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.
2 PRODUCTION SITES
2 process development sites
1 corporate office SITE
1 clinical and pre-clinical trials site
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
This site was founded in 1998 and structural analytical studies for all our products, fermentation process development and cell bank characterization are carried out at this location.
DEVELOPMENT, FERMENTATION, PURIFICATION, CHARACTERIZATION AND TESTING
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 production in mammalian
and bacterial cells.
The site houses
full Upstream and Downstream
processes for obtaining the Active
Pharmaceutical Ingredients, ready
for its formulation and filling,
including full analytical capabilities.
Upstream
Downstream
SANTA FE PRODUCTION SITE
Facilities were built following the highest international standards in the production of biopharmaceutical products. Located in the Parque Tecnológico Litoral Centro (Santa Fe), these facilities allowed increased production capacity and access to global markets.
BUENOS AIRES CLINICAL
AND PRE-CLINICAL SITE
This site includes animal facilities and histopathology labs. Our inhouse preclinical platform facilitates a full and stronger product history at our own facilities and increases knowledge on our own products.
An experienced clinical team oversees conduction of clinical studies, study protocols and data confirming quality, safety and efficacy of our products.
INFORMATION
Libertador Building, BUENOS AIRES
The building houses offices of Administration and Finance, Finished Product, Regulatory Affairs, Local Sales, International Sales, Quality, Research and Development, P&C and General Management.
