2015 FOYA Award for facility integration Multipurpose Biologics and Vaccines Production Facility. IDT Biologika 2015 FOYA Award Facility Integration

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1 2015 FOYA Award for facility integration Multipurpose Biologics and Vaccines Production Facility 1

2 Agenda ABOUT IDT BIOLOGIKA FACILITY HIGHLIGHTS AND INNOVATIVE FEATURES BUILDING CONCEPT AND PROJECT OVERVIEW 2

3 Agenda ABOUT IDT BIOLOGIKA FACILITY HIGHLIGHTS AND INNOVATIVE FEATURES BUILDING CONCEPT AND PROJECT OVERVIEW 3

4 General information and strategic business units an innovative privately-held company with more than 90 years of experience in research, development, manufacture and distribution of biologics for the global protection of human and animal health VACCINES Long-term partnerships in bacterial and viral vaccines Services from development to commercial production PHARMACEUTICALS Long-term partnerships in the area of sterile preparation of medications (parenterals), including freeze-drying and packaging services from development to commercial production ANIMAL HEALTH Development, authorization, marketing and sales of biologic solutions, in particular vaccines, for animal health FIELD: TECHNOLOGY 35 % FIELD: TECHNOLOGY 35 % FIELD: OWN BRAND AND OWN PRODUCTS / OWN TECHNOLOGY 30 % 4

5 Facts and Figures Owners Hartmut, Carsten und Stefan Klocke via Klocke Holding GmbH Executive Management Dr. Ralf Pfirmann (CEO), Dr. Andreas Neubert (CSO) Staff 1,250* (2014) Revenues 172 million* (2014) Customers Worldwide Research and Development 8% of sales (into own brand animal health products) Investments More than 300 Mio. since 1993, of which more than 100 Mio. since 2011 Inspections IDT has been successfully inspected numerous times by the FDA and EMA and other agencies. Klocke Holding GmbH IDT Biologika is a Klocke Holding company. Klocke Holding companies are specialized in the manufacture and packaging of drugs, vaccines and cosmetic products. As a traditional family-owned company, Klocke Holding employs a workforce of more than 1,800 people in Europe and the USA. The group's six locations offer comprehensive services in biotechnology, pharmacy and packaging. * unaudited numbers 5

6 Manufacturing and Sales Locations RIEMS WASHINGTON D.C. DESSAU DENMARK NETHERLANDS EUROPE FRANCE USA SPAIN GERMANY Sales Service All functions (Dessau) Production, research, development, quality (Riems) Sales Service 6

7 IDT BioPharmaPark in Dessau, Germany Continuous expansion a full-fledged, scalable biopharma site in Dessau COMPANIES IDT Biologika TEW - Engineering, energy, water utility company, a Klocke Holding company Oncotec, a 50% subsidiary of Klocke Holding COMPANIES IN RESIDENCE Merz Dr. Felgenträger 7

8 IDT Biologika a biopharmaceutical company with long tradition The company's roots reach back to the Bakteriologisches Institut der Anhaltischen Kreise founded in Dessau. Commercial production began in 1925 with the manufacture of swine erysipelas vaccines. Rising demand for industrial production of sera for passive immunization of humans and animals led to the foundation of the Anhaltisches Serum Institut Dessau GmbH (ASID). Production of vaccines and diagnostic agents to combat infectious diseases in the newly formed Forschungsinstitut für Impfstoffe. TODAY Government programs to prevent and treat animal epidemics shaped the strategic direction towards research and production. Production capacities for human medicines were spun off. The company was renamed VEB Impfstoffwerk Dessau-Tornau. The entrepreneur Hartmut Klocke privatized the corporation as Impfstoffwerk Dessau-Tornau GmbH. IDT Biologika: Technology and manufacturing for breakthrough biologics supporting human and animal health worldwide. 8

9 Agenda ABOUT IDT BIOLOGIKA FACILITY HIGHLIGHTS AND INNOVATIVE FEATURES BUILDING CONCEPT AND PROJECT OVERVIEW 9

10 A multipurpose production facility for biologics and vaccines 40 million Euro building 12 million Euro isolator filling unit Expansion from two to three buildings Capacity for large scale commercial filling and freezedrying Focus on new recombinant and modified live human vaccines Certified to biosafety levels (BSL) 1 and 2 for live vaccines Fully operational since Oct

