Menarini Biotech is a fully integrated CDMO specializing in first-in-class biotherapeutic development and manufacturing of biologics. Established in 2003, Menarini Biotech’s mission is to provide high-quality, bespoke end-to-end services for biopharm companies from cell line development to GMP manufacturing of drug candidates. Our Quality System complies with AIFA/EU. Menarini Biotech works also in accordance with highest ISO certifications such as ISO-14001, ISO-45001 and ISO-50001.
We offer twenty years of experience in lead candidate selection and optimization of cell lines, process and analytical development, process optimization as well as drug substance and drug product manufacture from early clinical to commercial phase.
Our track record
The Headquarters of Menarini Biotech are located in the greater Rome area (Italy) in a cutting-edge pharmaceutical campus. The Italian site boasts an area dedicated to process development, an area dedicated to large scale production activities, including all the necessary support services (warehouse, offices and utilities) and a separate area dedicated to quality control services.
The production of active substances for clinical trials I, II and III takes place in two segregated suites in class D clean room, with 2X1,000L and 3X200L bioreactors (UNI EN ISO 14001:2004; OHSAS 18001).
The purification steps take place in class C clean room (UNI EN ISO 14001:2004; OHSAS 18001) with pre-viral and post-viral suite separation.
Menarini Biotech inaugurated the UK branch of its process development laboratories in March 2018 at the newly constructed Thames Valley Science Park located in Reading, 42 miles from London, UK.
The Reading site is dedicated to support the evaluation of new technologies and PoC (Proof of Concept) early phase and preclinical studies. With fully equipped state of the art laboratories its technical activities are focused on establishing Scale-up and Scale down model processes, determining operational limits, facilitating technology transfer (TT) of upstream, downstream and in-process analytical methods and providing the technical support needed during TT. Dedicated laboratories to develop, optimize and execute analytical assays including chromatographic analyses, electrophoretic analyses, immunoenzymatic assays and cell based assays.