Purification of Modified Therapeutic Proteins Available on the Market: An Analysis of Chromatography-Based Strategies

Therapeutic Fc‐fusion proteins: Current analytical strategies

(2020) Bastiaan L. Duivelshof et al.   JOURNAL OF SEPARATION SCIENCE

Investigation of alkaline effects on Protein A affinity ligands and resins using high resolution mass spectrometry

(2020) Magnus Wetterhall et al.   JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Protein A chromatography: Challenges and progress in the purification of monoclonal antibodies

(2019) Ana Mayela Ramos‐de‐la‐Peña et al.   JOURNAL OF SEPARATION SCIENCE

Progress and Challenges in PEGylated Proteins Downstream Processing: A Review of the Last 8 Years

(2019) Ana Mayela Ramos-de-la-Peña et al.   International Journal of Peptide Research and Therapeutics

Pegfilgrastim-jmdb/MYL-1401H: A Pegfilgrastim Biosimilar

(2019) Sheridan M. Hoy   BIODRUGS

Emerging PEGylated non-biologic drugs

(2019) Eun Ji Park et al.   EXPERT OPINION ON EMERGING DRUGS

The Discovery and Development of Liraglutide and Semaglutide

(2019) Lotte Bjerre Knudsen et al.   Frontiers in Endocrinology

Characterization of therapeutic antibody fragmentation using automated capillary western blotting as an orthogonal analytical technique

(2019) Yunxiao Zhu et al.   ELECTROPHORESIS

Development and Characterization of PEGylated Chromatographic Monoliths as a Novel Platform for the Separation of PEGylated RNase a Isomers

(2019) Calef Sánchez-Trasviña et al.   ADVANCES IN POLYMER TECHNOLOGY

Engineering challenges in therapeutic protein product and process design

(2019) Maria M. Papathanasiou et al.   Current Opinion in Chemical Engineering

High-throughput screening and optimization of mixed-mode resins for human serum albumin separation with microtiter filter plate

(2018) Wen-Ning Chu et al.   BIOCHEMICAL ENGINEERING JOURNAL

Recent developments in chromatographic purification of biopharmaceuticals

(2018) Anurag S. Rathore et al.   BIOTECHNOLOGY LETTERS

Protein Lipidation: Occurrence, Mechanisms, Biological Functions, and Enabling Technologies

(2018) Hong Jiang et al.   CHEMICAL REVIEWS

Engineering of Fc Fragments with Optimized Physicochemical Properties Implying Improvement of Clinical Potentials for Fc-Based Therapeutics

(2018) Chunpeng Yang et al.   Frontiers in Immunology

Heparin: role in protein purification and substitution with animal-component free material

(2018) Svenja Nicolin Bolten et al.   APPLIED MICROBIOLOGY AND BIOTECHNOLOGY

The pearl necklace model in Protein A chromatography - molecular mechanisms at the resin interface

(2018) Goncalo L. Silva et al.   BIOTECHNOLOGY AND BIOENGINEERING

Chemoenzymatic Methods for the Synthesis of Glycoproteins

(2018) Chao Li et al.   CHEMICAL REVIEWS

BAX 855, a PEGylated rFVIII product with prolonged half-life

(2018) M. J. Bossard et al.   Hamostaseologie

An enhanced regeneration strategy to improve microbial control and prolong resin lifetime for Protein A resin in large-scale monoclonal antibody (mAb) purification

(2018) Tianyi Zhou et al.   JOURNAL OF BIOTECHNOLOGY

Competitive binding of monoclonal antibody monomer-dimer mixtures on ceramic hydroxyapatite

(2018) Yiran Wang et al.   JOURNAL OF CHROMATOGRAPHY A

Hindered diffusion of proteins in mixture adsorption on porous anion exchangers and impact on flow-through purification of large proteins

(2018) Alexander Matlschweiger et al.   JOURNAL OF CHROMATOGRAPHY A

Biopharmaceutical benchmarks 2018

(2018) Gary Walsh   NATURE BIOTECHNOLOGY

Enhanced anti-metastatic bioactivity of an IGF-TRAP re-engineered to improve physicochemical properties

(2018) George Vaniotis et al.   Scientific Reports

Nonclinical pharmacokinetic and pharmacodynamic characterisation of somapacitan: A reversible non-covalent albumin-binding growth hormone

(2017) Peter Thygesen et al.   GROWTH HORMONE & IGF RESEARCH

Optimized purification of mono-PEGylated lysozyme by heparin affinity chromatography using response surface methodology

