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Biotimize
CDMO
The Strategic Role of a Biologics CDMO in the Global South
Biologics CDMOs play a crucial role in driving innovation and strengthening pharmaceutical self-sufficiency in the Global South, particularly in Latin America and Brazil. Currently, over 80% of global biopharmaceutical productionis concentrated in the Northern Hemisphere, where high costs and long timelines limit access for emerging markets.
In Brazil and Latin America, the lack of local infrastructure for the development of biological APIs results in dependency on imports and elevated costs, restricting the region’s ability to innovate and meet its own demand. A national CDMO like Biotimize enables these processes to take place locally, reducing development costs by up to 50%and significantly shortening production timelines.
Beyond strengthening the regional biopharmaceutical market, a robust infrastructure in Brazil also benefits international pharmaceutical companies, which can leverage Biotimize’s state-of-the-art facilities to develop and manufacture high-complexity biological APIs within a strategic regulatory environment, with easier access to emerging markets.
With the right infrastructure, Brazil has the potential to become a global hub for biopharmaceutical production, attracting international investment and making innovative treatments more accessible to millions of people across the Global South and beyond.
Biotimize: A Local Solution
to Global Challenges
Biotimize is a local response to global challenges, contributing to a more resilient and sustainable healthcare system. Its strategic role in building a robust biopharmaceutical ecosystem in Brazil, along with its growing influence in the international market, reinforces its position as a leader in innovation and development.
With the start of construction of a new Good Manufacturing Practices (GMP) facility planned for 2025, Biotimize will be even better prepared to meet both local and global demands, solidifying its relevance as a key player in advancing global healthcare.
On its 20,000+ square meter site, Biotimize will build a new Research & Development center, along with its administrative headquarters, warehouse, utilities, and a GMP-compliant platform to produce clinical and commercial batches.
Following the CDMO models of Oxford University (UK), the new Biotimize production facility will support various biological API production platforms, including bacteria, yeast, mammalian cells, and viruses. Operating under GMP regulations, in compliance with the world’s most stringent regulatory agencies—such as ANVISA (Brazil), FDA (USA), EMA (Europe), and TGA (Australia)—the facility will primarily manufacture batches for Phase 1, 2, and 3 clinical studies. The entire facility will be equipped with single-use technology, enhancing agility and flexibility across production, purification, and fill-finish processes. This allows Biotimize’s partners to utilize the facility for clinical batch development and manufacturing, cell bank storage (a unique service in Brazil), and fill-finish of final products.
Additionally, 10,000 square meters of the site will be reserved for future expansion, enabling the construction of dedicated and independent platforms for the commercial-scale production of various biological API platforms.
Located 120 KM from the capital of São Paulo, the main commercial center in Brazil.
Being close to the most important research centers/universities in Brazil.
Being at the center of several industrial centers of biotechnology and bioprocesses such as Cristália and more.
