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Patrick HIBLE Senior Pharmaceutical / Biotechnology Expert

PROFILE Over thirty years' experience in design (from conceptual design to validation) of pharmaceutical, biopharmaceutical, diagnosis and animal health projects. Eight years' experience in the area of fine chemicals and food additives as Project Engineer (four years) and Production Manager (four years). Patrick as biopharmaceutical expert has managed many Conceptual design and Basic Engineering phases of upstream and downstream biopharmaceuticals projects in the field of vaccines, r-DNA proteins, plasma derivatives and cellular / gene therapy products in an international environment  :  

Education & Qualifications • Facultad de Ingeniería Química: Universidad Nacional de Buenos Aires

(U.N.B.A.) M. Sc. Chemical Engineer

• Université Paris Sud (XI), Orsay, France General and financial management

• The Center of Professional Advancement, Amsterdam, Netherlands: Design and validation of biotechnological & pharmaceutical production facilities

Languages French English (fluent) Spanish (fluent) German (basic) Date of Birth 1950 Nationality § French

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Patrick HIBLE Senior Pharmaceutical / Biotechnology Expert

RELEVANT EXPERIENCE 1994 – 2016_ TECHNIP, Paris - France: Senior Process Biotech Expert SANQUIN - Amsterdam, Netherland.

- Feasability study review for a production facility extension and/or grass root project for human Plasma derivative products.

Confidential – Buenos Aires, Argentina

- WHO GMP’s Mock Audit of a vaccine formulation, filling and packaging facility. AFM – GENETHON – Evry, France

- Cellular Therapy and Genetic Therapy products. Extension of a Development and Clinical trial production and Greenfield commercial production Feability studies and Conceptual Design.

CAF – DCF / SHIRE - Neder-Over-Heembeek, Belgium.

- Production facility extension for purification of a human Plasma derivative product. Feasability study: Layout and process conceptual design.

Confidential – Hsinchu, Taiwan

- WHO GMP’s Mock Audit of a new bulk vaccine facility design. LFB – Les Ulis, France

- New Thawing workshop and fibrinogen production facilities from plasma. Layout and process conceptual design.

Confidential – Hyderabad, India

- WHO GMP’s Mock Audit of a vaccine production. CAF – DCF / BAXTER - Neder-Over-Heembeek, Belgium.

- Extension Fractionation Plasma production facilities for 2 intermediates. Layout and process conceptual design.

INNOVAX - Xiamen Biomedical Park, China.

- New production site for human vaccines (HEV and HPV) based on recombinant E. coli used in manufacturing of virus-like particle (VLP’s). Upstream & Downstream processes. Vials and pre-filled syringes filling processes. Conceptual Design.

CEVA HUA DU - Beijing, China.

- Site Master Plan of biological vaccine Manufacturing Plant (live and inactivated vaccines) produced by bacterial fermentation, cell culture and viral infected eggs incubation.

CEVA ANIMAL HEALTH / HENTONG – Neijing, Sichuan, China.

- New Greenfield Manufacturing Plant of veterinarian products in liquid, topics, oral solid forms and liquids and solid sterile forms. Feasibility study.

MINHAI BIOTECHNOLOGY - Beijing, China.

- New production facilities for human vaccines: Bulk processes based on viral cell culture and bacterial fermentation including conjugation of polysaccharides. Filling processes: vial filling/freeze drying and pre-filled syringes line. Conceptual Design and Basic Design.

CELSIUS - Montevideo, Uruguay

- New Multipurpose Manufacturing Plant of pharmaceutical products in liquid, topics, oral solid forms and sterile liquids forms. Basic Design.

GENOPOLE - Evry, France.

- Bioproduction facility. Layout and process feasibility study (fermentation and downstream processing).

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Patrick HIBLE Senior Pharmaceutical / Biotechnology Expert

CAF - DCF - Neder-Over-Heembeek, Belgium. - Extension Fractionation Capacity (Plasma derivatives production facilities). Layout and process

conceptual design. SANOFI PASTEUR - Val de Reuil, France.

- New vial filling and freeze drying facilities with isolation technology for a vaccine (Dengue). Layout and process design lead. Conceptual Design.

LFB / HEMOBRAS – Goiana, Brazil.

- Grass root bulk manufacturing plant of plasma derivatives involving cryoseparation, Cohn fractionation and purification (chromatography, ultrafiltration, nanofiltration). Conceptual and Basic Design.

LFB – Saudi Arabia

- Bulk manufacturing facilities for plasma derivatives products. Layout and process design including complete segregation between pre and post virus inactivation. Conceptual design.

SANOFI PASTEUR - Shenzhen, China.

- Grass root facilities for Flu vaccine. Conceptual, Layout including BSL2+ containment and process leader. Basic Design.

LEO PHARMA - Vernouillet, France

- New bulk syringes filling line with isolation technology. Preliminary and Basic of Design. TRANSGENE - Illkirch, France.

- Gene Therapy clinical trial (phase III) and production manufacturing facilities (BSL2 / BSL3). Conceptual design, layout, process.

1986 – 1994_ SANOFI, Paris - France: Project Manager

Human health and biotechnology - Unit for production and packaging of clinical trial products, Research Center in Montpellier, France. - Biotech pilot plant for production of clinical products derived from recombinant DNA micro-organisms,

coordination of an international team (USA, England), Biotech Research Center in Labège, France. - Conceptual studies of a pilot plant for mammalian cell culture, Biotech Research Center. Labège, Fr. - Production facilities for hGH (human Growth Hormone) by rDNA bacteria technology. Aramon, France. Hospital - Equipment installation coordination of two hospitals (Peru, Venezuela) Diagnostics - Bacteriology and immunological products: Site Master plan. Steenvorde, France. - Conceptual studies for a production unit for reactive products used in biological analysis tests.

Steenvorde/Chaska, France/USA. Veterinary - Conceptual design of a formulation unit for penicillin parenteral products. - Site Master plan. Libourne, France.

1982 – 1986_ CECA/SATIA (ELF AQUITAINE), Vélizy- Fr : Project Engineer

Fine specialty chemistry - Active carbon, Zeolites, molecular sieves. France. Texturing agents and food additives - Pectin, Alginic acid. France

1976 – 1980_ CIBA GEIGY, Zarate - Argentine: Production Manager

Dyestuff division - Staff training and start-up of the new production grass roots site. - In charge of one of the three new production area.