#1 In Brazil
Brazilian universities, startups, and companies face enormous difficulties in developing biological Active Pharmaceutical Ingredient (API).
This clearly accounts for the low number of biopharma (monoclonal antibodies/ recombinant proteins from mammalian cells) products launched through entirely Brazilian research (only 3), the low translation rate of research to patents, the low capacity of biological manufacturing (only 2.19% of world manufacturing capacity in South America), the low number of active GMP certification facilities, and the high cost of importing biological products by the Brazilian government (USD 1.3 Bn in 2015).
One of the main causes for this scenario is the fact that Brazil does not have a biological Contract Development Manufacturing Organization (CDMO), despite the existence of more than 500 in the world. CDMOs are strategic for mitigating process risks and providing flexibility and speed to development of biopharmaceutical processes. The company will be the only GMP-certified facility (ANVISA/FDA) in Brazil to work on an “as a service” model (CDMO). Moreover, Biotimize will be the only one in South America that offers an end-to-end production service (from cell line development until fill and finish) and works also with adherent mammalian cells.
Today, Biotimize has already a wet lab for bioprocess development for pre-clinical material production in Piracicaba - São Paulo. For the expansion, Biotimize acquired a 3000 m2 (32,000 sf) parcel of land that will be used to construct the new biological R&D Center and CDMO in Piracicaba. This region was strategically chosen for factors such as:
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.
Being close to the Interoceanic Highway that is under construction.
Pre-Clinical Material Production (non - GMP)
Start of the CDMO Conceptual, Basic and Executive projects
CDMO Conceptual, Basic and Executive projects finalization
Start of the CDMO and R&D Center construction
R&D center inauguration & CDMO qualification
Biotimize’s CDMO (GMP certified facility) will be focused on the production of monoclonal antibodies/biosimilars and recombinant proteins from mammalian cells. The CDMO will have 3 upstream (UPS) suites and 1 shared downstream (DSP) suite, all under Biosafety Level 1 qualification.
The UPS suites 1 and 2 will operate up to a scale of 200-500 L in a single-use bioreactor (SUB) system, while the suite 3 will reach a production volume of 2000-5000 L (SUB). However, the UPS suites 1 and 2 are also designed to be able to increase the production capacity to 2000-5000 L as well in the future.
The DSP suite equipment will all be single-used as well and the structure will also be able to do the product fill and finish. The goal of the CDMO is to generate GMP-level cell banks, produce clinical materials (phase I-III), and commercial batches. On the other hand, the R&D Center will be versatile to attend to the development demands of other production platforms under the GLP (Good Laboratory Practice) environment. The R&D structure, all under Biosafety Level 2 qualification, will have a suite for molecular biology experiments, another suite for mammalian cells/ viral vectors/ oncolytic virus/ mRNA development, a third suite for recombinant protein production from microorganism, and a last one for purification. The R&D Center will be used for cell line development, process development, formulation development, analytical methods development, and pre-clinical material production.