11 Facility integration - Built with future expansion in mind Integrated in two vaccine manufacturing buildings Since 1997/1998 in operation (Media preparation, Bulk manufacturing) 2 - Since 2008 in operation (Bulk manufacturing, human viral vaccines) 3 - Since 2014 in operation 3 Designed to be modular, fast and expandable Two additional freeze-dryers A second filling line 11

12 Key capabilities: Isolator vaccine filling unit High speed filling line with integrated real time process control and quality assurance technologies for up to 24,000 vials per hour (up to 100 million vials per year of freeze-dried and liquid presentations) A fully automated large scale loading and unloading freezedryer system A freeze-dryer shelf capacity of 40 m2, equal to at maximum 178,000 vials per batch 12

13 Key capabilities: Isolator vaccine filling unit (cont.) Most advanced aseptic technologies Continuous particle and microbiological tests Integrated camera inspections of vials 100% fill volume controls Vial coding and washing of capped vials 13

14 Isolator vaccine filling unit overview 1 Washing machine 2 3 Sterilization tunnel Filling machine Stoppering station Capping station Coding station Outside vial washer Tray loader 1 9 Loading system 10 Freeze-Dryer 14

15 Washing machine 15

16 Capping station 16

17 Tray loader views 17

18 Agenda ABOUT IDT BIOLOGIKA FACILITY HIGHLIGHTS AND INNOVATIVE FEATURES BUILDING CONCEPT AND PROJECT OVERVIEW 18

19 Building concept unique strategy designed for efficiency Three physical levels Strict horizontal division of the service areas and serviced areas Shortest supply and disposal routes Offices Ventilation Level Production Level Service Level 19

20 Integrated equipment suite represents significant contributions in operational excellence Three isolator segments for high flexibility and fast product changes Efficient product change over Industry leading aseptic isolator technology High level safety eliminates risk of cross contamination 20

21 Project overview - ambitious project timelines Excellence in project execution Regular meetings with joint project team/experts (operating company, quality assurance, general contractor, architect and technical planning) Monthly reports Budget control 2011 (Q3) Regulatory advice (FDA) 2011 (May) Tentative start of construction 2013 (Oct) Technical Completion 2014 (Jul) GMP inspection (German authorities) 2014 (Sep) Qualification 2014 (Oct) Manufacturing Authorisation 21

22 Choice for best-in-class and innovative suppliers The architect/designer for the project was Heene + Proebst, recognized for their integrated planning processes with the early inclusion of building technology, structural and process planning, for the creation of future-proof and flexible production structures, maximizing benefit for the client. 22

23 Choice for best-in-class and innovative suppliers (cont.) Process engineering was provided by Bideco Bio-und Pharmasysteme, specialists in the fields of biotechnology and pharmaceutical processing, with experts in validation and GMP. IDT chose Groninger & Co. GmbH for its best-in-class, pharmaceutical vial filling technologies. IDT chose HOF Sonderanlagenbau GmbH, known for state-of-the-art freeze-drying components featuring innovative loading and unloading systems. For isolator technology, SKAN AG, the largest supplier and technology leader for aseptic isolators in the pharmaceutical industry, was chosen for their industry leading know-how, quality and experience in qualification of aseptic isolators. 23

24 Results achieved: IDT Biologika now offers one of the most dynamic facilities designed for biomedical products manufacturing. Its vaccine development team are experts in live viral vectors increasingly utilized in the development of novel vaccines, making the company a fully integrated development and production operation at one site, an essential requirement of time sensitive projects. Accordingly, the company is able to accommodate the development, testing and manufacture of vital vaccines and other biological products for the world s leading biopharmaceutical industries. 24

25 FOYA Judges Panel Conclusion The highly automated manufacturing facility for filling and freeze drying is designed to be modular, efficient and expandable. The site s layout was devised to guarantee the shortest supply and disposal routes. Design of the integrated equipment suite represents significant contributions in operational excellence resulting in efficient product change over and increased efficiency. 25

26 IDT BIOLOGIKA Category Winner for Facility Integration 26

27 Advance Vaccines and Biotherapeutic Projects with IDT Biologika 27