Creative Proteomics Offers ADC Characterization as a Service (CaaS) under Pronalyse

Characterization as a Service (CaaS)

A new division of Creative Proteomics, Pronalyse is an integrated contract research organization (CRO) with over ten years of experience in the drug development industry. Antibody-drug conjugates (ADCs) characterization service has recently been introduced by Creative Proteomics Pronalyse to guarantee the security and efficiency of ADCs medications.

The Dawn of ADC R&D

Globally, research and development of antibody-drug conjugates (ADCs) have increased recently.

ADCs are brand-new therapeutic biotechnology medications that combine monoclonal antibodies with potent cytotoxic small molecules through biologically active linkers. They are powerful anticancer medications that specifically target cancer cells and are anticipated to have a significant contribution to the treatment of disease in the future.

ADC Pharmacodynamics

ADC presents significant difficulties in structural characterization and characteristic analysis compared to monoclonal antibodies due to its complicated structure and high degree of heterogeneity. The examination of the poison-conjugation site, the measurement of the poison-antibody coupling ratio (DAR, drug:antibody ratio), and the coupling ratio of the site are among the most challenging and complicated. You can overcome these difficulties with the aid of the bioinformatics platform from Creative Proteomics Pronalyse.

Through the use of monoclonal antibodies to target cancer cells selectively, small molecule medicines are then used to kill those cancer cells. ADCs combine the high efficiency of small molecule medications with the great specificity and targeting of monoclonal antibody therapeutics to eradicate cancer cells. It can minimize harm to biological systems by combining the benefits of chemical and antibody medicines.

The Rationale Behind Characterization

The efficacy and safety of ADC medications may be impacted by heterogeneity of conjugated medicines, cytotoxic small compounds, and unconjugated naked antibodies. Therefore, in-depth characterization and quality monitoring of ADCs are necessary to acquire permission for clinical trials and subsequent marketing in order to ensure the safety and efficacy of ADCs.

The relevant technical guidelines (EP) of the International Conference on Harmonization of Registered Drugs for Human Use (ICH), the United States Food and Drug Administration (FDA), the United States Pharmacopoeia (USP), and the European Pharmacopoeia are primarily referred to in the quality standards for testing.

The Creative Proteomics Arsenal

High-performance liquid chromatography (HPLC), high-throughput mass spectrometry, and bioinformatics systems are all state-of-the-art at Creative Proteomics. To determine the intact mass, deglycosylated mass, drug/antibody ratio, and polysaccharide composition of antibody-drug conjugates, Creative Proteomics Pronalyse created a comprehensive set of methodologies. While doing so, Creative Proteomics Pronalyse will closely adhere to a number of quality criteria and offer you unique solutions.

About Pronalyse Division of Creative Proteomics

Specialists in protein chemistry, NMR, HPLC, mass spectrometry, and bioinformatics are employed by Pronalyse as support staff. Pronalyse’s current focus is on offering protein-focused analytical services to assist producers and researchers in the development of biopharmaceuticals, including antibodies, PEGylated proteins, peptide and protein medicines, vaccines, amino acids, and their derivatives. In vivo safety testing, protein structural modification, purity analysis, in vitro characterization, pharmacokinetics analysis, and other services are offered.

Scientists from Creative Proteomics are glad to discuss with you the details of your project and develop tailored experimental strategies. Let Creative Proteomics Pronalyse’s strong scientific and technical expertise guide your biopharmaceutical development programs to success. Learn more about Pronalyse via following this link https://www.creative-proteomics.com/pronalyse/.

Engr. Dex Marco Tiu Guibelondo, BS Pharm, RPh, BS CpE

Editor-in-Chief, PharmaFEATURES