Safc Biosciences - Quick Custom Formulations
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- Pages: 6
1736 69 imMEDIAte Advan Bro 6pp
13/2/07
12:14
Page 4
Process Development
It’s all about speed Customized formulations for process development
www.safcbiosciences.com
Member of the Sigma-Aldrich Group
1736 69 imMEDIAte Advan Bro 6pp
13/2/07
12:14
Page 5
Gain the imMEDIAte ADVANTAGE™ • Quick-turnaround • Customized non-cGMP formulations in small volumes • Designed for industrial-focused process development customers
We offer the media formulations you want, when you want them, to develop and scale-up your commercial cell culture processes. Responsive to your timelines
Flexible
• Orders manufactured within 10 business days or less
Move more quickly through the drug development pipeline
• Multiple manufacturing locations throughout the United States and Europe ensure global responsiveness
• Small volume custom liquid and powder reagents
• Assists with engineering runs, technical transfer, toxicology runs, developing small-scale models and the scale-up process
Global imMEDIAte ADVANTAGE™ lead times 14 Days from order to complete manufacture
• Ideal for use in media and feed selection and optimization
12
Seamless scale-up
10
• More than 95% of all components are used in cGMP manufacturing, have been QA released and meet stringent Raw Material Specifications
8 6 4 2 0 Jul-Sep 2004
Oct-Dec 2004
Jan-Mar 2005
Apr-Jun 2005
Jul-Sep 2005
Oct-Dec 2005
Jan-Mar 2006
Apr-Jun 2006
• Batch records for manufacturing processes and finished products utilize the same business processing system as cGMP manufacturing • Certificates of Compliance are available upon request
Projects scaled-up from imMEDIAte ADVANTAGE™ to cGMP production 25
Standard Testing Number of projects
20
pH 15
Osmolality 10
Physical Appearance 5
0 Jul -Sep 2003
Oct -Dec 2003
Jan -Mar 2004
Apr -Jun 2004
Jul -Sep 2004
Oct -Dec 2004
Jan -Mar 2005
Apr -Jun 2005
Jul Oct -Sep -Dec 2005 2005
Jan Apr -Mar -Jun 2006 2006
Abbreviated Sterility (for liquid formulations) Solubility (for dry powder formulations)
1736 69 imMEDIAte Advan Bro 6pp
13/2/07
12:13
Page 2
Responsive Expertise SAFC Biosciences is the world’s leading supplier of cell culture reagents to producers of marketed biological products. We are committed to supplying high-quality critical raw materials and specialized cell culture products and services to the global health care industry. By providing the broadest range of highly customized products and services possible to cell culture-based manufacturing companies we demonstrate our commitment to being responsive experts.
SAFC Biosciences’ cycle of support
Customer project timeline met
Nutrient consumption & formation (Testing Services)
Small scale custom manufacture: imMEDIAte ADVANTAGE™
Custom product stability testing (Testing Services)
Scale-up support to GMP: imMEDIAte ADVANTAGE™
1736 69 imMEDIAte Advan Bro 6pp
13/2/07
12:14
Page 6
Concentrates, feeds and supplements • SAFC Biosciences has extensive experience manufacturing concentrates, feeds and supplements to match your complex manufacturing systems • Feasibility is formulation-dependent and is verified prior to manufacture • We routinely provide customers with vitamin, trace element, amino acid and hydrolysate feeds • Customization of your concentrates, feeds and supplements is available Testing services Personalized service • imMEDIAte ADVANTAGE™ offers you direct access to dedicated staff with extensive expertise, experience and knowledge in formulation chemistry to support the completion of your milestones • SAFC Biosciences provides a single point of contact that follows the processing of your order from receipt to your doorstep, allowing you to focus on your projects
This specialized service consists of a battery of tests for nutrient analysis designed to provide valuable information for cell and media optimization studies. Testing to support stability studies is also available. We offer: Item No.
Tests to Support Nutrient Analysis
88103
Amino Acid Analysis (HPLC)
88102
Cholesterol
88202
Glucose
88101
Lipids/Fatty Acids
88100
Vitamin Analysis (HPLC)
Item No.