(2017) Luis Alberto Mejía-Manzano et al.   JOURNAL OF CHEMICAL TECHNOLOGY AND BIOTECHNOLOGY

Mechanical characterisation of agarose-based chromatography resins for biopharmaceutical manufacture

(2017) Mauryn C. Nweke et al.   JOURNAL OF CHROMATOGRAPHY A

Manufacturing history of etanercept (Enbrel®): Consistency of product quality through major process revisions

(2017) Brian Hassett et al.   mAbs

In situ PEGylation of recombinant hirudin on an anion exchange chromatography column

(2017) Xudong Wang et al.   PROCESS BIOCHEMISTRY

Effective strategies for host cell protein clearance in downstream processing of monoclonal antibodies and Fc-fusion proteins

(2017) Yifeng Li   PROTEIN EXPRESSION AND PURIFICATION

The Market of Biopharmaceutical Medicines: A Snapshot of a Diverse Industrial Landscape

(2017) Evelien Moorkens et al.   Frontiers in Pharmacology

Formulation and PEGylation optimization of the therapeutic PEGylated phenylalanine ammonia lyase for the treatment of phenylketonuria

(2017) Sean M. Bell et al.   PLoS One

Reversed-phase separation methods for glycan analysis

(2016) Gerda C. M. Vreeker et al.   ANALYTICAL AND BIOANALYTICAL CHEMISTRY

Evaluation of eco-friendly zwitterionic detergents for enveloped virus inactivation

(2016) Lynn Conley et al.   BIOTECHNOLOGY AND BIOENGINEERING

PEGylated protein separation using different hydrophobic interaction supports: Conventional and monolithic supports

(2016) Karla Mayolo-Deloisa et al.   BIOTECHNOLOGY PROGRESS

Half-Life Extension of Biopharmaceuticals using Chemical Methods: Alternatives to PEGylation

(2016) Søren B. van Witteloostuijn et al.   ChemMedChem

Challenges of glycosylation analysis and control: an integrated approach to producing optimal and consistent therapeutic drugs

(2016) Peiqing Zhang et al.   DRUG DISCOVERY TODAY

Downstream process development strategies for effective bioprocesses: Trends, progress, and combinatorial approaches

(2016) Pascal Baumann et al.   ENGINEERING IN LIFE SCIENCES

Emerging drugs for the treatment of hemophilia A and B

(2016) Massimo Morfini et al.   EXPERT OPINION ON EMERGING DRUGS

Determinants of protein elution rates from preparative ion-exchange adsorbents

(2016) James M. Angelo et al.   JOURNAL OF CHROMATOGRAPHY A

Separation of mono- and di-PEGylate of exenatide and resolution of positional isomers of mono-PEGylates by preparative ion exchange chromatography

(2016) Ngoc-Thanh Thi Nguyen et al.   JOURNAL OF CHROMATOGRAPHY A

Separation of pegylated recombinant proteins and isoforms on CIM ion exchangers

(2016) Jernej Gašperšič et al.   JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

PEGylation of Biopharmaceuticals: A Review of Chemistry and Nonclinical Safety Information of Approved Drugs

(2016) Peter L. Turecek et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

A reactive continuous chromatographic process for protein PEGylation

(2016) Oliver Ingold et al.   Reaction Chemistry & Engineering

Model-based development of an on-column PEGylation process

(2016) David Pfister et al.   Reaction Chemistry & Engineering

Fusion Proteins for Half-Life Extension of Biologics as a Strategy to Make Biobetters

(2015) William R. Strohl   BIODRUGS

Manufacturing process used to produce long-acting recombinant factor VIII Fc fusion protein

(2015) Justin McCue et al.   BIOLOGICALS

Development and scale-up of the recovery and purification of a domain antibody Fc fusion protein-comparison of a two and three-step approach

(2015) Sibylle Herzer et al.   BIOTECHNOLOGY AND BIOENGINEERING

Advective hydrogel membrane chromatography for monoclonal antibody purification in bioprocessing

(2015) Ying Hou et al.   BIOTECHNOLOGY PROGRESS

What is the future of PEGylated therapies?

