AMEGA Biotech is one of the first biosimilars producers to integrate all the processes leading to a biotech Finished Dosage Form. From cell engineering to API production and Finished Dosage Forms manufacturing, the company owns the know how and technologies to develop a wide range of biosimilars.
AMEGA Biotech is committed to providing adequate confidence that its products will satisfy the requirements for quality. In this context, cGMP standards became a central framework for our production activities and for the design of our production sites.
At present, the organization’s production processes are carried out at the sites located in Latinamerica, supported by strong development, pre-clinical, clinical and Quality Control platforms.
Our processes and workforce at production facilities deliver consistent product quality and translate directly into increased productivity and eficiency.
From the Active Pharmaceutical Ingredient (API) to the Finished Dosage Form (FDF).
Our model combines the synergy and collaboration from a range of companies, professional staff, universities, scientific organizations, government and strategic alliances with whom we build long term cooperative agreements.
The site was founded in 1998 and focuses on the development, production, purification, characterization and testing of a broad range of recombinant products. The site is responsible for Master Cell Bank and Working Cell Bank generation.
Located at Universidad Nacional del Litoral, this site has a pilot plant for scaling up and conducts the development of new processes and optimization or validation of existing ones at the development stage. Sharing facilities and equipment resources with the University, the department is a national example of the successful integration of public and private sectors.
This production site started operations in December 2005, in a surface area of 1.500 m2 arranged into two independent production areas for eukaryotic and prokaryotic production. The site houses full Upstream and Downstream processes for obtaining the Active Pharmaceutical Ingredients, ready for its formulation and filling, including full analytical capabilities, microbiology and cell-based assays.
The plants were built following the highest international standards in the production of biopharmaceutical products. With a total area of over 10,000 m2, plants located in the Parque Tecnológico Litoral Centro (Santa Fe) have significantly increased our production capacity, allowing access to world markets.
This site is fully engaged in quality control procedures for finished products and investments in dedicated equipment led to significant achievement for the AMEGA Biotech project.