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THE COMPANY

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

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THE COMPANY

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  1. 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

  2. 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

  3. over 40 Distributors world-wide THE „OLD“ GROUP PAA Austria, Pasching Manufacturing Distributor Sales PAA France, Paris Sales in France PAA Germany, Cölbe Sales in Germany Marketing world-wide PAA UK, Yeovil Sales in UK

  4. THE „NEW“ GROUP PAA PAA North America Toronto Manufacturing PAA Europe A, GER, F, UK Manufacturing & Marketing Cansera Terracell PAA Australia Brisbane Manufacturing

  5. THE CUSTOMERS • Cell culture academic research & industry, clinics and hospitals • Cell culture departments of the molecular biology research • Diagnostic industry

  6. THE PRODUCTS • All types of animal sera • Human sera • Basal and special liquid media • Components and additives • Custom made fillings and formulations

  7. 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 NEW!

  8. 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

  9. 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

  10. 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™“ LIQUID MEDIA NEW! NEW!

  11. 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 COMPONENTS & ADDITIVES NEW! NEW!

  12. CUSTOMIZED FILLINGS • 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

  13. 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.

  14. The New Factory

  15. GENERAL INFORMATION • 5.000 m² (50,000 sqft) under roof • Completion in October 2003 • Investment US$ 15 million

  16. THE STANDARD • Compliance with FDA, EMEA and EP guidelines • cGMP pharmaceutical license granted by Ministry • Validation according to ICH Q7A guideline “manufacturing API’s”

  17. Labeling Packing

  18. Blank labels Spare Thaw Empty bottles Chemicals Archive Water Baths Spare Pack- aging Dry Wash Pool 1 Fill 1 Pre- paration Pool 2 Fill 2 Prod. Storage Prod. Storage + 4°C Chrom. UF Weigh THE HVAC SYSTEM Four different air zones from controlled into D into C into A

  19. WFI, CIP & SIP • WFI in 6,000 L tank according to FDA standard • Clean-in-Place (CIP) and Steam-in-Place (SIP) System for all fill lines

  20. THE WAREHOUSE • 12.000 m³ room temperature, cooler and freezer areas • Raw material sepa-rated from final frozen products

  21. POOLING • Two 2,500 L and one 3,000 L pooling tank in place • Filling done by 2.500 L „true pool“ lots

  22. STERILE FILL • Three separate fill lines (one from it fully automated) • Max. fill capacity 15,000 L / day • Media and sera fills at separate lines

  23. LABELING • Full-automatic bar-coding, labeling, sleeving system

  24. PACKING • One full-automatic packing line for liquid media

  25. QUALITY CONTROL • Certificate of Analysis according to EP and 9CFR • Full “EMEA testing” for Australian FBS

  26. THE END-PRODUCT • Material filled in validated NALGE or PET-Power bottles of different sizes

  27. SHIPPING • Products shipped to >5,000 customers in >50 countries

  28. “Upper Austria’s Leading Company” 2003 “Austria’s Leading Mid-Sized Company” 2004 “Golden Pegasus” Prize Winner 2004

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