Pronalyse is a new division of Creative Proteomics, which is an integrated CRO company with rich experience in providing drug development services. Building on its years of experience, Creative Proteomics Pronalyse announces the launch of its metabolite identification services of biopharmaceuticals for an accurate and efficient analysis of the metabolism for your biological drugs in vivo.

The application of LC-MS/MS in biotechnological drug metabolite identification is a popular research topic. Meanwhile, high resolution mass spectrometry (HRMS) has gained increasing attention in recent years as a complete protein quantification strategy due to its ability to directly determine the content of protein drugs and metabolites.

Traditional bottom-up quantification strategies for monoclonal antibodies and macromolecular protein drugs require the use of multiple reaction assay (MRM) scanning modes to identify the target protease after cleavage. Now, a complete HRMS-based protein quantification scheme, also known as a top-down quantification strategy, offers an innovative, high-throughput and simpler method to directly determine post-translational modifications of monoclonal antibodies and related proteins.

With high-resolution mass spectrometers, advanced analytical software and extensive project experience, Creative Proteomics provides the following accurate and efficient analysis of the metabolism of your biological drugs in vivo.

Metabolite Identification of Protein/Peptide Drugs

Protein/peptide drugs may undergo non-specific digestion after intravenous injection into the bloodstream or into cells. After digestion, the amino acid sequence may undergo further amino acid modifications and be metabolized by hepatic P450 enzymes. In vivo metabolite studies of protein/peptide drugs usually focus on non-specific enzymatic cleavage or modification of amino acids, P450 enzyme metabolism, and multi-charge distribution.

Metabolite identification of ADC

During ADC metabolism, cleavage of the junction produces a large antibody fraction, a free junction, and a small molecule drug fraction; while enzymatic cleavage of the antibody produces a small molecule drug linked by a linker and a small amount of amino acid residues. Since the metabolism of small molecules is directly related to the toxicity of drugs, both free junction and small molecule drug and junction and small molecule drug with a small number of amino acid residues have become hot topics for metabolite research.

Metabolite identification of monoclonal antibodies

While in vivo modifications of monoclonal antibodies have been reported, such as oxidation, deamidation, glutamate/pyroglutamate conversion and carboxy-terminal lysine shearing, in vivo metabolite studies of monoclonal antibodies focus on the type and site of amino acid modifications.

“Scientists at Creative Proteomics have expertise and experience in metabolite analysis and PK analysis of biopharmaceutical products. We offer services in different aspects including metabolite isolation, metabolite identification, as well as immunological assays and bioassays for PK analysis. In addition, we can provide customized services in the pharmacokinetics of biopharmaceutical products.” commented the Pronalyse’s project manager.

About Pronalyse of Creative Proteomics

Pronalyse is supported by specialists who are professional and skilled in protein chemistry, NMR, HPLC, mass spectrometry and bioinformatics. Currently, Pronalyse is dedicated to providing protein-oriented analysis services to support manufacturers and researchers in biopharmaceutical development, mainly including antibodies, PEGylated proteins, peptide and protein drugs, vaccines, amino acids and their derivatives. The services provided include in vitro characterization, purity analysis, protein structure modification, in vivo safety checks, and pharmacokinetics analysis, etc.

Contact:

Address: Shirley, NY 11967, USA

Email: contact@creative-proteomics.com