FCS (DCF) - Capítulos de Livros em Editoras Internacionais
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- Capítulo 6 - MicroencapsulaciónPublication . Lopes, Carla Martins; Barata, Pedro
- Chapter 14: Lipid-based colloidal carriers for topical application of antiviral drugsPublication . Lopes, Carla Martins; Silva, Juliana; Real Oliveira, Maria Elisabete C.D.; Lúcio, Marlene
- Chapter 5: Stimuli-responsive nanosystems for drug-targeted deliveryPublication . Lopes, Carla Martins; Barata, Pedro; Oliveira, Rita
- Cytokines and growth factorsPublication . Silva, Ana Catarina; Lobo, J. M. SousaSeveral cytokines have been used to treat autoimmune diseases, viral infections, and cancer and to regenerate the skin. In particular, interferons (INFs) have been used to treat cancer, hepatitis B and C, and multiple sclerosis, while interleukins (ILs) and tumor necrosis factors (TNFs) have been used in the management of different types of cancer. Concerning the hematopoietic growth factors (HGFs), epoetin has been used for anemia, whereas the colony-stimulating factors (CSFs) have been used for neutropenia. Other growth factors have been extensively explored, although most still need to demonstrate in vivo clinical relevance before reaching the market.This chapter provides an overview on the therapeutic applications of biological medicines containing recombinant cytokines and growth factors (HGFs and others). From this review, we concluded that the clinical relevance of recombinant cytokines has been increasing. Since the 1980s, the European Medicines Agency (EMA) and/or Food and Drug Administration (FDA) have approved 89 biological medicines containing recombinant cytokines. Among these, 18 were withdrawn, 24 are biosimilars, and 18 are orphans.So far, considerable progress has been made in discovering new cytokines, additional cytokine functions, and how they interfere with human diseases. Future prospects include the approval of more biological and biosimilar medicines for different therapeutic applications.
- Hematopoietic growth factorsPublication . Silva, Ana Catarina; Moreira, João Nuno; Lobo, José Manuel Sousa
- Hormones, blood products, and therapeutic enzymesPublication . Silva, Ana Catarina; Costa, Cláudia Pina; Almeida, Hugo; Moreira, João Nuno; Lobo, José Manuel SousaTherapeutic uses of biological medicines are diverse and include active substances from different classes. This chapter provides an overview on the clinical applications of biological medicines containing hormones, blood products, and therapeutic enzymes. Currently, therapeutic hormones have 78 approved medicines, including insulin and analogs, glucagon and analogs, growth hormone, gonadotropins (follicle-stimulating hormone, luteinizing hormone, and human chorionic gonadotropin), thyroid-stimulating hormone, and parathyroid hormone. In contrast, recombinant blood products, and particularly blood factors, anticoagulants, and thrombolytic agents, incorporate 49 approved biological medicines. Regarding recombinant therapeutic enzymes, there are 22 approved medicines. Among the referred biological medicines, there are six biosimilar hormones, and no biosimilars have been approved for recombinant blood products and therapeutic enzymes, which is unexpected.Current investigations on recombinant hormones, recombinant blood products, and therapeutic enzymes seem to follow the same directions, searching for alternative non-injectable administration routes, development of new recombinant molecules with improved pharmacokinetic properties and discovering new clinical applications for approved medicines. These approaches are showing positive results and new medicines are expected to reach clinical approval in the coming years. Future prospects also include the approval of more biosimilar medicines.
- Insights on the formulation of recombinant proteinsPublication . Ribeiro, Rita; Abreu, Teresa Raquel; Silva, Ana Catarina; Gonçalves, João; Moreira, João NunoRecombinant proteins are large and complex molecules, whose therapeutic activity highly depends on their structure. Formulation of biopharmaceuticals aims at stabilizing protein conformation, promoting its efficacy, and preventing safety concerns, such as immunogenicity. Currently, the rational design of formulations is possible due to the availability of several techniques for molecule characterization and an array of both well-known and new excipients. Also, high-throughput technologies and Quality by Design approaches are trending and have been contributing to the advancement of the field. Still, there is a search for alternatives that ensure quality of the medicines through its life cycle, particularly for highly concentrated formulations, such as monoclonal antibodies. There is also a demand for strategies that improve protein delivery and more comfortable administration to the patients, especially with the arising of recombinant proteins in the treatment of chronic diseases, such as autoimmune conditions or heart diseases. In this chapter, current and future advancements regarding recombinant protein formulation and its impact in drug development and approval will be addressed.