Biopharmaceuticals Site Biberach

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maximumBiopharmaceuticals
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Site Biberach
Dr. Uwe Bücheler
Senior Vice President Biopharmaceuticals
Boehringer Ingelheim Deutschland GmbH
Boehringer Ingelheim Germany
Sites in Ingelheim, Biberach and Dortmund
Dortmund
Boehringer Ingelheim
microParts GmbH
Special microsystem technology
(eg respimat ® Soft Mist Inhaler)
Ingelheim
Administration
Prescription Medicines
Consumer Health Care
Animal Health
Manufacturing Pharma
Chemicals
Development
Medicine
Biberach
Research and development
Medicine
Biopharmaceuticals
Administration
Multiproduct Cell Culture Facilities
H84
G104
Start up
1985 (2007)
2004
Fermentation
capacity
6 x 15.000 l
6 x 15.000 l
Æ
largest cell culture Production facility in Europe and
one of the largest worldwide
“ Cells“ for manufacturing of Biopharmaceuticals
Mammalian cells
e.g. Hamster cells
(10 - 100 μm)
Microorganism´s
e.g. Bacteria
(0,3 - 1 μm)
Biopharmaceuticals
Small proteins (small complexity)
Peptide
Plasmid DNA
Complex proteins
Enzyme
Monoclonal Antibody
Manufacturing facility „Cell“
Polysomen
Manufacturing
Mitochondrium
Powerstation
Endoplasmatisches
Reticulum
Infrastructure
Vesikel
Storage vessels
Zellkern
Management
Pore
Site gate
Upstream Development
Development Phases
BI prom.
Terminator
Amp
BI vector
BI HEX
VECTOR
6175 bp
6175 bp
f1 ori
SV40 ori
Selection marker
Number of Clones
Enhancer
ColE1 ori
200
150
100
find this cell!
50
0 0 1 2 3 4 5 6 7 8 9 10 11 12
Productivity
Molecular
Biology
Cell Line
Development &
Cell Banking
Process
Development
Process
Transfer &
2000l GMP train
Process
Robustness &
Ranges
Master Cellbank (MCB)
The “Master Cell Bank”
is „unique“
for each product and
defines the product
Biosimilars are not Generics!
Are we identical – or just similar?
Process Development and Commercial Manufacturing
of Cell Culture Products (Biberach, Germany)
e
in
g
En
g
in
r
e
ion
t
a
t
men
u
c
Do
Logistics
Project Managem
Drug Substance
ent
Contr
olling
Bu
Drug Product
Production
Molecular
Biology
Production
Downstream
Development
Upstream
Development
Packaging /
Labelling
lop
m
en
t
Pharmaceutical
Development
ia
pl
om
PC
GM
e
nc
Analytical Sciences
ntrol
o
C
y
t
i
Q u al
De
ve
Formulation
Development
M
Reg
istra
tion
sin
es
s
log
o
i
ob
icr
V
y/
ir
gy
o
l
o
Operation Process Chain
Biopharma Operation
Biotech Operation
fermentation
hours
Down
stream
processing
Days /
weeks
Formulation
Protein = API
Hours /
days
Aseptic
processing
100%
visual
inspection
Final product
API Boehringer Ingelheim Austria, Vienna
6–8
weeks
1-3
days
1
day
1-4
days
1-4
days
Project: Modernization building H84 (20052007)
before
after
Invest Volume: 80 Mio. Euro
Innovation in Application Systems for
Parenterals
Cartridges/
PENs
Syringe Line EU/FDA Licensure 2007
(Invest Volume: 4,9 Mio. Euro)
Biopharmaceuticals for Boehringer Ingelheim
Heart infarction, lung embolism, stroke
Immukin®
chronic granulomatosis
Beromun®
sarcom
Heart infarction
Manufacturing partnership for products on the
market
ENBREL ®
Rheumatoid Arthritis
ERBITUX ®
Colon cancer
BETAFERON ®
Multiple Sclerosis
BEXXAR®
Non-Hodgkin`s Lymphoma
SYNAGIS ®
RSV Virus
CAMPATH-1H ®
Chron. Lyph. Leukemia
Outlook
Licensure of 3-4 new Biopharmaceuticals manufactured at
Boehringer Ingelheim in Biberach is expected
- Oncology
- Infectious diseases
- Immunology
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