Transcript Diapositiva 1

[email protected]
www.aretaint.com
ARETA INTERNATIONAL S.r.l.
The Reliable Partner for the Development of
Biodrugs in the field of Advanced Therapies
From the development of cell line to the final doses for patients
THE QUALITY AS
BUSINESS MODEL
THE
COMPETENCES
All company is ISO 9001:2000 certified since its founding (1999)
High Containment Production Plant for cell culture
GMP Authorized by the Italian Ministry of Health (in compliance with European Law)
Quality Agreement where necesssary
High skill in the development of biodrugs
(cells, antibodies, rec proteins)
Tumors,,CNS and Metabolic Diseases as Targets
THE RESEARCH
Collaboration with Italian and Int. Research Inst.
Partecipation to National and Int. Res. Projects
20% of the staff in dedicated to Research
THE PORTFOLIO OF
PRODUCTION
Process developmment
Production of lots for pre-clinical and clinical studies
Filling in asepsis of bags, vials…and media fill
QC and Safety tests set up and validation
Batch release by in house Qualified Person
ARETA OPERATES AS CUSTOMIZED CMO
WHY CHOOSE US
• ON A CONTRACT BASE
• IN PARTNERSHIP FOR CODEVELOPMENT
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HIGH COMPETITIVENESS
FLEXIBILITY
TIMING
TAILORED BATCHES (also SMALL)
PRICING
INNOVATIVE APPROACH TO MANUFACTURING
A New International Strategic Alliance
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Biotechnology, Development of
Advanced Therapy Drugs
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New formulations, pharmaceutical
chemical and bio-analyses,
pharmacokynetics
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Drug development/registrations;
international Business Development