4.5 Review

The Evolution of Commercial Antibody Formulations

Related references

Note: Only part of the references are listed.
Review Medicine, Research & Experimental

Blueprint for antibody biologics developability

Carl Mieczkowski et al.

Summary: Large-molecule antibody biologics have greatly advanced medicine by offering superior target specificity, pharmacokinetic and pharmacodynamic properties, safety profiles, and engineering possibilities. This review focuses on preclinical antibody developability, including activities from hit to lead optimization and selection. It explores emerging workflows and strategies for developability success, and examines risk assessment and mitigation strategies for successful clinical progression.
Article Chemistry, Medicinal

Ongoing Challenges to Develop High Concentration Monoclonal Antibody-based Formulations for Subcutaneous Administration: Quo Vadis

W. Jiskoot et al.

Summary: Although many subcutaneously delivered, high-concentration antibody formulations have been approved and widely used, formulation scientists still face challenges in developing new monoclonal antibody-based drugs. These challenges include pharmaceutical attributes, clinical performance, and patient experience. This commentary focuses on the obstacle of maximizing the dose of the drug during HCAF development.

JOURNAL OF PHARMACEUTICAL SCIENCES (2022)

Review Chemistry, Multidisciplinary

Non-specificity as the sticky problem in therapeutic antibody development

Hannes Ausserwoger et al.

Summary: This article reviews the physicochemical origins of non-specific interactions in antibodies and discusses the role of surface patches in inducing these interactions. These non-specific interactions have an impact on macroscopic development issues such as the physical stability and in vivo half-life of drugs. The article highlights the challenges and opportunities for optimizing protein binding specificity and minimizing non-specificity.

NATURE REVIEWS CHEMISTRY (2022)

Review Pharmacology & Pharmacy

Machine Learning for Biologics: Opportunities for Protein Engineering, Developability, and Formulation

Harini Narayanan et al.

Summary: Successful biologics must meet requirements of both activity and physicochemical features, which can be optimized with the help of artificial intelligence and machine learning to reduce development time and costs. Machine learning is currently applied in biologics discovery and development, particularly in areas such as protein engineering, early biophysical screening, and formulation.

TRENDS IN PHARMACOLOGICAL SCIENCES (2021)

Review Chemistry, Medicinal

A review of formulations of commercially available antibodies

Robert G. Strickley et al.

Summary: This review examines 126 commercially available antibodies approved globally between 1986 and February 2021, including various formulations, routes of administration, and formulation components. The number of approved antibodies per year has increased significantly after 2014. Most antibody products are packaged in single-dose units, with different routes of administration and formulation components.

JOURNAL OF PHARMACEUTICAL SCIENCES (2021)

Article Chemistry, Medicinal

Caffeine as a Viscosity Reducer for Highly Concentrated Monoclonal Antibody Solutions

Yuhong Zeng et al.

Summary: The study demonstrates that caffeine can effectively reduce the viscosity of mAb formulations, while commonly used viscosity-reducing excipients like sodium chloride and arginine may not achieve the same effect. Furthermore, caffeine does not affect the stability or in vitro bioactivities of the formulations.

JOURNAL OF PHARMACEUTICAL SCIENCES (2021)

Article Multidisciplinary Sciences

Highly accurate protein structure prediction with AlphaFold

John Jumper et al.

Summary: Proteins are essential for life, and accurate prediction of their structures is a crucial research problem. Current experimental methods are time-consuming, highlighting the need for accurate computational approaches to address the gap in structural coverage. Despite recent progress, existing methods fall short of atomic accuracy in protein structure prediction.

NATURE (2021)

Review Chemistry, Medicinal

Physicochemical Stability of Monoclonal Antibodies: A Review

Yoann Le Basle et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2020)

Article Chemistry, Medicinal

What Makes Polysorbate Functional? Impact of Polysorbate 80 Grade and Quality on IgG Stability During Mechanical Stress

Adam Dariusz Grabarek et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2020)

Article Chemistry, Medicinal

Engineering Stability, Viscosity, and Immunogenicity of Antibodies by Computational Design

Daisuke Kuroda et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2020)

Review Cell Biology

Development of therapeutic antibodies for the treatment of diseases

Ruei-Min Lu et al.

JOURNAL OF BIOMEDICAL SCIENCE (2020)

Review Medicine, Research & Experimental

Subcutaneous Injection of Drugs: Literature Review of Factors Influencing Pain Sensation at the Injection Site

Iris Usach et al.

