IDT Biologika 2015 FOYA Award Facility Integration - PDF document

IDT Biologika 2015 FOYA Award Facility I
IDT Biologika 2015 FOYA Award Facility Integration 2015 FOYA Award for facility integrationMultipurpose Biologics and Vaccines Production FacilityIDT Biologika 2015 FOYA Award Facility Integration ABOUT IDT BIOLOGIKAAgendaFACILITY HIGHLIGHTS AND INNOVATIVE FEATURESBUILDING CONCEPT AND PROJECT OVERVIEWIDT Biologika 2015 FOYA Award Facility Integration ABOU

T IDT BIOLOGIKAAgendaFACILITY HIGHLIGH
T IDT BIOLOGIKAAgendaFACILITY HIGHLIGHTS AND INNOVATIVE FEATURESBUILDING CONCEPT AND PROJECT OVERVIEWIDT Biologika 2015 FOYA Award Facility Integration General informationandstrategicbusinessunitsan innovative privatelyheld company with more than 90 years of experience in research, development, manufacture and distribution of biologics for the global protectio

n of human and animal healthLongterm pa
n of human and animal healthLongterm partnerships in bacterial and viral vaccines Services from development to commercial productionVACCINESFIELD:TECHNOLOGYLongterm partnerships in the area of sterile preparation of medications (parenterals), including freezedrying and packaging services from development to commercial productionPHARMACEUTICALSFIELD:TECHNOLOGYDe

velopment, authorization, marketing and
velopment, authorization, marketing and sales of biologic solutions, in particular vaccines, for animal healthANIMAL HEALTHFIELD: OWN BRAND AND OWN PRODUCTS / OWN TECHNOLOGYIDT Biologika 2015 FOYA Award Facility Integration Facts and FiguresOwnersHartmut, Carsten und Stefan Klockevia KlockeHolding GmbHExecutive ManagementDr. Ralf Pfirmann (CEO), Dr. Andreas Neu

bert (CSO)Staff1,250* (2014)Revenues172
bert (CSO)Staff1,250* (2014)Revenues172 million* (2014)CustomersWorldwideResearch and Development8% of sales (into own brand animal health products)InvestmentsMore than 300 Mio. since 1993, of which more than 100 Mio. since 2011InspectionsIDT has been successfully inspected numerous times by the FDA and EMA and other agencies.KlockeHolding GmbHIDT Biologikais a Kloc

keHolding companyKlockeHolding companies
keHolding companyKlockeHolding companies are specialized in the manufacture and packaging of drugs, vaccines and cosmetic productsAs a traditional familyowned company, KlockeHolding 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

IDT Biologika 2015 FOYA Award Facility I
IDT Biologika 2015 FOYA Award Facility Integration Manufacturing andSalesLocationsEUROPERIEMSDESSAUGERMANYUSAWASHINGTON D.C.SPAFRANCENMARKNETHERLANDSSalesServicefunctions(Dessau)Production, research, development, quality RiemsSalesServiceIDT Biologika 2015 FOYA Award Facility Integration IDT BioPharmaParkin Dessau, GermanyContinuous expansion a fullfle

dged, scalable biopharma site in Dessau
dged, scalable biopharma site in Dessau COMPANIES IDT BiologikaTEW Engineering, energy, water utility company, Klocke Holding companyOncotec, a 50% subsidiary of KlockeHoldingCOMPANIES IN RESIDENCEMerzDr. FelgenträgerIDT Biologika 2015 FOYA Award Facility Integration IDT Biologika a biopharmaceutical company with long traditionThe company's roots reach back to

the BakteriologischesInstitutder Anhalt
the BakteriologischesInstitutder AnhaltischenKreise” 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 “AnhaltischesSerum InstitutDessau GmbH” (ASID).Production of vaccines a

nd diagnostic agents to combat infectiou
nd diagnostic agents to combat infectious diseases in the newly formed “ForschungsinstitutfürImpfstoffe”.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 ImpfstoffwerkDessauTornauThe entrepreneu

r Hartmut Klockeprivatized the corporati
r Hartmut Klockeprivatized the corporation as “ImpfstoffwerkDessauTornauGmbH”.IDT Biologika: Technology and manufacturing for breakthrough biologics supporting human and animal health worldwide.TODAYIDT Biologika 2015 FOYA Award Facility Integration ABOUT IDT BIOLOGIKAAgendaFACILITY HIGHLIGHTS AND INNOVATIVE FEATURESBUILDING CONCEPT AND PROJECT OVER

VIEWIDT Biologika 2015 FOYA Award Facil
VIEWIDT Biologika 2015 FOYA Award Facility Integration A multipurpose production facility for biologics and vaccines40 million Euro building12 million Euro isolator filling unitExpansion from two to three buildingsCapacity for large scale commercial filling and freezedryingFocus on new recombinant and modified live human vaccines Certified to biosafety levels (BS

