Platform for a precision mass measurement in sequencing of therapeutic proteins (PREMISE)

Anno
2018
Proponente Alberto Boffi - Professore Ordinario
Sottosettore ERC del proponente del progetto
Componenti gruppo di ricerca
Abstract

The project concerns the establishment the first platform in Sapienza with the capability to meet modern-day challenges in therapeutic protein production, for both the Research and Development (R&D) cycle and Quality Control (QC) process. With the ambitious goal to create a multidisciplinary network for biotechnological applications, the project is centered on the acquisition of equipment combining precise mass measurements of proteins, high-throughput of analyses, user-friendly sample preparation, and researchers self-using. MALDI-ToF/ToF is the preferred solution, being the indispensable technique for a large number of purposes in biomolecules analyses.
Among several applications, the most challenging commitment for PREMISE is the physical chemical characterization of biosimilars from plants. The development pathway of a biosimilar is somewhat different from a novel biotherapeutic with a greatly increased requirement for physicochemical analytics compared to a novel biological molecule. The recently revised EMA quality guideline provides some additional clarification about analytical strategies. State-of-the-art analytical methods must be used to assess composition, physical properties, primary and higher order structure, purity, product-related substances and impurities to be compared between the biosimilar and the originator. Advances in MALDI instrumentation and proteomics/glycomics strategies enable rapid identification of structural data such as monosaccharide composition, glycan populations, antennary profiles, antennae linkages and glycosylation sites.
Within PREMISE these issues will addressed settled on competence from three Sapienza Departments. Interaction with internal and external academic groups and with non-academic components will be implemented to offer a cutting-edge tool for a precise and fast structural screening of molecules in different areas of basic and translational research.

ERC
LS1_2, LS2_9, LS2_10
Keywords:
PROCESSI E PRODOTTI BIOTECNOLOGICI, SCOPERTA E DESIGN DI FARMACI, PROTEINE RICOMBINANTI, PROTEOMICA, BIOTECNOLOGIE FARMACEUTICHE

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