Quantitative analysis of antibody aggregates by combination of pinched-flow fractionation and coulter method

Plate reader-based analytical method for the size distribution of submicron-sized protein aggregates using three-dimensional homodyne light detection

(2021) Ayano Fukuhara et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

An Insight into FDA Approved Antibody-Drug Conjugates for Cancer Therapy

(2021) Juliana T. W. Tong et al.   MOLECULES

Recent Achievements and Current Interests in Research on the Characterization and Quality Control of Biopharmaceuticals in Japan

(2020) Akiko Ishii-Watabe et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Protein aggregation and immunogenicity of biotherapeutics

(2020) Ngoc B. Pham et al.   INTERNATIONAL JOURNAL OF PHARMACEUTICS

Particle Detection and Characterization for Biopharmaceutical Applications: Current Principles of Established and Alternative Techniques

(2020) Julia Gross-Rother et al.   Pharmaceutics

Bispecific antibodies: a mechanistic review of the pipeline

(2019) Aran F. Labrijn et al.   NATURE REVIEWS DRUG DISCOVERY

Physicochemical Stability of Monoclonal Antibodies: A Review

(2019) Yoann Le Basle et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

A Multicompany Assessment of Submicron Particle Levels by NTA and RMM in a Wide Range of Late-phase Clinical and Commercial Biotechnology-Derived Protein Products

(2019) Mario Hubert et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Protein aggregation – Mechanisms, detection, and control

(2018) Wei Wang et al.   INTERNATIONAL JOURNAL OF PHARMACEUTICS

Critical evaluation of microfluidic resistive pulse sensing for quantification and sizing of nanometer- and micrometer-sized particles in biopharmaceutical products

(2018) Adam D. Grabarek et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Quantitative laser diffraction (qLD) for a quantification of protein aggregates – comparison with resonant mass measurement, nano-particle tracking, flow imaging and light obscuration

(2018) Saki Yoneda et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Validation of a particle tracking analysis method for the size determination of nano- and microparticles

(2017) Vikram Kestens et al.   JOURNAL OF NANOPARTICLE RESEARCH

Strategies and challenges for the next generation of antibody–drug conjugates

(2017) Alain Beck et al.   NATURE REVIEWS DRUG DISCOVERY

Quantitative Laser Diffraction Method for the Assessment of Protein Subvisible Particles

(2015) Shinichiro Totoki et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Factors Governing the Precision of Subvisible Particle Measurement Methods – A Case Study with a Low-Concentration Therapeutic Protein Product in a Prefilled Syringe

(2015) Anacelia Ríos Quiroz et al.   PHARMACEUTICAL RESEARCH

Protein aggregation, particle formation, characterization & rheology

(2014) Samiul Amin et al.   CURRENT OPINION IN COLLOID & INTERFACE SCIENCE

Therapeutic protein aggregation: mechanisms, design, and control

(2014) Christopher J. Roberts   TRENDS IN BIOTECHNOLOGY

Guidance for Industry: Immunogenicity Assessment for Therapeutic Protein Products [excerpts]

(2013)   BIOTECHNOLOGY LAW REPORT

Aggregation analysis of pharmaceutical human immunoglobulin preparations using size-exclusion chromatography and analytical ultracentrifugation sedimentation velocity

(2012) Elena Krayukhina et al.   JOURNAL OF BIOSCIENCE AND BIOENGINEERING