Valentina Gualato, Ph.D. Process Development Scientist

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1 COMPANY PRESENTATION Quality and Innovation Valentina Gualato, Ph.D. Process Development Scientist

2 MISSION areta international is a biotech company dedicated to the contract development and manufacturing of biotechnology products and cell-based medicines.

3 HEADQUARTERS GERENZANO (VA) - ITALY ADMINISTRATION GMP FACILITY QC WAREHOUSE R&D LABS

4 HISTORY 1999 Foundation of Areta with private capital, as a spin-off of cell biology labs of Lepetit Research Center (subsidiary of multinational company) 2004 GMP authorization by AIFA (Italian Drug Agency) for a Cell Therapy product for Phase I and II clinical trials 2008 GMP facility revamping: 2X surface area and 4X production capability 2012 Periodic inspection for GMP-compliance, passed with no major observations 2012 Holding F.I.S. acquires a strategic stake in Areta, to strenghten the company s position as the ideal partner for the development of innovative therapies

5 WHERE WE ARE TODAY 2014 Experienced Contract Development and Manufacturing Organization, with GMP-inspected facility, authorized to produce investigational drugs of the following categories: Cell-based medicines Recombinant therapeutic proteins and monoclonal antibodies Plasmid DNA for therapeutic vaccination We can formulate and release the finished dosage, through in-house: Final filling and finishing (+ lyophilization) Chemical and microbiological analysis

6 HOLDING F.I.S. Holding F.I.S. is a privately owned Italian holding company. Together with its affiliates it represents a leading example of ethics, customer focus, and technical excellence. F.I.S. - Fabbrica Italiana Sintetici S.p.A. and Delmar Chemicals Inc., engaged in the development and manufacturing of APIs and intermediates for the worldwide pharmaceutical industry. Holding F.I.S. PHF SA, conceived as a "project engine" in the pharmaceutical, nutritional and cosmetic business.

7 AREAS OF ACTIVITY Pre-clinical development: high-quality, GMP-like material for toxicology and non-clinical studies Clinical development: supply for Phase I, II and III clinical trials of Biotechnology products and Advanced Therapies Phase Pre-clinical Clinical trials Large scale Development stage R&D Phase 1 Phase 2 Phase 3 Market

8 CORE COMPETENCES Monoclonal antibodies Products from cells Recombinant proteins Tissue engineering Cells and tissues as products Cellular therapy

9 PLATFORMS FOR DEVELOPMENT

10 RECOMBINANT PROTEIN AND ANTIBODY PRODUCTION A complete platform for development Bioinformatics study on protein properties Choice of suitable strain DNA codon optimization Gene synthesis Cloning in expression vector Trasformation and screening Product Scale-up in disposable bioreactor Set-up of purification strategy Fermentation

11 ADVANCED THERAPIES Regenerative medicine and cell therapy platform: from tissue samples to potent therapeutical applications Biopsy of donor tissue Cutting and enzymatic digestion Seeding in flasks Expansion Freezing of Master Cell Bank Thawing, expansion and preparation of bags for reinfusion

12 APPLICATIONS OUR EXCELLENCE IN DEVELOPMENT AND MANUFACTURING Here is our approach to early-stage programs: Medium Development Upstream Process Development Downstream Process Development Master and Working Cell Banks We support product development through all the steps necessary for IND filing Drug candidate IND / IMPD READY Phase I Phase II Phase III Custom Assay Development Regulatory Support We supply the GMP finished product for the execution of the clinical trials Analytical Package GMP Manufacturing Validation

13 TECHNOLOGIES IN PRODUCTION Our manufacturing facility is exclusively based on single-use technology Modular scale-up of production Main advantages: No cleaning validation No cross-contamination Fast turnover of batches Only produce the right amount that you need, when you need it

14 FILL AND FINISH Customized solutions for filling of liquid dosages in vials or bags Tailored handling of small amounts for early stage clinical trials Virtually no product losses Labeling and packaging Stability studies Final filling and finishing of vials or bags Lyophilization of final product (including lyophilization studies, if required)

15 QUALITY CONTROL AND PRODUCT ANALYSIS Product characterization Flow cytometry (FACS) for cell surface markers characterization Host Cell Proteins (HCP): production of custom antisera Process-related impurities Sterility and endotoxins Microbial count (TAMC, TYMC) Customized assays Stability studies (ICH) -20 ± 5 C 5 ± 3 C 25 ± 2 C, 60% ± 5 RH 30 ± 2 C, 65% ± 5 RH 40 ± 2 C, 70% ± 5 RH Other analysis SDS-PAGE (also 2D) IEF, WB HPLC Potency ELISA Cell-based tests

16 CONTACTS aretainternational Via Roberto Lepetit, 34 l Gerenzano (VA), Italy l tel fax l

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