ADVANCES IN THERAPY (2019)

Article Chemistry, Medicinal

Edetate Disodium as a Polysorbate Degradation and Monoclonal Antibody Oxidation Stabilizer

Melissa Yarbrough et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2019)

Article Medicine, Research & Experimental

Deamidation and isomerization liability analysis of 131 clinical-stage antibodies

Xiaojun Lu et al.

Review Biotechnology & Applied Microbiology

Understanding and overcoming trade-offs between antibody affinity, specificity, stability and solubility

Lilia A. Rabia et al.

BIOCHEMICAL ENGINEERING JOURNAL (2018)

Review Biochemistry & Molecular Biology

Viscosity Control of Protein Solution by Small Solutes: A Review

Taehun Hong et al.

CURRENT PROTEIN & PEPTIDE SCIENCE (2018)

Article Biochemical Research Methods

Determination of isoelectric points and relative charge variants of 23 therapeutic monoclonal antibodies

Alexandre Goyon et al.

JOURNAL OF CHROMATOGRAPHY B-ANALYTICAL TECHNOLOGIES IN THE BIOMEDICAL AND LIFE SCIENCES (2017)

Article Medicine, Research & Experimental

In-silico prediction of concentration-dependent viscosity curves for monoclonal antibody solutions

Dheeraj S. Tomar et al.

Article Multidisciplinary Sciences

Biophysical properties of the clinical-stage antibody landscape

Tushar Jain et al.

PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA (2017)

Review Chemistry, Medicinal

Monoclonal antibodies: formulations of marketed products and recent advances in novel delivery system

Yanan Cui et al.

DRUG DEVELOPMENT AND INDUSTRIAL PHARMACY (2017)

Article Medicine, Research & Experimental

Computational tool for the early screening of monoclonal antibodies for their viscosities

Neeraj J. Agrawal et al.

Review Chemistry, Medicinal

Developability Assessment During the Selection of Novel Therapeutic Antibodies

Alexander Jarasch et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2015)

Article Medicine, Research & Experimental

Viscosity-Lowering Effect of Amino Acids and Salts on Highly Concentrated Solutions of Two IgG1 Monoclonal Antibodies

Shujing Wang et al.

MOLECULAR PHARMACEUTICS (2015)

Review Biochemical Research Methods

Accelerated Formulation Development of Monoclonal Antibodies (mAbs) and mAb-Based Modalities: Review of Methods and Tools

Vladimir I. Razinkov et al.

JOURNAL OF BIOMOLECULAR SCREENING (2015)

Article Biotechnology & Applied Microbiology

Plasmonic Measurements of Monoclonal Antibody Self-Association Using Self-Interaction Nanoparticle Spectroscopy

Jayapriya Jayaraman et al.

BIOTECHNOLOGY AND BIOENGINEERING (2014)

Article Multidisciplinary Sciences

In silico selection of therapeutic antibodies for development: Viscosity, clearance, and chemical stability

Vikas K. Sharma et al.

PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES OF THE UNITED STATES OF AMERICA (2014)

Editorial Material Pharmacology & Pharmacy

Development of high concentration protein biopharmaceuticals: The use of platform approaches in formulation development

Nicholas W. Warne

EUROPEAN JOURNAL OF PHARMACEUTICS AND BIOPHARMACEUTICS (2011)

Article Biotechnology & Applied Microbiology

Impact of Freezing on pH of Buffered Solutions and Consequences for Monoclonal Antibody Aggregation

Parag Kolhe et al.

BIOTECHNOLOGY PROGRESS (2010)

Review Pharmacology & Pharmacy

Protein aggregation-Pathways and influencing factors

Wei Wang et al.

INTERNATIONAL JOURNAL OF PHARMACEUTICS (2010)

Article Chemistry, Medicinal

Factors Affecting the Viscosity in High Concentration Solutions of Different Monoclonal Antibodies

Sandeep Yadav et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2010)

Article Chemistry, Medicinal

An Industry Perspective on the Monitoring of Subvisible Particles as a Quality Attribute for Protein Therapeutics

Satish K. Singh et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2010)

Review Biochemical Research Methods

Formulation and manufacturability of biologics

Steven J. Shire

CURRENT OPINION IN BIOTECHNOLOGY (2009)

Editorial Material Chemistry, Medicinal

Overlooking Subvisible Particles in Therapeutic Protein Products: Gaps That May Compromise Product Quality

John F. Carpenter et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2009)

Review Chemistry, Medicinal

Antibody structure, instability, and formulation

Wei Wang et al.

JOURNAL OF PHARMACEUTICAL SCIENCES (2007)