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 …

Susceptibility of protein therapeutics to spontaneous chemical modifications by oxidation, cyclization, and elimination reactions

L Grassi, C Cabrele - Amino Acids, 2019 - Springer
Peptides and proteins are preponderantly emerging in the drug market, as shown by the
increasing number of biopharmaceutics already approved or under development …

Proteolytic Profiling of Streptococcal Pyrogenic Exotoxin B (SpeB) by Complementary HPLC-MS Approaches

C Blöchl, C Holzner, M Luciano, R Bauer… - International Journal of …, 2021 - mdpi.com
Streptococcal pyrogenic exotoxin B (SpeB) is a cysteine protease expressed during group A
streptococcal infection that represents a major virulence factor. Although subject to several …

Photo-oxidation of therapeutic protein formulations: from radical formation to analytical techniques

E Hipper, M Blech, D Hinderberger, P Garidel… - Pharmaceutics, 2021 - mdpi.com
UV and ambient light-induced modifications and related degradation of therapeutic proteins
are observed during manufacturing and storage. Therefore, to ensure product quality …

mAbs N-glycosylation: Implications for biotechnology and analytics

T Wang, L Liu, J Voglmeir - Carbohydrate Research, 2022 - Elsevier
Monoclonal antibodies (mAbs) are amazingly successful in treating diseases such as
various types of cancers, immune disorders, and infections. Currently, mAbs are considered …

Development and optimization of a LC-MS based multi-attribute method (MAM) workflow for characterization of therapeutic Fc-fusion protein

A Puranik, P Rasam, P Dandekar, R Jain - Analytical Biochemistry, 2023 - Elsevier
The growing complexity of novel biopharmaceutical formats, such as Fc-fusion proteins, in
increasingly competitive environment has highlighted the need of high-throughput analytical …

Orthogonal middle-up approaches for characterization of the glycan heterogeneity of etanercept by hydrophilic interaction chromatography coupled to high-resolution …

V D'Atri, L Novakova, S Fekete, D Stoll… - Analytical …, 2018 - ACS Publications
Etanercept is a recombinant Fc fusion protein widely used to treat rheumatic diseases. This
protein is highly glycosylated and contains numerous O-and N-glycosylation sites. Since …

[HTML][HTML] A robust nanoscale RP HPLC-MS approach for sensitive Fc proteoform profiling of IgG allotypes

C Blöchl, C Gstöttner, T Sénard, EM Stork… - Analytica Chimica …, 2023 - Elsevier
The conserved region (Fc) of IgG antibodies dictates the interactions with designated
receptors thus defining the immunological effector functions of IgG. Amino acid sequence …

Multi-attribute method based characterization of antibody drug conjugates (ADC) at the intact and subunit levels

A Martelet, V Garrigue, Z Zhang, B Genet… - … of Pharmaceutical and …, 2021 - Elsevier
Antibody–drug conjugates (ADCs) represent an important class of new biopharmaceutical
modalities. ADCs are highly complex and heterogeneous molecules, potentially containing …

Identification and quantification of oxidation products in full-length biotherapeutic antibodies by NMR spectroscopy

A Hinterholzer, V Stanojlovic, C Regl… - Analytical …, 2020 - ACS Publications
Therapeutic proteins are an indispensable class of drugs and often therapeutics of last
resort. They are sensitive to oxidation, which is of critical concern, because it can affect drug …