2015 foya award for facility integration · idt biologika – 2015 foya award facility integration...

IDT Biologika – 2015 FOYA Award Facility Integration 1

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


ABOUT

IDT BIOLOGIKA

Agenda

FACILITY HIGHLIGHTS AND INNOVATIVE FEATURES

BUILDING CONCEPT

AND PROJECT

OVERVIEW


ABOUT

IDT BIOLOGIKA

Agenda


BUILDING CONCEPT

AND PROJECT

OVERVIEW


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


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


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


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


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


ABOUT

IDT BIOLOGIKA

Agenda


BUILDING CONCEPT

AND PROJECT

OVERVIEW


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


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

1 2

3


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


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


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

1

2

3 4

5 6

7

8

9

1

2

3

4

5

6

7

8

9

10

10


Washing machine


Capping station


Tray loader views


ABOUT

IDT BIOLOGIKA

Agenda


BUILDING CONCEPT

AND PROJECT

OVERVIEW


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


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


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


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.


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.


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.


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 Category Winner for Facility Integration


Advance Vaccines and Biotherapeutic Projects with IDT Biologika

2015 foya award for facility integration · idt biologika – 2015 foya award facility integration...

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