L) 1 and 2 for live vaccinesFully operat
L) 1 and 2 for live vaccinesFully operational since Oct. 2014 IDT Biologika 2015 FOYA Award Facility Integration Facility integration Built with future expansion in mindIntegrated in two vaccine manufacturing buildingsSince 1997/1998 in operation Media preparation, Bulk manufacturing)Since in operation (Bulk manufacturing, human viral vaccines)Since in operation

Designed to be modular, fast and expand
Designed to be modular, fast and expandableTwo additional freezedryersA second filling line1 2 3 IDT Biologika 2015 FOYA Award Facility Integration Key capabilities: Isolator vaccine filling unitHigh 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 yea

r of freezedried and liquid presentation
r of freezedried and liquid presentations)A fully automated large scale loading and unloading freezedryer systemA freezedryer shelf capacity of 40 m2, equal to at maximum 178,000 vials per batch IDT Biologika 2015 FOYA Award Facility Integration Key capabilities: Isolator vaccine filling unit (cont.)Most advanced aseptic technologiesContinuous particle and micro

biological testsntegrated camera inspect
biological testsntegrated camera inspections of vials% fill volume controls ial coding and washing of capped vials IDT Biologika 2015 FOYA Award Facility Integration Isolator vaccine filling unit overviewWashing machineSterilization tunnelFilling machineStoppering stationCapping stationCoding stationOutside vial washerTray loaderLoading systemFreezeDryer1 2 3

4 5 6 7 8 9 1 2 3 4 5 6 7
4 5 6 7 8 9 1 2 3 4 5 6 7 8 9 10 10 IDT Biologika 2015 FOYA Award Facility Integration Washing machineIDT Biologika 2015 FOYA Award Facility Integration Capping stationIDT Biologika 2015 FOYA Award Facility Integration Tray loader viewsIDT Biologika 2015 FOYA Award Facility Integration ABOUT IDT BIOLOGIKAAgendaFACILITY HIGHLIGHTS AND

INNOVATIVE FEATURESBUILDING CONCEPT AN
INNOVATIVE FEATURESBUILDING CONCEPT AND PROJECT OVERVIEWIDT Biologika 2015 FOYA Award Facility Integration Building conceptuniquestrategydesignedforefficiencyVentilation LevelProduction LevelService LevelfficesThree physical levelsStrict horizontal division of the service areas and serviced areasShortest supply and disposal routesIDT Biologika 2015 FOYA Awar

d Facility Integration Integrated equi
d Facility Integration Integrated equipment suite represents significant contributions in operational excellenceThree isolator segments for high flexibility and fast product changesEfficient product change overIndustry leading aseptic isolator technologyHigh level safety eliminates risk of cross contamination IDT Biologika 2015 FOYA Award Facility Integration

Project overviewambitiousprojecttimeline
Project overviewambitiousprojecttimelinesExcellence in project executionRegular meetings with joint project team/experts (operating company, quality assurance, general contractor, architect and technical planning)Monthly reportsBudget control2014 (Jul)GMP inspection (German authorities)2014 (Sep)Qualification2014 (Oct)Manufacturing Authorisation2011 (May)Tentative

start of construction2011 (Q3)Regulatory
start of construction2011 (Q3)Regulatory advice (FDA)2013 (Oct)Technical CompletionIDT Biologika 2015 FOYA Award Facility Integration Choice for “bestclass” and “innovative” suppliersThe architect/designerfor the project was HeeneProebst, recognized for their integrated planning processes with the early inclusion of building technology, struc

tural and process planning, for the crea
tural and process planning, for the creation of futureproof and flexible production structures, maximizing benefit for the client. IDT Biologika 2015 FOYA Award Facility Integration Choice for “bestclass” and “innovative” suppliers (cont.)Process engineering was provided by BidecoBioPharmasysteme, specialists in the fields of biotechnology and

pharmaceutical processing, with experts
pharmaceutical processing, with experts in validation and GMPIDT chose Groninger& Co. GmbH for its bestclass, pharmaceutical vial filling technologies.IDT chose HOF SonderanlagenbauGmbH, known for statetheart freezedrying componentsfeaturing innovative loading and unloading systems. For isolator technology, SKAN AG, the largest supplier and technology leader for as

eptic isolators in the pharmaceutical in
eptic isolators in the pharmaceutical industry, was chosen for their industry leading knowhow, quality and experience in qualification of aseptic isolators. IDT Biologika 2015 FOYA Award Facility Integration 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 increasin
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 biopharmac
for the world’s leading biopharmaceutical industriesIDT Biologika 2015 FOYA Award Facility Integration FOYA Judges Panel ConclusionThe highly automated manufacturing facility for filling and freezedrying 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 s
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 IDT BIOLOGIKACategory Winner for Facility IntegrationIDT Biologika 2015 FOYA Award Facility Integration Advance Vaccines and BiotherapeuticProject