Tests to Support Stability
88210
Appearance
88208
Bioburden
88204
Endotoxin (LAL)
88212
Growth Promotion (MTT)
88224
Moisture
88206
Osmolality
88213
Osmolality (without sodium bicarbonate)
88207
pH
88214
pH (without sodium bicarbonate)
1736 69 imMEDIAte Advan Bro 6pp
13/2/07
12:14
Page 7
Placing your order
To take advantage of SAFC Biosciences’ responsive expertise in helping you meet your process development milestones or request pricing, contact your Business Development Manager or Customer Service.
Format
Lot Size
Packaging Options
Fill Capacity Options
Liquid media
1 L to 50 L
Plastic bottles
50 mL to 2000 mL
Liquid media
1 L to 200 L
Plastic bottles
500 mL to 2000 mL
Liquid media
5 L to 200 L
Media bags (10 L stock bag & 20 L stock bag)
5 L to 20 L
Dry powder media
500 g to 5 kg
Plastic containers
By volume up to 100 L (dependent on g/L weight of product)
Dry powder media
500 g to 5 kg
Plastic containers
By weight up to 5 kg
Please have the following information available when requesting imMEDIAte ADVANTAGE™ services
Item No. (if previously ordered from SAFC Biosciences)
Name
Item Description
Position
Company Name Liquid
Lot Size
Dry Powder
Address
Preferred Package Size
Formulation Tel:
Fax:
E-mail:
1736 69 imMEDIAte Advan Bro 6pp
13/2/07
12:14
Page 3
Contact us United States SAFC Biosciences, Inc. 13804 W. 107th Street Lenexa, Kansas 66215 USA Tel: +1 913-469-5580 Toll Free – USA: 1 800-255-6032 Fax: +1 913-469-5584 E-mail: [email protected]
Europe SAFC Biosciences Ltd. Smeaton Road, West Portway Andover, Hampshire SP10 3LF UNITED KINGDOM Tel: +44 (0)1264-333311 Fax: +44 (0)1264-332412 E-mail: [email protected]
Asia Pacific SAFC Biosciences Pty. Ltd. 18-20 Export Drive Brooklyn, Victoria 3025 AUSTRALIA Tel: +61 (0)3-9362-4500 Toll Free – AUS: 1 800-200-404 Fax: +61 (0)3-9315-1656 E-mail: [email protected]
imMEDIAte ADVANTAGE™ is a trademark of SAFC Biosciences, Inc. © 2006 SAFC Biosciences, Inc. Issued December 2006
www.safcbiosciences.com
G052
Member of the Sigma-Aldrich Group
13/2/07
12:14
Page 4
Process Development
It’s all about speed Customized formulations for process development
www.safcbiosciences.com
Member of the Sigma-Aldrich Group
1736 69 imMEDIAte Advan Bro 6pp
13/2/07
12:14
Page 5
Gain the imMEDIAte ADVANTAGE™ • Quick-turnaround • Customized non-cGMP formulations in small volumes • Designed for industrial-focused process development customers
We offer the media formulations you want, when you want them, to develop and scale-up your commercial cell culture processes. Responsive to your timelines
Flexible
• Orders manufactured within 10 business days or less
Move more quickly through the drug development pipeline
• Multiple manufacturing locations throughout the United States and Europe ensure global responsiveness
• Small volume custom liquid and powder reagents
• Assists with engineering runs, technical transfer, toxicology runs, developing small-scale models and the scale-up process
Global imMEDIAte ADVANTAGE™ lead times 14 Days from order to complete manufacture
• Ideal for use in media and feed selection and optimization
12
Seamless scale-up
10
• More than 95% of all components are used in cGMP manufacturing, have been QA released and meet stringent Raw Material Specifications
8 6 4 2 0 Jul-Sep 2004
Oct-Dec 2004
Jan-Mar 2005
Apr-Jun 2005
Jul-Sep 2005
Oct-Dec 2005
Jan-Mar 2006
Apr-Jun 2006
• Batch records for manufacturing processes and finished products utilize the same business processing system as cGMP manufacturing • Certificates of Compliance are available upon request
Projects scaled-up from imMEDIAte ADVANTAGE™ to cGMP production 25
Standard Testing Number of projects
20
pH 15
Osmolality 10
Physical Appearance 5
0 Jul -Sep 2003
Oct -Dec 2003
Jan -Mar 2004
Apr -Jun 2004
Jul -Sep 2004
Oct -Dec 2004
Jan -Mar 2005
Apr -Jun 2005
Jul Oct -Sep -Dec 2005 2005
Jan Apr -Mar -Jun 2006 2006
Abbreviated Sterility (for liquid formulations) Solubility (for dry powder formulations)
1736 69 imMEDIAte Advan Bro 6pp
13/2/07
12:13
Page 2
Responsive Expertise SAFC Biosciences is the world’s leading supplier of cell culture reagents to producers of marketed biological products. We are committed to supplying high-quality critical raw materials and specialized cell culture products and services to the global health care industry. By providing the broadest range of highly customized products and services possible to cell culture-based manufacturing companies we demonstrate our commitment to being responsive experts.