(2015) Magdalena Swierczewska et al.   EXPERT OPINION ON EMERGING DRUGS

Effect of lysozyme solid-phase PEGylation on reaction kinetics and isoform distribution

(2015) Benjamin Maiser et al.   JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Emerging drugs for hemophilia B

(2014) Pier Mannuccio Mannucci et al.   EXPERT OPINION ON EMERGING DRUGS

Validation of the manufacturing process used to produce long-acting recombinant factor IX Fc fusion protein

(2014) J. McCue et al.   HAEMOPHILIA

The effect of palmitoylation on the conformation and physical stability of a model peptide hormone

(2014) Edoardo Longo et al.   INTERNATIONAL JOURNAL OF PHARMACEUTICS

Evaluation of a multimodal resin for selective capture of CHO-derived monoclonal antibodies directly from harvested cell culture fluid

(2014) Kimberly A. Kaleas et al.   JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Process for protein PEGylation

(2014) David Pfister et al.   JOURNAL OF CONTROLLED RELEASE

Synthesis and evaluation of novel lipidated neuromedin U analogs with increased stability and effects on food intake

(2014) Louise S. Dalbøge et al.   JOURNAL OF PEPTIDE SCIENCE

Therapeutic Protein–Polymer Conjugates: Advancing Beyond PEGylation

(2014) Emma M. Pelegri-O’Day et al.   JOURNAL OF THE AMERICAN CHEMICAL SOCIETY

Chemical grafting of Sepharose 6B and its use in the purification of PEGylated RNase A

(2014) Agustín Hernández-Martínez et al.   SEPARATION AND PURIFICATION TECHNOLOGY

Recombinant Human Factor IX Produced from Transgenic Porcine Milk

(2014) Meng-Hwan Lee et al.   Biomed Research International

Albumin as a versatile platform for drug half-life extension

(2013) Darrell Sleep et al.   BIOCHIMICA ET BIOPHYSICA ACTA-GENERAL SUBJECTS

Recent advances in bioprocessing application of membrane chromatography

(2013) Valerie Orr et al.   BIOTECHNOLOGY ADVANCES

A novel B-domain O-glycoPEGylated FVIII (N8-GP) demonstrates full efficacy and prolonged effect in hemophilic mice models

(2013) H. R. Stennicke et al.   BLOOD

Fc-fusion proteins and FcRn: structural insights for longer-lasting and more effective therapeutics

(2013) Timo Rath et al.   CRITICAL REVIEWS IN BIOTECHNOLOGY

Covalent lipid modifications of proteins

(2013) Marilyn D. Resh   CURRENT BIOLOGY

Adsorption of polyethylene-glycolated bovine serum albumin on macroporous and polymer-grafted anion exchangers

(2013) Mimi Zhu et al.   JOURNAL OF CHROMATOGRAPHY A

Cation exchange versus multimodal cation exchange resins for antibody capture from CHO supernatants: Identification of contaminating Host Cell Proteins by mass spectrometry

(2013) G. Joucla et al.   JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

The sweet tooth of biopharmaceuticals: Importance of recombinant protein glycosylation analysis

(2012) Nico Lingg et al.   Biotechnology Journal

Prolonged activity of a recombinant factor VIII-Fc fusion protein in hemophilia A mice and dogs

(2012) J. A. Dumont et al.   BLOOD

Safety and pharmacokinetics of a novel recombinant fusion protein linking coagulation factor IX with albumin (rIX-FP) in hemophilia B patients

(2012) E. Santagostino et al.   BLOOD

Fc-fusion proteins: new developments and future perspectives

(2012) Daniel M. Czajkowsky et al.   EMBO Molecular Medicine

Hydrophobic interaction chromatography for purification of monoPEGylated RNase A

(2012) Karla Mayolo-Deloisa et al.   JOURNAL OF CHROMATOGRAPHY A

The need for innovation in biomanufacturing

(2012) Uwe Gottschalk et al.   NATURE BIOTECHNOLOGY

Design of the Novel Protraction Mechanism of Insulin Degludec, an Ultra-long-Acting Basal Insulin

(2012) Ib Jonassen et al.   PHARMACEUTICAL RESEARCH

The Impact of Glycosylation on the Pharmacokinetics of a TNFR2:Fc Fusion Protein Expressed in Glycoengineered Pichia Pastoris

(2012) Liming Liu et al.   PHARMACEUTICAL RESEARCH

Insulin degludec as an ultralong-acting basal insulin once a day: a systematic review

(2012) Fei Wang et al.   Diabetes Metabolic Syndrome and Obesity-Targets and Therapy

Functional gigaporous polystyrene microspheres facilitating separation of poly(ethylene glycol)–protein conjugate

