Development of freeze-dried albumin nanoparticle kit to lymphoscintigraphy and sentinel lymph node detection

• Grant number: 19/16439-8
• Support type: Research Grants - Innovative Research in Small Business - PIPE
• Duration: August 01, 2020 - April 30, 2021
• Field of knowledge: Engineering - Nuclear Engineering - Applications of Radioisotopes
• Principal researcher: Aryel Heitor Ferreira
• Grantee: Aryel Heitor Ferreira
• Company: Nanoradiopharmaceuticals Pesquisa e Desenvolvimento Ltda
• CNAE: Fabricação de medicamentos para uso humano ; Fabricação de preparações farmacêuticas
• City: São Paulo
• Pesquisadores principais: Ademar Benévolo Lugão
• Assoc. researchers: Caroline Cristiano Real Gregório ; Daniele de Paula Faria ; Fabio Luiz Navarro Marques ; Lucas Freitas de Freitas ; Mara de Souza Junqueira
• Associated scholarship(s): 20/10781-3 - Development of freeze-dried albumin nanoparticle kit to lymphoscintigraphy and sentinel lymph node detection, BP.PIPE

Abstract

Differentiation of "localized" cancer from "metastatic" cancer is widely used to decide whether systemic chemotherapy is required after surgery for many cancer subtypes. Surgical biopsy and histology of the sentinel lymph nodes - draining a primary tumor site-have become the gold standard in differentiating localized from metastatic solid cancers and is being increasingly used in the management in a number of other solid tumor cancer types, including colon, head and neck, penile, gastric, lung, and gynecologic. Imaging techniques in nuclear medicine have become important tools for early carcinomas detection, monitoring disease progression and evaluation of therapeutic responses, it is an attractive strategy to monitor non-invasively the sentinel lymph nodes. Currently, the combination of dye labeling and 99mTc radiocolloids is the technique, associated with pathological analysis (biopsy), with greater acceptance in clinical practice due to the high values of specificity and sensitivity. The aim of this project is to elaborate a business plan, market study, large-scale production, and commercialization of albumin nanoparticles synthesized by an alternative method, based on ionizing radiation-induced crosslinking which has a clinical interest in sentinel lymph nodes detection. In addition to establishing a manufacturing facility, following national and international standards of Good Manufacturing Practice and Drug Control, starting its production on an industrial scale of sterile and freeze-dried kits of albumin nanoparticle. Representing this company an opportunity to development and standardization of freeze-dried kits to be used by the Brazilian nuclear medical community. (AU)