Menarini Biotech
Ardelia Basilica is an experienced Quality Assurance Specialist with a comprehensive background in the pharmaceutical and biotech industries. Currently at Menarini Biotech since May 2015, responsibilities include managing and authoring SOPs, batch record review, and quality risk management. Previous roles include Quality Assurance Packaging Expert at Novartis Vaccines and Diagnostics, where Ardelia ensured timely documentation approval and compliance with cGMP, and TPM Quality Assurance at Abbott Laboratories, focusing on project support and regulatory strategy. Additional experiences include roles at Pfizer, S4BT S.r.L., and Janssen, where key responsibilities encompassed technical training, documentation management, and adherence to GMP standards. Ardelia holds a Biology degree from the University of Naples "Federico II" and further education from the University of Basilicata.
Menarini Biotech
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Menarini Biotech (“MBH”) is a fast-growing, agile, fully integrated CDMO for biologics located in the greater Rome area, Italy. Established in 2003, Menarini Biotech’s mission is to provide fast and efficient, yet very customer-centric, world-class, high-quality, services for biotech companies from preclinical development to GMP manufacturing (Mammalian and Microbial) up to BSL-2. These include CHO cell line development and analytical development for standard and non-standard mAbs, and new molecular formats, e.g. bispecifics, ADCs, fusion proteins. Our Quality System complies with AIFA/EU GMP requirements.