(2011) Yanqin Zhai et al.   ANALYTICA CHIMICA ACTA

Antibody capture by mixed-mode chromatography: A comprehensive study from determination of optimal purification conditions to identification of contaminating host cell proteins

(2011) Jerome Pezzini et al.   JOURNAL OF CHROMATOGRAPHY A

Technology trends in antibody purification

(2011) Pete Gagnon   JOURNAL OF CHROMATOGRAPHY A

Designing new monoclonal antibody purification processes using mixed-mode chromatography sorbents

(2011) Magali Toueille et al.   JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES

Development of a GMP Phase III purification process for VB4-845, an immunotoxin expressed in E. coli using high cell density fermentation

(2011) Arjune Premsukh et al.   PROTEIN EXPRESSION AND PURIFICATION

Glycosylation of Therapeutic Proteins

(2010) Ricardo J. Solá et al.   BIODRUGS

Increasing parvovirus filter throughput of monoclonal antibodies using ion exchange membrane adsorptive pre-filtration

(2010) Arick Brown et al.   BIOTECHNOLOGY AND BIOENGINEERING

PEGylation of therapeutic proteins

(2010) Simona Jevševar et al.   Biotechnology Journal

Prolonged activity of factor IX as a monomeric Fc fusion protein

(2010) R. T. Peters et al.   BLOOD

Rational design of a fully active, long-acting PEGylated factor VIII for hemophilia A treatment

(2010) B. Mei et al.   BLOOD

Engineering and characterization of the long-acting glucagon-like peptide-1 analogue LY2189265, an Fc fusion protein

(2010) Wolfgang Glaesner et al.   DIABETES-METABOLISM RESEARCH AND REVIEWS

Characterization of the Ligand Binding Functionality of the Extracellular Domain of Activin Receptor Type IIB

(2010) Dianne Sako et al.   JOURNAL OF BIOLOGICAL CHEMISTRY

Delivery of Therapeutic Proteins

(2010) Dipak S. Pisal et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Recovery and purification process development for monoclonal antibody production

(2010) Hui F. Liu et al.   mAbs

Recent advances in large-scale production of monoclonal antibodies and related proteins

(2010) Abhinav A. Shukla et al.   TRENDS IN BIOTECHNOLOGY

Fc-Based Cytokines

(2009) Jalal A Jazayeri et al.   BIODRUGS

Disaggregation of high-molecular weight species during downstream processing to recover functional monomer

(2009) Xuankuo Xu et al.   BIOTECHNOLOGY PROGRESS

A mechanistic study of Protein A chromatography resin lifetime

(2009) Canping Jiang et al.   JOURNAL OF CHROMATOGRAPHY A

Monoclonal antibody purification with hydroxyapatite

(2009) Pete Gagnon   New Biotechnology

Genetic fusion to albumin improves the pharmacokinetic properties of factor IX

(2009) Hubert J. Metzner et al.   THROMBOSIS AND HAEMOSTASIS

The carboxylation efficiency of the vitamin K-dependent clotting factors: studies with factor IX

(2008) M. BLOSTEIN et al.   HAEMOPHILIA

Protein separations with induced pH gradients using cation-exchange chromatographic columns containing weak acid groups

(2008) Timothy M. Pabst et al.   JOURNAL OF CHROMATOGRAPHY A

Polymethacrylate monoliths for preparative and industrial separation of biomolecular assemblies

(2008) Alois Jungbauer et al.   JOURNAL OF CHROMATOGRAPHY A

Lipidization of human interferon-alpha: A new approach toward improving the delivery of protein drugs

(2008) Liyun Yuan et al.   JOURNAL OF CONTROLLED RELEASE

Albumin as a drug carrier: Design of prodrugs, drug conjugates and nanoparticles

(2008) Felix Kratz   JOURNAL OF CONTROLLED RELEASE

An Effective Way To Hydrophilize Gigaporous Polystyrene Microspheres as Rapid Chromatographic Separation Media for Proteins

(2008) Jian-Bo Qu et al.   LANGMUIR

Separation of PEGylated from unmodified ribonuclease A using sepharose media

(2008) Mayra Cisneros-Ruiz et al.   SEPARATION AND PURIFICATION TECHNOLOGY

Generation and biochemical characterization of glycoPEGylated factor VIIa derivatives

(2008) Henrik Østergaard et al.   THROMBOSIS AND HAEMOSTASIS

Selection of pH-related parameters in ion-exchange chromatography using pH-gradient operations

(2007) Tangir Ahamed et al.   JOURNAL OF CHROMATOGRAPHY A