Fiocruz and MoH publish notice for construction of the largest vaccine factory in LA

On February 5, the Ministry of Health (MoH) and Fiocruz launched a public notice for the construction of the Industrial Complex of Biotechnology in Health (Cibs, in the Portuguese acronym). The document opens a bidding process for hiring investors interested in participating in the construction of a new complex of the Immunobiological Technology Institute of the Oswaldo Cruz Foundation (Bio-Manguinhos/Fiocruz), in Santa Cruz, in Rio de Janeiro. 

The Bio-Manguinhos director/Fiocruz, Maurício Zuma, said he was thrilled with the event, remembering that the Institute has reached this moment after going a long way of studies, meetings, and a lot of dedication. “We are clear and convinced of the strategic role that Bio-Manguinhos plays for the country. Brazil has imported a large number of biopharmaceuticals for several diseases. Our challenge, the challenge for all Fiocruz, is to overcome this dependence, which will be another great achievement for the institution. In this way, we will be able to fully meet all the SUS [Brazilian Public Health System] demands and still export vaccines whenever our assistance is required”.

The Fiocruz president, Nísia Trindade Lima, also emphasized the many shortcomings of the Brazilian health system in the technological area and noted that Cibs will make an important contribution to reducing this problem. “Cibs points not only to the present needs, such as those of the pandemic but mostly to the future, to the next challenges that the country will face in health. With this undertaking, the country takes a fundamental step to guarantee its autonomy in the immunobiological production”, she said.

The president commented that it will be with this type of investment that Brazil will have autonomy and reinforce its sovereignty, within a project that has as pillars citizenship, investments in health and technology, and social development. "Health is a development factor and the country project in which we believe includes this effort to strengthen research, innovation and science and technology for SUS".

Fiocruz president highlighted the importance of the project to Brazil's autonomy in the immunobiological production (photo: Peter Ilicciev)

Minister of Health, Eduardo Pazuello intervened after the president and stated his pleasure in being part of a moment that he classified as historic for the country. “We have the largest public health system in the world and it is with SUS that we can face the challenges that arise. With Cibs we will give a great reinforcement to Oswaldo Cruz's legacy and we will be able to project Brazilian public health for the next 100 years ”.

CIBS in the Public Health System (SUS)

The project will be the largest center for the production of biological products in Latin America and one of the most modern in the world. Thus, Bio-Manguinhos/Fiocruz will be able to increase the production capacity of vaccines and biopharmaceuticals four times - a number that may be even greater depending on the product mix - in order to give priority to the Brazilian population demands through the Public Health System (SUS). Such production will reinforce the country's self-sufficiency in the field of immunobiological, reducing external technological dependence. The Cibs represents a new impetus in national training: in addition to the new products of relevance incorporation to SUS, such as vaccines for the immunization schedule and biopharmaceuticals that treat chronic, rare, autoimmune, and oncological diseases, it will enable rapid responses in health emergency situations, such as the current Covid-19 pandemic.

For the project to be built, the investment will take place within a modality considered innovative within the Federal Government scope, called Built to Suit. Under this model, the financing will be private, paid in the form of rent, and with the equity reversion after the 15-year term. The investment is of the order of R $ 3.4 billion and foresees the generation of 5,000 direct jobs in this stage of works and 1,500 jobs for the operation of the enterprise.

With the published notice, potential investors will have a 120 days period for appropriation and study of the project to support the preparation of their proposals. After the conclusion of the bidding process, with the winner's approval and the signing of the contract, construction will begin in the second half of 2021. The forecast is that the first GMP buildings (Good Manufacturing Practices - Boas Práticas de Fabricação - BPF, in Portuguese) will start to be ready in about 24 months and that the entire Industrial Complex of Biotechnology in Health will be ready in four years. In parallel with the constructions, all mandatory validation processes will be carried out.

The Complex's land already has earthworks, buildings staking, blocks and strap constructions, and environmental compensation made with investments from the Ministry of Health, as well as the main production equipment acquisition.

The enterprise

The land of the Industrial Complex of Biotechnology in Health covers an area of approximately 580 thousand square meters. Only the new Final Processing Center (NCPFI), the main installation of the project, represents 334 thousand square meters of built area. The complex will initially consist of nine buildings, comprising two for formulating, filling, lyophilizing, and reviewing vaccines and biopharmaceuticals and the rest for packaging activities; raw material storage; finished product storage; quality control and guarantee; utilities in general; waste and effluent treatment plants; and administration. The land also has areas reserved for future expansions. 

The production capacity is estimated at 120 million vials of vaccines and biopharmaceuticals/year and may be expanded depending on the operating regime to be adopted. In doses, the capacity will vary according to the product mix and may be over 600 million doses/year. Currently, Bio-Manguinhos supplies vaccines with presentations of 1 dose, 5 doses, and 10 doses/bottle, and the expansion of the production capacity at Cibs also represents the possibility of incorporating new presentations. 

The final processing areas will incorporate cutting-edge technologies through the Advanced Aseptic Processing (AAP) philosophy, in line with new technological trends. These cutting-edge technologies make it easier to obtain certifications from regulatory agencies and international bodies – ensuring to the Institute the status of an immunobiological global supplier. The high level of applied automation will allow greater operational safety at a lower cost and also greater precision and guarantee in the final processing steps quality.

It is also a sustainable project, which will have panels for capturing solar energy; reservoirs to collect rainwater; a water reuse system; and the acquisition of materials with recycled content. In the initial stage, 30,000 trees have already been planted that will form an Atlantic Forest green belt to preserve the local biodiversity; among other initiatives. 

The new plant may, for example, enable the production of the new vaccine, such as the viral double (measles and rubella), whose clinical studies were recently concluded by Bio-Manguinhos, and the meningococcal C, which is in an advanced stage of studies phases II/III, in addition to new vaccine presentations from the Institute's portfolio (number of doses/bottle), to meet different SUS needs. 

So, the Institute reaffirms its important role in combating diseases preventable by vaccination, as well as in the treatment of chronic diseases such as rheumatoid arthritis, multiple sclerosis, and oncological diseases, including allowing the expansion of federal government programs through the incorporation of new immunobiological for the population.