Microsoft PowerPoint - Folien_Buecheler_Internet.ppt - Boehringer ...
Microsoft PowerPoint - Folien_Buecheler_Internet.ppt - Boehringer ...
Microsoft PowerPoint - Folien_Buecheler_Internet.ppt - Boehringer ...
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Please enter title of conference,<br />
maximum 2 lines, optimum type size 28 pt<br />
Please enter title of presentation,<br />
maximum 4 lines, optimum type size 32 pt<br />
Biopharmaceuticals<br />
Site Biberach<br />
Dr. Uwe Bücheler<br />
Senior Vice President Biopharmaceuticals<br />
<strong>Boehringer</strong> Ingelheim Deutschland GmbH
<strong>Boehringer</strong> Ingelheim Germany<br />
Sites in Ingelheim, Biberach and Dortmund<br />
Ingelheim<br />
Administration<br />
Prescription Medicines<br />
Consumer Health Care<br />
Animal Health<br />
Manufacturing Pharma<br />
Chemicals<br />
Development<br />
Medicine<br />
Dortmund<br />
<strong>Boehringer</strong> Ingelheim<br />
microParts GmbH<br />
Special microsystem technology<br />
(eg respimat ® Soft Mist Inhaler)<br />
Biberach<br />
Research and development<br />
Medicine<br />
Biopharmaceuticals<br />
Administration
H84<br />
Multiproduct Cell Culture Facilities<br />
Start up 1985 (2007)<br />
Fermentation<br />
capacity 6 x 15.000 l<br />
G104<br />
2004<br />
6 x 15.000 l<br />
� largest cell culture Production facility in Europe and<br />
one of the largest worldwide
“ Cells“ for manufacturing of Biopharmaceuticals<br />
Microorganism´s<br />
e.g. Bacteria<br />
(0,3 - 1 μm)<br />
Small proteins (small complexity)<br />
- Peptide<br />
- Plasmid DNA<br />
Biopharmaceuticals<br />
Mammalian cells<br />
e.g. Hamster cells<br />
(10 - 100 μm)<br />
Complex proteins<br />
- Enzyme<br />
- Monoclonal Antibody
Manufacturing facility „Cell“<br />
Polysomen<br />
Mitochondrium<br />
Endoplasmatisches<br />
Reticulum<br />
Vesikel<br />
Zellkern<br />
Pore<br />
Manufacturing<br />
Powerstation<br />
Infrastructure<br />
Storage vessels<br />
Management<br />
Site gate
Upstream Development<br />
Development Phases<br />
Amp<br />
f1 ori<br />
SV40 ori<br />
ColE1 ori<br />
Selection marker<br />
Molecular<br />
Biology<br />
Enhancer<br />
BI prom.<br />
Terminator<br />
Number of Clones<br />
200<br />
BI HEX BI vector VECTOR<br />
150<br />
6175 bp<br />
6175 bp 100<br />
find this cell!<br />
50<br />
0<br />
Cell Line<br />
Development &<br />
Cell Banking<br />
0 1 2 3 4 5 6 7 8 9 10 11 12<br />
Productivity<br />
Process<br />
Development<br />
Process<br />
Transfer &<br />
2000l GMP train<br />
Process<br />
Robustness &<br />
Ranges
Master Cellbank (MCB)<br />
The “Master Cell Bank”<br />
is „unique“<br />
for each product and<br />
defines the product
Biosimilars are not Generics!<br />
Are we identical – or just similar?
GMP Compliance<br />
Process Development and Commercial Manufacturing<br />
of Cell Culture Products (Biberach, Germany)<br />
Engineering<br />
Documentation<br />
Drug Substance Drug Product<br />
Production<br />
Downstream<br />
Development<br />
Registration<br />
Molecular<br />
Biology<br />
Logistics Project Management Controlling Business Development<br />
Upstream<br />
Development<br />
Analytical Sciences<br />
Production<br />
Packaging /<br />
Labelling<br />
Quality Control<br />
Formulation<br />
Development<br />
Pharmaceutical<br />
Development<br />
Microbiology / Virology
Operation Process Chain<br />
Biotech Operation<br />
fermentation<br />
6 – 8<br />
weeks<br />
hours<br />
Down<br />
stream<br />
processing<br />
1-3<br />
days<br />
Days /<br />
weeks<br />
Formulation<br />
1<br />
day<br />
Hours /<br />
days<br />
Biopharma Operation<br />
Aseptic<br />
processing<br />
Protein = API Final product<br />
API <strong>Boehringer</strong> Ingelheim Austria, Vienna<br />
1-4<br />
days<br />
100%<br />
visual<br />
inspection<br />
1-4<br />
days
Project: Modernization building H84 (2005-<br />
2007)<br />
before after<br />
Invest Volume: 80 Mio. Euro
Innovation in Application Systems for<br />
Parenterals<br />
Cartridges/<br />
PENs
Syringe Line EU/FDA Licensure 2007<br />
(Invest Volume: 4,9 Mio. Euro)
Biopharmaceuticals for <strong>Boehringer</strong> Ingelheim<br />
Heart infarction, lung embolism, stroke Heart infarction<br />
Immukin®<br />
chronic granulomatosis<br />
Beromun ®<br />
sarcom
Manufacturing partnership for products on the<br />
market<br />
ENBREL ®<br />
Rheumatoid Arthritis ERBITUX ®<br />
Colon cancer<br />
BETAFERON ®<br />
Multiple Sclerosis<br />
SYNAGIS ®<br />
RSV Virus<br />
BEXXAR® CAMPATH-1H ®<br />
Non-Hodgkin`s Lymphoma<br />
Chron. Lyph. Leukemia
Outlook<br />
Licensure of 3-4 new Biopharmaceuticals manufactured at<br />
<strong>Boehringer</strong> Ingelheim in Biberach is expected<br />
- Oncology<br />
- Infectious diseases<br />
- Immunology
Please enter title of conference,<br />
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Please enter title of presentation,<br />
maximum 4 lines, optimum type size 32 pt<br />
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