Therapeutic Fc‐fusion proteins: current analytical strategies

BL Duivelshof, A Murisier, J Camperi… - Journal of separation …, 2021 - Wiley Online Library
Fc‐Fusion proteins represent a successful class of biopharmaceutical products, with already
13 drugs approved in the European Union and United States as well as three biosimilar …

Analytical similarity assessment of biosimilars: global regulatory landscape, recent studies and major advancements in orthogonal platforms

N Nupur, S Joshi, D Gulliarme… - … in Bioengineering and …, 2022 - frontiersin.org
Biopharmaceuticals are one of the fastest-growing sectors in the biotechnology industry.
Within the umbrella of biopharmaceuticals, the biosimilar segment is expanding with …

Development of mAb-loaded 3D-printed (FDM) implantable devices based on PLGA

E Carlier, S Marquette, C Peerboom, K Amighi… - International journal of …, 2021 - Elsevier
The main objective of this work was to explore the feasibility to print monoclonal antibody
(mAb)-loaded implantable systems using fused-deposition modelling (FDM) to build …

Comprehensive physicochemical and functional analysis of pembrolizumab based on controlled degradation studies: Impact on antigen–antibody binding

A Torrente-López, J Hermosilla… - European Journal of …, 2024 - Elsevier
Monoclonal antibodies-based medicines are widely used in the treatment of different
diseases. These medicines are very sensitive to exposure to different environmental …

Comprehensive analysis of nivolumab, a therapeutic anti-Pd-1 monoclonal antibody: impact of handling and stress

A Torrente-López, J Hermosilla, A Salmerón-García… - Pharmaceutics, 2022 - mdpi.com
Nivolumab, formulated in the medicine Opdivo®(10 mg/mL), is a therapeutic monoclonal
antibody (mAb) used in the treatment of different types of cancer. Currently, there is …

[HTML][HTML] Comprehensive physicochemical characterization of a peptide-based medicine: Teduglutide (Revestive®) structural description and stress testing

R Pérez-Robles, A Salmerón-García… - European Journal of …, 2023 - Elsevier
Teduglutide (Revestive®) is a glucagon-like peptide-2 analogue used for the treatment of
short bowel syndrome, a rare life-threatening condition in which the amount of functional gut …

[HTML][HTML] Comprehensive Analysis of Cetuximab Critical Quality Attributes: Impact of Handling on Antigen-Antibody Binding

A Torres-García, A Torrente-López, J Hermosilla… - Pharmaceutics, 2024 - mdpi.com
Background/Objectives: Cetuximab, formulated in Erbitux®(5 mg/mL), is a therapeutic
monoclonal antibody (mAb) widely used in several cancer treatments. Currently, there is …

[HTML][HTML] Use of subcutaneous tocilizumab to prepare intravenous solutions for COVID-19 emergency shortage: Comparative analytical study of physicochemical …

N Navas, J Hermosilla, A Torrente-López… - Journal of …, 2020 - Elsevier
COVID-19, a disease caused by the novel coronavirus SARS-CoV-2, has produced a
serious emergency for global public health, placing enormous stress on national health …

The Development of a Novel Aflibercept Formulation for Ocular Delivery

JA Floyd, AJ Gillespie, NS Nightlinger, C Siska… - Journal of …, 2024 - Elsevier
Aflibercept is a recombinant fusion protein that is commercially available for several ocular
diseases impacting millions of people worldwide. Here, we use a case study approach to …

Effectiveness of the use of three-dose Intravitreal Ziv-Aflibercept in the Management of Diabetic Macular Edema in a Real-Life Setting

F Munayco-Guillén, MA Vazquez-Membrillo… - Clinical …, 2023 - Taylor & Francis
Purpose It has been reported that intravitreal Ziv-aflibercept is a safe and effective drug for
the treatment of diabetes macular edema (DME). The objective of this study was to evaluate …