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Page 1: 1 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.

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Page 2: 1 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.

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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

Page 3: 1 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.

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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

Page 4: 1 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.

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

Page 5: 1 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.

THE „NEW“ GROUP

PAA EuropeA, GER, F, UK

Manufacturing & Marketing

PAA North AmericaToronto

Manufacturing

PAA AustraliaBrisbane

Manufacturing

Terracell

Cansera

PAA

Page 6: 1 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.

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PAA Laboratories: The Group

Board of Directors:Rainer C. BurianAndreas MladekHarry BrackRainer Waldmann

Page 7: 1 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.

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THE CUSTOMERS

Cell culture academic research & industry, clinics and hospitals

Cell culture departments of the molecular biology research

Diagnostic industry

Page 8: 1 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.

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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

Page 9: 1 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.

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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

Page 10: 1 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.

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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

Page 11: 1 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.

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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

Page 12: 1 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.

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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™“

Page 13: 1 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.

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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

Page 14: 1 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.

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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

Page 15: 1 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.

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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.

Page 16: 1 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.
Page 17: 1 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.

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5.000 m² (50,000 sqft) under roof

Completion in October 2003

Investment US$ 15 million

GENERAL INFORMATION

Page 18: 1 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.

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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

Page 19: 1 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.

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Lab

elin

g

Pac

kin

g

Page 20: 1 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.

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

Page 21: 1 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.

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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

Page 22: 1 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.

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12.000 m³ room temperature, cooler and freezer areas

Raw material sepa-rated from final frozen products

THE WAREHOUSE

Page 23: 1 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.

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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

Page 24: 1 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.

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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

Page 25: 1 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.

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Full-automatic bar-coding, labeling, sleeving system

LABELING

Page 26: 1 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.

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One full-automatic packing line for liquid media

PACKING

Page 27: 1 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.

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Certificate of Analysis according to EP and 9CFR

Full “EMEA testing” for Australian FBS

QUALITY CONTROL

Page 28: 1 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.

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Material filled in validated NALGE or PET-Power bottles of different sizes

THE END-PRODUCT

Page 29: 1 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.

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SHIPPING

Products shipped to >5,000 customers in >50 countries

Page 30: 1 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.

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“Upper Austria’s Leading Company” 2003

“Austria’s Leading Mid-Sized Company” 2004

“Golden Pegasus” Prize Winner 2004


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