This story highlights a unique partnership with Bio-Manguinhos for a new facility at the Health Biotechnology Industrial Complex (CIBS) in Santa Cruz, Rio de Janeiro, Brazil. Bio-Manguinhos is one of 16 technical-scientific units of Fundação Oswaldo Cruz (Fiocruz), established in 1900. Fiocruz is a leading Brazilian research institution focused on health solutions, generating scientific and technological knowledge, and playing a vital role in health research and policy in Brazil.
Bio-Manguinhos has been expanding its infrastructure and is set to operate a state-of-the-art plant in the Industrial District of Santa Cruz. The facility aims to increase the supply of vaccines and biopharmaceuticals for public health programs. It will house the Novo Centro de Processamento Final (NCPFI) – New Final Processing Center – along with dedicated quality assurance and control areas. The NCPFI handles the final steps in processing pharmaceutical products, such as packaging, quality control, and preparing the products for distribution or sale.
The NCPFI project underscores Bio-Manguinhos’ commitment to strengthening Brazil’s health biotechnology sector by supporting global health initiatives. By adhering to key global regulatory standards (Anvisa, WHO, EMEA, and FDA), the project ensures that Bio-Manguinhos is well-positioned to operate within Brazil and globally, maintaining the highest quality standards.
Strengthening Vaccine Production
Brazil is facing an increasing national demand for vaccines. The NCPFI project is designed to meet this need while contributing to global health requirements. It will position Brazil as a significant player in the biopharmaceutical industry. The new campus in Santa Cruz spans over 580’000 m², with 334’000 m² dedicated to development. Once completed, the facility is expected to produce approximately 120 million vials annually.
State-of-the-Art Manufacturing Facility
The NCPFI project, initiated in 2011 and officially started in 2017, involved extensive groundwork, including soil testing, environmental licensing, and equipment procurement. Major construction is ongoing, and key equipment like filling lines and lyophilizers has already been secured.
The facility will feature four isolator filling lines, three with integrated lyophilizers and one dedicated exclusively to liquids. These four state-of-the-art production lines provide a reliable basis for high-volume and high-precision manufacturing. Additional process equipment like formulation isolators, sterility test isolators, and downflow booths complete the facility’s holistic approach. The layout is optimized to enhance productivity and maintain strict safety standards.
Setting New Standards
Moreover, the NCPFI will be a global showcase for pioneering aseptic process applications. This includes the introduction of customized isolators for formulation processes. This application remains rare in the industry but will become increasingly the preferred choice for the future of biopharmaceutical production. By implementing these advanced systems, Bio-Manguinhos is not only enhancing its capabilities but is also setting a new global benchmark for even safer biopharmaceutical manufacturing.
