Technology transfer model for the formulation stage in biological products for public health

Technology transfer is a tool used to absorb knowledge and technology, in addition to increasing a country’s technological innovation. In the health sector, it is no different, especially in times of outbreaks, epidemics and global pandemic. Therefore, tools that assist in the creation of public policies contribute to the research, development and innovation of new technologies to produce vaccines and medicines. Thus, it proposes a universal technology transfer model based on International guides from the World Health Organization, Parenteral Drugs Association and the International Society of Pharmaceutical Engineering. It was concluded that the model ensures reliability between the parties and promotes a dynamic and rapid methodology for application in public health in the country. Mini Review Technology transfer model for the formulation stage in biological products for public health Jorge L Magalhães1,2*, Alessandra L Viçosa3, Giselle Ribeiro de Barros4 1Departamento de Química Orgânica, Instituto de Química, Universidade Federal Fluminense, 24020150 Niterói, RJ, Brazil 2Global Health and Tropical Medicine, GHTM, Instituto de Higiene e Medicina Tropical, IHMT, Universidade Nova de Lisboa, UNL, Lisboa, Portugal. 3Instituto de Tecnologia em Fármaco, Fundação Oswaldo Cruz, Rio de Janeiro, RJ, Brazil 4Biomanguinhos, FIOCRUZ, Final Processing Department, Brazil Received: 04 May, 2020 Accepted: 25 May, 2020 Published: 26 May, 2020 *Corresponding author: Jorge L Magalhães, Departamento de Química Orgânica, Instituto de Química, Universidade Federal Fluminense, 24020-150 Niterói, RJ, Brazil, E-mail:

and the private sector [3]. Immunobiologicals have a great impact on prophylaxis and reduced mortality in diseases caused by infection, especially for the needy population who do not have access to health services. Thus, TT is one of the strategies for a country to have access to technology to produce these drugs more quickly to serve the population [4,5]. In this way, this work allowed us to propose a model in order to subsidize evenly a TT methodology for the formulation of production processes.

Introduction
The pharmaceutical industry generates approximately US $ 1.3 trillion in drug production. It invests hard in research and development, innovation, marketing and distribution of medicines, which run through serums, vaccines and medicines in order to treat public health problems [1]. In this process, several technologies are used and, in order to accelerate business and innovations, pharmaceutical companies use technology transfer (TT) as a process to strengthen the development of new drugs [2,3]. TT is defi ned as "a logical procedure that controls the transfer of any product along with its documentation and professional expertise between development and manufacturing or between manufacturing sites" [4]. According to Mohite and Sangle [3], it has two sources of fi nancing: the public sector (including universities) Citation: Magalhães

Results and Discussions
According to WHO (2011) 80% of the world population does not have access to essential medicines. In this way, TT can become an excellent tool for pharmaceutical companies in developing or less developed countries, for example [6,7].
In the pharmaceutical industry, TT is used in processes such as the discovery and development of new drugs, from the beginning of the product's life cycle to large-scale commercialization. In addition, some of its objectives are to transfer the product within and between companies and the knowledge of the process, used as a basis for manufacturing, analytical tests, process validation and continuous improvement [3,8]. It is worth mentioning that TT serves to assist in the transition of the medicine from the research and development stage to the marketing stage, identifying the important information during this process and clarifying doubts in the TT of products for different manufacturing locations [3].
According to WHO [4], TT is a procedure that must follow pre-determined steps in order to transfer knowledge and previously acquired experience so that it can be developed or marketed by another company [4]. Technologies are transferred through different forms such as licensing, franchising, turnkey, joint ventures, subcontracting, scientifi c cooperation, among others [9]. The technology transfer project (PTT) in the pharmaceutical industry consists of planned and controlled actions based on well-defi ned acceptance criteria.
They must be used in the manufacturing process, analytical method, packaging component or any other step or process throughout the life cycle of the drug from a place of origin [10]. The management of a TT requires the creation of a multidisciplinary team that must be supervised so that the execution of the transfer activities and the routine activities are accomplished without any type of damage occurring in both.
Another important point to be considered is the interaction between the teams of the two companies, which must overcome problems such as language and time zone [10]. According to [11], understanding workfl ows in companies is a pressing need and process modeling is the best option for this understanding, allowing companies to improve their processes, be more effi cient, fl exible, present competitive advantages and improve their services for customers and society [11][12][13].

Ethics approval and consent to participate
Ethical approval was obtained from the institutional review board of INI/FIOCRUZ, fi nal opinion number 3.353.006. Data were kept confi dential and anonymous.

Funding
The project was partially funded by Biomanguinhos/ FIOCRUZ.