DYNAMIC STRUCTURE

EXCELLENCE LEADING TO GROWTH

DYNAMIC STRUCTURE THAT FAVORS SYNERGY THROUGH COLLABORATION

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.

1.100 M2

PROCESS DEVELOPMENT SITES

13.700 M2

PRODUCTION SITES

DYNAMIC INTEGRATION, A NOVEL VISION IN THE INDUSTRY

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.

BUENOS AIRES PROCESS DEVELOPMENT SITE

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.

1.100 M2

PROCESS DEVELOPMENT SITES

SANTA FE PROCESS DEVELOPMENT SITE

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.


BUENOS AIRES PRODUCTION SITE

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.


SANTA FE PRODUCTION SITE

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 between public and private sectors.


FINISHED PRODUCTS QUALITY CONTROL SITE

This site is fully engaged in quality control procedures for finished products. Investments in dedicated equipment led to significant achievements for the AMEGA Biotech project.

450 M2

FINISHED PRODUCTS QUALITY CONTROL SITE

PRE-CLINICAL AND CLINICAL SITE

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.

520 M2

PRE-CLINICAL AND CLINICAL SITE

CORPORATE OFFICE

Since 2006 our corporate office, not only coordinates and guarantees integration among all sites and activities of AMEGA BIOTECH through the managers and heads of the different departments, but also conducts the strategic and commercial destiny of the company.