Menarini Biotech since 1986 represents The Center of Excellence in Italy for Biotechnology and is located in the Menarini Scientific Campus in Pomezia – Rome. Menarini Biotech embraces the highest standards of regulatory compliance (both European and FDA cGMP) and is licenced by the Italian Ministry of Health for the manufacture of clinical supply for human use.

We are experienced in producing recombinant proteins, DNA and MAbs and biosimilars from mammalian, hybridomas and micro-organisms. The modern development and manufacturing facilities have from 20 to 1500 litres working volume bioreactors for mammalian and hybridomas cells and from 20to 3000L for micro-organism together with disposable culture-ware capability. Purification systems scaled to match the cultivation/fermentation productivity from the bench to pilot plant through to industrial scale production.

Menarini Biotech Pipeline

Menarini’s R&D Pipeline comprises innovative products in the therapeutic areas as oncology, inflammation, cardiovascular diseases and haematopoiesis:

• Abagovamab: an anti-idiotypic antibody vaccine for ovarian cancer currently in Phase III clinical trials.

• Amediplase: a thrombolytic agent for treatment of acute myocardial infarct. The product is ready to enter Phase III trials.

• AJ-3: a recombinant enzyme Ketoprofene Esterase for the enatiomeric resolution of Ketoprofene. (dexketoprofen)

• GM-CSF produced in CHO cells as adjuvant for therapeutic peptide vaccines

We have also developed and manufactured bio-pharmaceutical product in the following indications:

• Oncology: Monoclonal antibodies (MAbs) including bispecific MAbs, chemical immunoconjugates, human/mouse chimeric MAbs, immunotoxins, human apoptosis modulators. produced in hybridomas, engineered CHO cells and bacteria, Plasmid DNA vaccines.

• Inflammation: Site directed mutagenesis of receptors involved in inflammation and pain for rational drug design.

• Haematopoiesis: Recombinant human cytokines, produced in CHO cells.

Mission:

- We support in-licensing activity of biologics and provide future business intelligence.

Menarini Biotech high quality expert supports In-Licensing activities of biologics and provides future business intelligence for the Menarini Group which is the largest Italian private owned Pharmaceutical Group with a turnover of 2,4 billion euros and over 12,000 staff worldwide and with a consolidated In-licence and co-marketing agreements with the main Europen, America and Japanese companies. We are interested in adding to our portfolio by In-licensing primarily focussing in large molecule. As far as advanced development opportunities are concerned, we do not have strict limitations to certain therapeutics areas, however our main interests include oncology, pain & inflammation, cardiovascular, gastrointestinal, and respiratory drugs, as well as antidiabetics and antibiotics/anti-infectives.

- We provide a high quality expert development, analytical and cGMP manufacturing services to third parties.

Menarini Biotech is a biopharmaceutical company that provides customized development and manufacturing services. With an highly skilled international staff, through experienced gain in developing and manufacturing bio-pharmaceuticals for the Menarini Group, we work closely with our customers to ensure the rapid cost effective success of their projects.

Menarini Biotech can manage all aspects of your project (including regulatory submissions) from pre-clinical to commercial production.

Menarini Biotech can provide Analytical Development and Structural characterization Services. Our analytical techniques have been successfully applied to all stages of a products lifecycle including biophysical comparability studies, stability studies and aggregation problem solving. According to guideline and compliant with cGMP we perform Quality Control testing on all incoming product/raw material. In addition, we conduct in-process testing as appropriate for the process. All of these tests can be validated for the custom product that is being manufactured in our manufacturing facility.

IN LICENCING EXPECTATION

We are interested in:

• Co-marketing agreements;

• In-licensing of late-stage-development and ready-to-market, patent protected, original products (both of chemical and of biotech origin);

• Co-development of new drugs (both of chemical and of biotech origin), at earlier development stage, in selected therapeutic areas (see below);

MANUFACTURING AND ANALITYCAL SERVICES EXPECTATION

Leveraging our proven expertise and experience, we develop flexible, customized solutions that meet your specific biologics-development criteria compliant with all standards of Good Practise of manufacturing and Quality Control for Biopharmaceuticals

Menarini Biotech want to meet biotechnology companies looking to outsource process development and manufacturing and quality control services from an established company with a strong track record.

We also seek companies that require a second source manufacturer for their commercialised products.