EMU-PMP 2023: "Acquisition of equipment to complement a multi-user freeze-drying facility"

• Grant number: 23/16514-5
• Support Opportunities: Research Infrastructure Program - Small Medium Sized
• Start date: September 01, 2024
• End date: August 31, 2027
• Field of knowledge: Agronomical Sciences - Veterinary Medicine
• Principal Investigator: Rui Seabra Ferreira Junior
• Grantee: Rui Seabra Ferreira Junior
• Host Institution: Centro de Estudos de Venenos e Animais Peçonhentos (CEVAP). Centro Virtual de Toxinologia. Universidade Estadual Paulista (UNESP). Campus de Botucatu. Botucatu , SP, Brazil
• Associated researchers: Benedito Barraviera ; Carlos Roberto Prudencio ; Eliane Candiani Arantes Braga ; Suely Vilela

Abstract

Freeze drying is the process of removing water through sublimation. The technique consists of freezing the sample followed by removing the water directly into the solid state without passing through the gaseous state. The main objectives of the process are to maintain the characteristics, properties, physical, chemical and nutritional structures, in addition to increasing the product's shelf life. This process reduces oxidative denaturation, the product can be easily reconstituted, physical and chemical properties are preserved and ultimately hinders the proliferation of microorganisms. Given this fact, placing medicines on the pharmaceutical market presents a major challenge, which is maintaining the cold chain, which is expensive and has complicated logistics, therefore representing a limiting factor for the success of any product. Freeze drying is the technique used by the pharmaceutical industry to optimize the shelf life of a product, increasing its expiration date, as well as enabling its maintenance at room temperatures. The objectives of this scientific EMU will be to acquire medium-sized equipment to support and improve already standardized freeze-drying techniques, improving the performance of large freeze-dryers already installed and operating in CEVAP laboratories. The researchers involved place special emphasis on the current concept of Quality by Design (QbD), widely used in drug development. This concept prioritizes product design, involving knowledge of processes and properties, in addition to ensuring that the quality of the product to be generated is maintained throughout all stages of preparation, instead of being tested only in the final stages.For the development of a biopharmaceutical freeze-drying process to be successful, it is necessary to have means to monitor these parameters. The Cedex Bio, DSC 5+ and Lyostat 5 equipment will assist researchers in this regard, for the construction and validation of the freeze-drying methodology. The Thermocycler will evaluate the integrity of the DNA of freeze-dried microorganisms and the Moisture Analyzer will check the residual moisture in the freeze-dried product, that is, two important pieces of equipment for quality control and certification of results.The themes of the listed subprojects range from microorganisms of interest to public health; animal feed; pathophysiological experimental models; fish proteins for human and animal consumption; native and recombinant toxins generating candidate molecules; production of monoclonal antibodies, nanobodies and recombinant antigens; bioproducts used in nerve regeneration; vaccine antigens and protein synthesis, and bioproducts used in diabetic patients. This entire range of applications will require at some point the freeze-drying process to maintain product quality, facilitating transport and storage, increasing shelf life and ultimately lowering costs and production, optimizing financial resources.We can conclude that the freeze-drying process is extremely promising for reducing the moisture content in different materials, contributing to the preservation of their physical, chemical, biological and nutritional qualities. Furthermore, knowledge of the physical and thermal properties of freeze-dried products and their drying kinetics will contribute to the subsequent development of the mathematical model of freeze-drying, based on the laws of heat and mass transfer.In this way, the creation of a Facilities like this, to be unique in the State of São Paulo, which contains all the appropriate and necessary equipment to carry out the processes and experiments, in addition to qualified and qualified professionals to build and standardize these methods, becomes will be indispensable to assist in the development of internationally competitive national products.This EMU proposal is strongly associated with the CENTER FOR TRANSLATIONAL SCIENCE AND DEVELOPMENT OF BIOFARMACOS (CCD-FAPESP) (FAPESP Proc. No. 21/11936-3 (AU)