRY

Implementing quality by design for biotech products: Are regulators on track?

(2015) Francesca Luciani et al.   mAbs

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

Towards real-time monitoring of therapeutic protein quality in mammalian cell processes

(2014) Daniel A.M. Pais et al.   CURRENT OPINION IN BIOTECHNOLOGY

LC-MS/MS Peptide Mapping with Automated Data Processing for Routine Profiling of N-Glycans in Immunoglobulins

(2014) Bhavana Shah et al.   JOURNAL OF THE AMERICAN SOCIETY FOR MASS SPECTROMETRY

What's fueling the biotech engine—2012 to 2013

(2014) Saurabh (Rob) Aggarwal   NATURE BIOTECHNOLOGY

Biopharmaceutical benchmarks 2014

(2014) Gary Walsh   NATURE BIOTECHNOLOGY

G/U and Certain Wobble Position Mismatches as Possible Main Causes of Amino Acid Misincorporations

(2013) Zhongqi Zhang et al.   BIOCHEMISTRY

Profiling the effects of process changes on residual host cell proteins in biotherapeutics by mass spectrometry

(2013) Matthew R. Schenauer et al.   BIOTECHNOLOGY PROGRESS

Applications of capillary electrophoresis in characterizing recombinant protein therapeutics

(2013) Shuai Sherry Zhao et al.   ELECTROPHORESIS

Modern chromatographic and mass spectrometric techniques for protein biopharmaceutical characterization

(2013) Koen Sandra et al.   JOURNAL OF CHROMATOGRAPHY A

Antibodies to watch in 2014

(2013) Janice M Reichert   mAbs

Quality by Design Approach: Application of Artificial Intelligence Techniques of Tablets Manufactured by Direct Compression

(2012) Buket Aksu et al.   AAPS PHARMSCITECH

Characterization of Therapeutic Antibodies and Related Products

(2012) Alain Beck et al.   ANALYTICAL CHEMISTRY

Analytical lessons learned from selected therapeutic protein drug comparability studies

(2012) Marcia Federici et al.   BIOLOGICALS

Strategic funding priorities in the pharmaceutical sciences allied to Quality by Design (QbD) and Process Analytical Technology (PAT)

(2012) Buket Aksu et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Advances and challenges in analytical characterization of biotechnology products: Mass spectrometry-based approaches to study properties and behavior of protein therapeutics

(2011) Igor A. Kaltashov et al.   BIOTECHNOLOGY ADVANCES

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

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

The problems with today's pharmaceutical business—an outsider's view

(2011) Mark Kessel   NATURE BIOTECHNOLOGY

Large-Scale Identification and Quantification of Covalent Modifications in Therapeutic Proteins

(2009) Zhongqi Zhang   ANALYTICAL CHEMISTRY

Quality by design for biopharmaceuticals

(2009) Anurag S Rathore et al.   NATURE BIOTECHNOLOGY

Recombinant antibody therapeutics: the impact of glycosylation on mechanisms of action

(2009) Royston Jefferis   TRENDS IN PHARMACOLOGICAL SCIENCES

Separation of populations of antibody variants by fine tuning of hydrophobic-interaction chromatography operating conditions

(2008) John Valliere-Douglass et al.   JOURNAL OF CHROMATOGRAPHY A