IDT Biologika – 2015 FOYA Award Facility Integration 1
2015 FOYA Award for facility integration Multipurpose Biologics and Vaccines Production Facility
IDT Biologika – 2015 FOYA Award Facility Integration 2
ABOUT
IDT BIOLOGIKA
Agenda
FACILITY HIGHLIGHTS AND INNOVATIVE FEATURES
BUILDING CONCEPT
AND PROJECT
OVERVIEW
IDT Biologika – 2015 FOYA Award Facility Integration 3
ABOUT
IDT BIOLOGIKA
Agenda
FACILITY HIGHLIGHTS AND INNOVATIVE FEATURES
BUILDING CONCEPT
AND PROJECT
OVERVIEW
IDT Biologika – 2015 FOYA Award Facility Integration 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
Long-term partnerships in bacterial and viral vaccines – Services from development to commercial production
35 %
VACCINES
FIELD: TECHNOLOGY
Long-term partnerships in the area of sterile preparation of medications (parenterals), including freeze-drying and packaging –services from development to commercial production
35 %
PHARMACEUTICALS
FIELD: TECHNOLOGY
Development, authorization, marketing and sales of biologic solutions, in particular vaccines, for animal health
30 %
ANIMAL HEALTH
FIELD: OWN BRAND AND OWN
PRODUCTS / OWN TECHNOLOGY
IDT Biologika – 2015 FOYA Award Facility Integration 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
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Manufacturing and Sales Locations
EUROPE
RIEMS
DESSAU
GERMANY
USA
WASHINGTON D.C.
SPAIN
FRANCE
DENMARK
NETHERLANDS
Sales
Service
All functions (Dessau)
Production, research, development, quality (Riems)
Sales
Service
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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
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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 “Forschungs-institut für Impfstoffe”.
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.
TODAY
IDT Biologika – 2015 FOYA Award Facility Integration 9
ABOUT
IDT BIOLOGIKA
Agenda
FACILITY HIGHLIGHTS AND INNOVATIVE FEATURES
BUILDING CONCEPT
AND PROJECT
OVERVIEW
IDT Biologika – 2015 FOYA Award Facility Integration 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 freeze-drying
Focus on new recombinant and modified live human vaccines
Certified to biosafety levels (BSL) 1 and 2 for live vaccines
Fully operational since Oct. 2014
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Facility integration - Built with future expansion in mind
Integrated in two vaccine manufacturing buildings 1 - Since 1997/1998 in operation (Media preparation, Bulk manufacturing) 2 - Since 2008 in operation (Bulk manufacturing, human viral vaccines) 3 - Since 2014 in operation
Designed to be modular, fast and expandable
– Two additional freeze-dryers
– A second filling line
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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 freeze-dryer system
A freeze-dryer shelf capacity of 40 m2, equal to at maximum 178,000 vials per batch
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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
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Isolator vaccine filling unit overview
Washing machine
Sterilization tunnel
Filling machine
Stoppering station
Capping station
Coding station
Outside vial washer
Tray loader
Loading system
Freeze-Dryer
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9
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2
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Washing machine
IDT Biologika – 2015 FOYA Award Facility Integration 16
Capping station
IDT Biologika – 2015 FOYA Award Facility Integration 17
Tray loader views
IDT Biologika – 2015 FOYA Award Facility Integration 18
ABOUT
IDT BIOLOGIKA
Agenda
FACILITY HIGHLIGHTS AND INNOVATIVE FEATURES
BUILDING CONCEPT
AND PROJECT
OVERVIEW
IDT Biologika – 2015 FOYA Award Facility Integration 19
Building concept – unique strategy designed for efficiency
Ventilation Level
Production Level
Service Level
Offices
Three physical levels Strict horizontal division
of the service areas and serviced areas
Shortest supply and disposal routes
IDT Biologika – 2015 FOYA Award Facility Integration 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
IDT Biologika – 2015 FOYA Award Facility Integration 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
2014 (Jul) GMP inspection (German authorities)
2014 (Sep) Qualification
2014 (Oct) Manufacturing Authorisation
2011 (May) Tentative start of construction
2011 (Q3) Regulatory advice (FDA)
2013 (Oct) Technical Completion
IDT Biologika – 2015 FOYA Award Facility Integration 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.
IDT Biologika – 2015 FOYA Award Facility Integration 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.
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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.
IDT Biologika – 2015 FOYA Award Facility Integration 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.”
IDT Biologika – 2015 FOYA Award Facility Integration 26
IDT BIOLOGIKA Category Winner for Facility Integration
IDT Biologika – 2015 FOYA Award Facility Integration 27
Advance Vaccines and Biotherapeutic Projects with IDT Biologika
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