IDT Presentation

Transcription

IDT Presentation

2015 FOYA Award for facility integration
Multipurpose Biologics and Vaccines Production Facility
1
IDT Biologika – 2015 FOYA Award Facility Integration
Agenda
2
ABOUT
FACILITY HIGHLIGHTS
BUILDING CONCEPT
IDT BIOLOGIKA
AND INNOVATIVE
AND PROJECT
FEATURES
OVERVIEW
Agenda
3
ABOUT
FACILITY HIGHLIGHTS
BUILDING CONCEPT
IDT BIOLOGIKA
AND INNOVATIVE
AND PROJECT
FEATURES
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
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
FIELD:
TECHNOLOGY
35 %
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FIELD:
TECHNOLOGY
35 %
ANIMAL HEALTH
Development, authorization,
marketing and sales of
biologic solutions, in particular
vaccines, for animal health
FIELD:
OWN BRAND AND OWN
PRODUCTS / OWN
TECHNOLOGY
30 %
Facts and Figures
Owners
Investments
Hartmut, Carsten und Stefan Klocke
via Klocke Holding GmbH
More than €300 Mio. € since 1993, of which more
than 100 Mio. € since 2011
Executive Management
Inspections
Dr. Ralf Pfirmann (CEO),
Dr. Andreas Neubert (CSO)
IDT has been successfully inspected numerous times
by the FDA and EMA and other agencies.
Staff
1,250* (2014)
Revenues
€ 172 million* (2014)
Customers
Worldwide
Research and Development
8% of sales (into own brand animal health
products)
* unaudited numbers
5
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.
Manufacturing and Sales Locations
RIEMS
DENMARK
DESSAU
WASHINGTON D.C.
NETHERLANDS
EUROPE
FRANCE
USA
SPAIN
GERMANY
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 Sales
 All functions (Dessau)
 Sales
 Service
 Production, research, development,
quality (Riems)
 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
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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 “Forschungsinstitut für Impfstoffe”.
TODAY
Government programs to
prevent and treat animal
epidemics shaped the
strategic direction towards
research and production.
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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.
Agenda
9
ABOUT
FACILITY HIGHLIGHTS
BUILDING CONCEPT
IDT BIOLOGIKA
AND INNOVATIVE
AND PROJECT
FEATURES
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 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. 2014
10 IDT Biologika – 2015 FOYA Award Facility Integration
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
2
3
1
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
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
1
Washing machine
2
Sterilization tunnel
3
Filling machine
4
Stoppering station
5
Capping station
6
Coding station
7
Outside vial washer
8
Tray loader
9
Loading system
10
Freeze-Dryer
10
8
7
9
5
3
2
1
4
6
Washing machine
Capping station
Tray loader views
Agenda
ABOUT
FACILITY HIGHLIGHTS
BUILDING CONCEPT
IDT BIOLOGIKA
AND INNOVATIVE
AND PROJECT
FEATURES
OVERVIEW
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
Ventilation Level
Production Level
Service Level
Offices
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
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
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

IDT Presentation

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