Download - THE COMPANY
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THE COMPANY
Founded 1988 in Linz, Austria; privately owned
Leading supplier of high quality cell culture products
Third largest FBS processor world-wide
Products manufactured in Europe, North America and Australia
Present in 50+ countries through own operations, exclusive distributors and OEM customers
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NOW AND THEN
7 years average sales growth p.a.: >35%
2005 sales (b): US$ 35 million
2006 sales (e): US$ 50 million
~120 people employed
99% of all products sold outside Austria
THE „OLD“ GROUP
over 40 Distributorsworld-wide
PAA Austria, PaschingManufacturing
Distributor Sales
PAA Germany, CölbeSales in Germany
Marketing world-wide
PAA France, ParisSales in France
PAA UK, YeovilSales in UK
THE „NEW“ GROUP
PAA EuropeA, GER, F, UK
Manufacturing & Marketing
PAA North AmericaToronto
Manufacturing
PAA AustraliaBrisbane
Manufacturing
Terracell
Cansera
PAA
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PAA Laboratories: The Group
Board of Directors:Rainer C. BurianAndreas MladekHarry BrackRainer Waldmann
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THE CUSTOMERS
Cell culture academic research & industry, clinics and hospitals
Cell culture departments of the molecular biology research
Diagnostic industry
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THE PRODUCTS
All types of animal sera
Human sera
Basal and special liquid media
Components and additives
Custom made fillings and formulations
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ANIMAL SERUM
Foetal Bovine Serum (FBS) Regular grade FBS FBS „Gold“ “EMEA tested” FBS
Bovine derived Serum Newborn Calf Calf Adult Bovine
Other Animal Serum all species available
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FOETAL BOVINE SERUM
Third largest processor world-wide
Largest processor in Europe
Raw material from USDA and EU accepted origins
Extensive documentation enables full traceability: PAA batch release protocol EDQM certificate of suitability PAA Quality Manual
Wide variety of origins, specifications and treatments available
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HUMAN SERUM
many different grades available
sterile filtered off the clot for cell culture use
converted grade for diagnostic application
stringent testing according to prevailing FDA regulations
full documentation on donors and collection procedures on file
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LIQUID MEDIA
Standard basal media Cell-type specific media for the academic market:
“Quantum” serum-free media, cell-type specific „SerEx!” Serum Additive for serum-free culture
Cell-type specific media for the industry: „Express“ ADC-free media
MDCK Express for cultivation of MDCK cells Vero Express HEK 293 Express CHO Express BHK Express
Serum Substitute „Lipumin™“
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COMPONENTS & ADDITIVES Detachment and attachment factors:
native and recombinant Trypsin, Collagenase
Accutase™, AccuMax™
human Fibronectin
Antibiotics and selection-antibiotics for transfection G-418 sulphate
Hygromycin, Blasticidin & Other
Mycoplasma specific Antibiotic „Mycokill“
Hybridoma Cloning Factor
Buffers, vitamins, salt solutions
Bovine serum albumin and bovine serum fractions
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Filling of a wide variety of substances under cGMP conditions
All products manufactured according to customer's requirements
Products can be filled in PET bottles or pharmaceutical-grade plastic bags
Different lock and coupling systems offered
CUSTOMIZED FILLINGS
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REFERENCES
Baxter, Austria
Boehringer Ingelheim, Austria
Roche Diagnostics, Germany
Merial, France
Aventis, France
Bio-Mérieux, France
Novartis, UK
Astra-Zeneca, UK
Bayer, Germany
Japan Tobacco, Japan
Kirin Breweries, Japan
Olympus Diagnostics, Ireland
Glaxo Smith Kline ( UK + Belgium)
Serum Institute of Indiaetc.
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5.000 m² (50,000 sqft) under roof
Completion in October 2003
Investment US$ 15 million
GENERAL INFORMATION
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Compliance with FDA, EMEA and EP guidelines
cGMP pharmaceutical license granted by Ministry
Validation according to ICH Q7A guideline “manufacturing API’s”
THE STANDARD
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Lab
elin
g
Pac
kin
g
THE HVAC SYSTEM
Pool 1Fill 1
Fill 2
Wash Dry
We
igh
Spare
Spare
Chrom.UF
Prod.Storage
Prod.Storage
+ 4°C
Empty bottles
Blank labels
Archive
WaterBaths
Thaw
Ch
emic
als
Pack-aging
Pool 2P
re-
pa
rati
on
Four different air zones from controlled into D into C into A
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WFI in 6,000 L tank according to FDA standard
Clean-in-Place (CIP) and Steam-in-Place (SIP) System for all fill lines
WFI, CIP & SIP
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12.000 m³ room temperature, cooler and freezer areas
Raw material sepa-rated from final frozen products
THE WAREHOUSE
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Two 2,500 L and one 3,000 L pooling tank in place
Filling done by 2.500 L „true pool“ lots
POOLING
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Three separate fill lines (one from it fully automated)
Max. fill capacity 15,000 L / day
Media and sera fills at separate lines
STERILE FILL
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Full-automatic bar-coding, labeling, sleeving system
LABELING
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One full-automatic packing line for liquid media
PACKING
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Certificate of Analysis according to EP and 9CFR
Full “EMEA testing” for Australian FBS
QUALITY CONTROL
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Material filled in validated NALGE or PET-Power bottles of different sizes
THE END-PRODUCT
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SHIPPING
Products shipped to >5,000 customers in >50 countries
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“Upper Austria’s Leading Company” 2003
“Austria’s Leading Mid-Sized Company” 2004
“Golden Pegasus” Prize Winner 2004