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Published byMarjorie Neal Modified over 9 years ago
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2 THE COMPANY è Founded 1988 in Linz, Austria; privately owned è Leading supplier of high quality cell culture products è Third largest FBS processor world-wide è Products manufactured in Europe, North America and Australia è Present in 50+ countries through own operations, exclusive distributors and OEM customers
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3 NOW AND THEN è 7 years average sales growth p.a.: >35% è 2005 sales (b): US$ 35 million è 2006 sales (e): US$ 50 million è ~120 people employed è 99% of all products sold outside Austria
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THE „OLD“ GROUP over 40 Distributors world-wide PAA Austria, Pasching Manufacturing Distributor Sales PAA Germany, Cölbe Sales in Germany Marketing world-wide PAA France, Paris Sales in France PAA UK, Yeovil Sales in UK
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THE „NEW“ GROUP PAA Europe A, GER, F, UK Manufacturing & Marketing PAA North America Toronto Manufacturing PAA Australia Brisbane Manufacturing Terracell Cansera PAA
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7 THE CUSTOMERS è Cell culture academic research & industry, clinics and hospitals è Cell culture departments of the molecular biology research è Diagnostic industry
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8 THE PRODUCTS è All types of animal sera è Human sera è Basal and special liquid media è Components and additives è Custom made fillings and formulations
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9 ANIMAL SERUM è Foetal Bovine Serum (FBS) n Regular grade FBS n FBS „Gold“ n “EMEA tested” FBS è Bovine derived Serum n Newborn Calf n Calf n Adult Bovine è Other Animal Serum n all species available
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10 FOETAL BOVINE SERUM è Third largest processor world-wide è Largest processor in Europe è Raw material from USDA and EU accepted origins è Extensive documentation enables full traceability: n PAA batch release protocol n EDQM certificate of suitability n PAA Quality Manual è Wide variety of origins, specifications and treatments available
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11 HUMAN SERUM è many different grades available n sterile filtered off the clot for cell culture use n converted grade for diagnostic application è stringent testing according to prevailing FDA regulations è full documentation on donors and collection procedures on file
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12 LIQUID MEDIA è Standard basal media è Cell-type specific media for the academic market: n “Quantum” serum-free media, cell-type specific n „SerEx!” Serum Additive for serum-free culture è Cell-type specific media for the industry: n „Express“ ADC-free media o MDCK Express for cultivation of MDCK cells o Vero Express o HEK 293 Express o CHO Express o BHK Express n Serum Substitute „Lipumin™“
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13 COMPONENTS & ADDITIVES è Detachment and attachment factors: n native and recombinant Trypsin, Collagenase n Accutase™, AccuMax™ n human Fibronectin è Antibiotics and selection-antibiotics for transfection n G-418 sulphate n Hygromycin, Blasticidin & Other n Mycoplasma specific Antibiotic „Mycokill“ n Hybridoma Cloning Factor è Buffers, vitamins, salt solutions è Bovine serum albumin and bovine serum fractions
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14 è Filling of a wide variety of substances under cGMP conditions è All products manufactured according to customer's requirements è Products can be filled in PET bottles or pharmaceutical- grade plastic bags è Different lock and coupling systems offered CUSTOMIZED FILLINGS
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15 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 India etc.
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17 5.000 m² (50,000 sqft) under roof Completion in October 2003 Investment US$ 15 million GENERAL INFORMATION
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18 è Compliance with FDA, EMEA and EP guidelines è cGMP pharmaceutical license granted by Ministry è Validation according to ICH Q7A guideline “manufacturing API’s” THE STANDARD
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19 LabelingPacking
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THE HVAC SYSTEM Pool 1 Fill 1 Fill 2 Wash Dry Weigh Spare Chrom. UF Prod. Storage Prod. Storage + 4°C Empty bottles Blank labels Archive Water Baths Thaw Chemicals Pack- aging Pool 2 Pre- paration Four different air zones from controlled into D into C into A
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21 è WFI in 6,000 L tank according to FDA standard è Clean-in-Place (CIP) and Steam-in-Place (SIP) System for all fill lines WFI, CIP & SIP
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22 è 12.000 m³ room temperature, cooler and freezer areas è Raw material sepa- rated from final frozen products THE WAREHOUSE
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23 è Two 2,500 L and one 3,000 L pooling tank in place è Filling done by 2.500 L „true pool“ lots POOLING
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24 è Three separate fill lines (one from it fully automated) è Max. fill capacity 15,000 L / day è Media and sera fills at separate lines STERILE FILL
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25 è Full-automatic bar- coding, labeling, sleeving system LABELING
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26 è One full-automatic packing line for liquid media PACKING
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27 è Certificate of Analysis according to EP and 9CFR è Full “EMEA testing” for Australian FBS QUALITY CONTROL
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28 è Material filled in validated NALGE or PET-Power bottles of different sizes THE END-PRODUCT
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29 SHIPPING è Products shipped to >5,000 customers in >50 countries
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30 “Upper Austria’s Leading Company” 2003 “Austria’s Leading Mid-Sized Company” 2004 “Golden Pegasus” Prize Winner 2004
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