Advertisement

Topics

Assessment of the higher order structure of Humira®, Remicade®, Avastin®, Rituxan®, Herceptin®, and Enbrel® by 2D-NMR fingerprinting.

08:00 EDT 1st October 2018 | BioPortfolio

Summary of "Assessment of the higher order structure of Humira®, Remicade®, Avastin®, Rituxan®, Herceptin®, and Enbrel® by 2D-NMR fingerprinting."

The advent of monoclonal antibody biosimilar products has stimulated the development of analytical methods that can better characterize an important quality attribute, namely the higher order structure (HOS). Here, we propose a simple approach based on heteronuclear 2D NMR techniques at natural abundance for generating spectral fingerprints of the HOS at high resolution. We show that the proposed method can assess the HOS of six therapeutic products, adalimumab (Humira®), bevacizumab (Avastin®), infliximab (Remicade®), rituximab (Rituxan®), trastuzumab (Herceptin®), and Etanercept (Enbrel®). After treatment with immobilized papain, the purified fragments (Fab and Fc) were analyzed by 2D proton-nitrogen and proton-carbon NMR correlations. All Fab and Fc fragments produced high-resolution 2D-NMR spectra from which assessment of their higher order structure can be performed in the context of comparability studies. In particular, the two different sequences of Fc fragments could be unambiguously distinguished. The results show that it is possible to obtain structurally dependent information at amino acid resolution of these important therapeutic agents.

Affiliation

Journal Details

This article was published in the following journal.

Name: Journal of pharmaceutical and biomedical analysis
ISSN: 1873-264X
Pages: 144-152

Links

DeepDyve research library

PubMed Articles [22291 Associated PubMed Articles listed on BioPortfolio]

Evaluation of similar quality attribute characteristics in SB5 and reference product of adalimumab.

Biosimilars are biologic products that are highly similar to a licensed reference product in terms of quality, safety, and efficacy. SB5 is a biosimilar of Humira® (adalimumab) developed by Samsung B...

A reassessment of the higher-order factor structure of the German Schizotypal Personality Questionnaire (SPQ-G) in German-speaking adults.

The Schizotypal Personality Questionnaire (SPQ) is a widely-used self-report instrument for the assessment of schizotypal personality traits. However, the factor structure of scores on English and non...

Simplicial closure and higher-order link prediction.

Networks provide a powerful formalism for modeling complex systems by using a model of pairwise interactions. But much of the structure within these systems involves interactions that take place among...

Prediction of TF-binding site by inclusion of higher order position dependencies.

Most proposed methods for TF-binding site (TFBS) predictions only use low order dependencies for predictions due to the lack of efficient methods to extract higher order dependencies. In this work, We...

Rational Higher-Order Belief Revision in Young Children.

Belief revision can occur at multiple levels of abstraction, including lower-level and higher-order beliefs. It remains unclear, however, how conflicting evidence interacts with prior beliefs to encou...

Clinical Trials [6842 Associated Clinical Trials listed on BioPortfolio]

Study of Higher Dose of Rituxan Versus Standard Doses of Rituxan With Cyclophosphamide, Vincristine, and Prednisone in Subjects With Chronic ITP

This study is designed to compare the efficacy and safety of higher doses of Rituxan with a regimen combining standard doses of Rituxan + CVP in patients with chronic ITP who did not respo...

Surveillance of Humira Injection in Korean Patients

Patients who take Humira as prescribed by physicians as per Korean label will be enrolled and observed in normal medical practice setting for not less than 3 months following first dose of...

CMAB008 With MTX Therapy in Adult Patients With Moderately to Severely Active Rheumatoid Arthritis

CMAB008 is an infliximab biosimilar candidate. The host cell of Remicade is mouse myeloma SP2/0 cell, however, the host cell of CMAB008 is CHO (Chinese hamster ovary cell). It seems that C...

Adalimumab PK Bioequivalence Study to EU and US Sourced Humira

Double-Blind, 3-Way Parallel Study to Compare the Pharmacokinetics, Safety and Tolerability of BMO-2 to EU and US Sourced Humira® Administered as a Single Dose (40 mg) Subcutaneous Inject...

Humira in Rheumatoid Arthritis - Do Bone Erosions Heal?

Studies on tumor necrosis factor alpha antagonist (anti-TNF) therapy in rheumatoid arthritis (RA) patients have found that erosive damage may "heal" in some RA patients treated with anti-T...

Medical and Biotech [MESH] Definitions

Evaluation and measurement of nutritional variables in order to assess the level of nutrition or the NUTRITIONAL STATUS of the individual. NUTRITION SURVEYS may be used in making the assessment.

Systematic identification of a population's needs or the assessment of individuals to determine the proper level of services needed.

Evaluation procedures that focus on both the outcome or status (OUTCOMES ASSESSMENT) of the patient at the end of an episode of care - presence of symptoms, level of activity, and mortality; and the process (ASSESSMENT, PROCESS) - what is done for the patient diagnostically and therapeutically.

BIRDS that hunt and kill other animals, especially higher vertebrates, for food. They include the FALCONIFORMES order, or diurnal birds of prey, comprised of EAGLES, falcons, HAWKS, and others, as well as the STRIGIFORMES order, or nocturnal birds of prey, which includes OWLS.

The primordial kidney that develops from the INTERMEDIATE MESODERM in the embryos of vertebrates, and is succeeded by the MESONEPHROS. In higher vertebrates and humans, the pronephros is a vestigial and transient structure.

Advertisement
Quick Search
Advertisement
Advertisement

 


DeepDyve research library

Relevant Topic

Antibodies
An antibody is a protein produced by the body's immune system when it detects harmful substances, called antigens. Examples of antigens include microorganisms (such as bacteria, fungi, parasites, and viruses) and chemicals. Antibodies may be produc...


Searches Linking to this Article