International Journal of Advances in Medical Biotechnology - IJAMB

The importance of the fourth dimensions of fundamental rights in biotechnology and its constitutional effectiveness

Alexandre Eli Alves, Ricardo Augusto Bonotto Barboza — Fri, 01 Mar 2024 00:00:00 -0300

This article analyzes the classification of biotechnology as part of the fourth dimension of fundamental rights, focusing on its essential content and effectiveness as a constitutional norm. The study explores how biotechnology is incorporated into international treaties and how this recognition impacts the enforcement of fundamental rights. A bibliographic and literature review was conducted, drawing on studies, scientific articles, and doctrines from respected researchers and specialists in the fields of biotechnology and fundamental rights. Sources were selected based on their relevance and contemporaneity, focusing on materials from the last ten years. The research examined key international treaties, such as the Convention on Biological Diversity, to assess their role in shaping biotechnology as a fundamental right. The findings reveal significant gaps in Brazilian legislation concerning biotechnology, which hinder the effective implementation of related fundamental rights, particularly in terms of equitable access and sustainable development. While international efforts to regulate biotechnology are advancing, national implementation remains inadequate. The study highlights the need for a more comprehensive normative framework and the development of public policies that ensure the responsible and safe advancement of biotechnology. It concludes that clearer legal interpretation and stronger policy measures are required to fully integrate biotechnology into the fourth dimension of fundamental rights, thereby promoting scientific and technological progress that benefits society effectively and safely.

The pharmaceutical patent process: National Health Surveillance Agency and National Institute of Industrial Property act differently in the process

Leiraud Hilkner De Souza, Creusa Sayuri Tahara Amaral — Fri, 01 Mar 2024 00:00:00 -0300

The National Institute of Industrial Property (INPI) is the government body responsible for granting patents in the national territory; in the case of medicines, they need to be registered with the National Health Surveillance Agency (ANVISA) in order to be marketed. There was a divergence in legal interpretation (of Art. 229-C of the IPL) which caused damage to entrepreneurs, laboratories and the community in general, as there was no express provision as to whether ANVISA's opinion would be binding on the INPI's decision on patent issues. The aim of this research was to analyze this problem, raising its main points and demonstrating how dangerous and damaging bureaucracy and inefficient and obscure normative acts that give rise to dubious interpretation can be, based on the application of hermeneutic and dialectical methods. In 2021, the Superior Court of Justice (STJ), in Special Appeal n. 1543826, held that ANVISA's opinion would be a valid prerequisite for granting patents for pharmaceutical products or processes. It was found that the STJ decision increased ANVISA's "powers", but with the repeal of Art. 229-C of the IPL, the dilemma was extinguished and the competencies of each body re-established. It is therefore of the utmost importance to fill legal gaps and issue clear and specific laws so as not to leave room for harmful interpretations, guaranteeing original competences and legal certainty.

Synthesis, characterization and antibacterial evaluation of cotton fiber coated with chitosan-agar/tannin derivative/polypyrrole composites

Fri, 01 Mar 2024 00:00:00 -0300

The wearable technology and the use of fibers-based devices in biomedical applications are favored by the chemical modification of textiles to incorporate antibacterial properties into the intrinsic mechanical characteristics of the fibers favoring critical applications such as active components for sutures. Herein, it is proposed the combined coating of chitosan and a tannin-derivative (Tanfloc) for the following polymerization of polypyrrole in which the previous deposition of protective layers of chitosan and Tanfloc prevents the degradation in the mechanical properties of coated fiber while incorporates the outstanding performance of polypyrrole as antibacterial and antibiofilm agent reaching a complete elimination of Staphylococcus aureus after 60 min of contact and a reduction in the biofilm formation in order of 99.38%.

Managing Knowledge for Pharma and Biotech Innovation

Fri, 01 Mar 2024 00:00:00 -0300

Knowledge Management (KM) involves a deliberate and systematic organization of people, processes, structure, and technology with the main objective of creating value for innovation from the reuse of data and information. Although there are several models for KM in various types of organizations, there is nothing concrete to integrate the knowledge generated in collaborative University-Industry projects. This work aimed to gather elements for the creation of a sustainable model of effective articulation in this scenario. It is a strategic action that can bring benefits of intellectual, economic, and social impact. This research used different instruments: systematic mapping, questionnaires, and experience reports. The mapping highlighted the need to consider the following aspects for the development of KM models: collaborative/competitive arrangements, tacit/explicit knowledge managers and change screening. The questionnaire and report demonstrated that the challenges go beyond aspects such as data organization. They must prioritize the social aspect of knowledge sharing, using safe coordination to prevent misconduct.

Endocrine activities modulated by adipose-mesenchymal stem cell in an animal model induced to polycystic ovary syndrome

Wed, 10 Jan 2024 00:00:00 -0200

Purpose - Animal models offer a useful way to study the reproductive and metabolic abnormalities, including PCOS. MSCs have received increasing attention as a potential cell-based therapy and regenerative medicine, due to their effects in modulation of different molecular and biological pathways. The aims of the present work were to investigate modulation of the ovarian microenvironment by AdMSCs in an animal model induced to PCOS. Methods - Female rats were divided into control, polycystic ovary, and mesenchymal stem cell groups, evaluated at two different times after PCOS induction and injection of AdMSCs. Results - The polycystic ovary group showed changes in ovarian cycles, the presence of cysts in the ovaries, and hyperandrogenemia. In addition, changes in plasma insulin, glucose, leptin, and osteocalcin were observed in the polycystic ovary group. These metabolic changes were modulated by the injection of AdMSCs into the ovary. Data are presented for female rats in an animal model integrating PCOS with AdMSCs, together with the relationships among ovaries, bones, and adipocytes. Conclusion - The results suggested the existence of endocrine-metabolic-reproductive microenvironment relationships modulated by AdMSCs, which should help in guiding further investigations to clarify pathophysiological mechanisms that have not yet been fully elucidated.

Induction of mineralized matrix production by recombinant human BMP-2 Immobilized in TEMPO-Oxidized Cellulose Hydrogel: a novel target for tissue repair

Fri, 01 Mar 2024 00:00:00 -0300

Bone morphogenetic proteins (BMPs) are potent promoters of osteogenesis, especially BMP-2, which has been highlighted for acting as a growth and differentiation factor that promotes new bone formation. There are several biomaterials that can be used to release bioactive substances, such as natural polymers. Cellulose has stood out for the possibility of its chemical modification using the reagent 2,2,6,6-tetramethyl-1-piperidinyloxy (TEMPO) to obtain a cellulose derivative (TEMPO oxidized cellulose nanofibers - ToCNF), which is shown to be a promising material for biological application. The objective of this work was to evaluate TEMPO cellulose immobilized with rhBMP-2 against the activity of inducing bone cell proliferation and differentiation in vitro, evaluating the ability to form bone matrix in pre-osteoblastic cell lineage of rats - MC3T3. Cell viability assays using resazurin were performed and for detection of mineralized matrix, Alizarin Red solution was used. The results reveal the good capacity of TEMPO cellulose functionalized with rhBM-2 in inducing the synthesis of mineralized bone matrix.