{"id":4043,"date":"2022-04-26T22:38:16","date_gmt":"2022-04-26T22:38:16","guid":{"rendered":"http:\/\/amegabiotech.com\/?page_id=4043"},"modified":"2023-05-08T21:18:37","modified_gmt":"2023-05-08T21:18:37","slug":"nuestra-empresa","status":"publish","type":"page","link":"https:\/\/amegabiotech.com\/en\/nuestra-empresa\/","title":{"rendered":"OUR SITES"},"content":{"rendered":"
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DYNAMIC STRUCTURE<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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EXCELLENCE LEADING TO GROWTH<\/h1>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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DYNAMIC STRUCTURE THAT FAVORS SYNERGY THROUGH COLLABORATION<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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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\nFinished Dosage Forms manufacturing, the company owns the know how and technologies to develop a wide range of biosimilars.\u00a0<\/p><\/div><\/div>

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.<\/p><\/div><\/div>

At present, the organization\u2019s production processes are carried out at the sites located in Latinamerica, supported by strong development, pre-clinical, clinical and Quality Control platforms.<\/p><\/div><\/div>

Our processes and workforce at production facilities deliver consistent product quality and translate directly into increased productivity and eficiency.<\/p><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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2 PRODUCTION SITES\n<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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2 process development sites\n<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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1 corporate office SITE \n<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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1 clinical and pre-clinical trials site<\/h4>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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DYNAMIC INTEGRATION, A NOVEL VISION IN THE INDUSTRY<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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From the Active Pharmaceutical Ingredient (API) to the Finished Dosage Form (FDF).<\/strong><\/p><\/div><\/div>

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.<\/p><\/div><\/div><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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OUR SITES<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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\n\t\t\t\t\t\n\t\t\t\t\t\t\n\t\t\t\t\t\t\t\t\tBuenos Aires Production Site<\/span>\n\t\t\t\t\t<\/span>\n\t\t\t\t\t<\/a>\n\t\t\t\t<\/div>\n\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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BUENOS AIRES PROCESS DEVELOPMENT SITE<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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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.<\/p><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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DEVELOPMENT, FERMENTATION, PURIFICATION, CHARACTERIZATION AND TESTING<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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SANTA FE PROCESS DEVELOPMENT SITE<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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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.<\/p><\/div><\/div><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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\nBUENOS AIRES PRODUCTION SITE<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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This production site started \noperations in December 2005, in a\nsurface area of 1.500 m2 arranged\ninto two independent production\nareas for production in mammalian\nand bacterial cells.
The site houses\nfull Upstream and Downstream\nprocesses for obtaining the Active\nPharmaceutical Ingredients, ready\nfor its formulation and filling,\nincluding full analytical capabilities.<\/p>

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Upstream
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SANTA FE PRODUCTION SITE<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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Facilities were built following the highest international standards in the production of biopharmaceutical products. Located in the Parque Tecnol\u00f3gico Litoral Centro (Santa Fe), \nthese facilities allowed increased production capacity and access to global markets.<\/p><\/div><\/div><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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BUENOS AIRES CLINICAL
AND PRE-CLINICAL SITE\n<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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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.<\/p><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t

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INFORMATION<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/section>\n\t\t\t\t
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Libertador Building, BUENOS AIRES\n<\/h3>\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t
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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.<\/p><\/div><\/div><\/div><\/div>\t\t\t\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t\t\t<\/div>\n\t\t<\/div>\n\t\t\t\t

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estructura din\u00e1mica EXCELENCIA QUE ESTIMULA LA SUPERACI\u00d3N UNA ESTRUCTURA DIN\u00c1MICA QUE FAVORECE LA SINERGIA A TRAV\u00c9S DE LA COLABORACI\u00d3N AMEGA Biotech es una de las primeras plataformas de biotecnolog\u00eda que integra todos los procesos para obtener un producto farmac\u00e9utico biotecnol\u00f3gico. Desde la ingenier\u00eda celular hasta la producci\u00f3n del Ingrediente Farmac\u00e9utico Activo y la fabricaci\u00f3n del […]<\/p>\n","protected":false},"author":2,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"footnotes":""},"class_list":["post-4043","page","type-page","status-publish","hentry"],"_links":{"self":[{"href":"https:\/\/amegabiotech.com\/en\/wp-json\/wp\/v2\/pages\/4043","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/amegabiotech.com\/en\/wp-json\/wp\/v2\/pages"}],"about":[{"href":"https:\/\/amegabiotech.com\/en\/wp-json\/wp\/v2\/types\/page"}],"author":[{"embeddable":true,"href":"https:\/\/amegabiotech.com\/en\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/amegabiotech.com\/en\/wp-json\/wp\/v2\/comments?post=4043"}],"version-history":[{"count":104,"href":"https:\/\/amegabiotech.com\/en\/wp-json\/wp\/v2\/pages\/4043\/revisions"}],"predecessor-version":[{"id":5615,"href":"https:\/\/amegabiotech.com\/en\/wp-json\/wp\/v2\/pages\/4043\/revisions\/5615"}],"wp:attachment":[{"href":"https:\/\/amegabiotech.com\/en\/wp-json\/wp\/v2\/media?parent=4043"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}