SAFC Biosciences’ cycle of support
Customer project timeline met
Nutrient consumption & formation (Testing Services)
Small scale custom manufacture: imMEDIAte ADVANTAGE™
Custom product stability testing (Testing Services)
Scale-up support to GMP: imMEDIAte ADVANTAGE™
1736 69 imMEDIAte Advan Bro 6pp
13/2/07
12:14
Page 6
Concentrates, feeds and supplements • SAFC Biosciences has extensive experience manufacturing concentrates, feeds and supplements to match your complex manufacturing systems • Feasibility is formulation-dependent and is verified prior to manufacture • We routinely provide customers with vitamin, trace element, amino acid and hydrolysate feeds • Customization of your concentrates, feeds and supplements is available Testing services Personalized service • imMEDIAte ADVANTAGE™ offers you direct access to dedicated staff with extensive expertise, experience and knowledge in formulation chemistry to support the completion of your milestones • SAFC Biosciences provides a single point of contact that follows the processing of your order from receipt to your doorstep, allowing you to focus on your projects
This specialized service consists of a battery of tests for nutrient analysis designed to provide valuable information for cell and media optimization studies. Testing to support stability studies is also available. We offer: Item No.
Tests to Support Nutrient Analysis
88103
Amino Acid Analysis (HPLC)
88102
Cholesterol
88202
Glucose
88101
Lipids/Fatty Acids
88100
Vitamin Analysis (HPLC)
Item No.
Tests to Support Stability
88210
Appearance
88208
Bioburden
88204
Endotoxin (LAL)
88212
Growth Promotion (MTT)
88224
Moisture
88206
Osmolality
88213
Osmolality (without sodium bicarbonate)
88207
pH
88214
pH (without sodium bicarbonate)
1736 69 imMEDIAte Advan Bro 6pp
13/2/07
12:14
Page 7
Placing your order
To take advantage of SAFC Biosciences’ responsive expertise in helping you meet your process development milestones or request pricing, contact your Business Development Manager or Customer Service.
Format
Lot Size
Packaging Options
Fill Capacity Options
Liquid media
1 L to 50 L
Plastic bottles
50 mL to 2000 mL
Liquid media
1 L to 200 L
Plastic bottles
500 mL to 2000 mL
Liquid media
5 L to 200 L
Media bags (10 L stock bag & 20 L stock bag)
5 L to 20 L
Dry powder media
500 g to 5 kg
Plastic containers
By volume up to 100 L (dependent on g/L weight of product)
Dry powder media
500 g to 5 kg
Plastic containers
By weight up to 5 kg
Please have the following information available when requesting imMEDIAte ADVANTAGE™ services
Item No. (if previously ordered from SAFC Biosciences)
Name
Item Description
Position
Company Name Liquid
Lot Size
Dry Powder
Address
Preferred Package Size
Formulation Tel:
Fax:
E-mail:
1736 69 imMEDIAte Advan Bro 6pp
13/2/07
12:14
Page 3
Contact us United States SAFC Biosciences, Inc. 13804 W. 107th Street Lenexa, Kansas 66215 USA Tel: +1 913-469-5580 Toll Free – USA: 1 800-255-6032 Fax: +1 913-469-5584 E-mail: [email protected]
Europe SAFC Biosciences Ltd. Smeaton Road, West Portway Andover, Hampshire SP10 3LF UNITED KINGDOM Tel: +44 (0)1264-333311 Fax: +44 (0)1264-332412 E-mail: [email protected]
Asia Pacific SAFC Biosciences Pty. Ltd. 18-20 Export Drive Brooklyn, Victoria 3025 AUSTRALIA Tel: +61 (0)3-9362-4500 Toll Free – AUS: 1 800-200-404 Fax: +61 (0)3-9315-1656 E-mail: [email protected]
imMEDIAte ADVANTAGE™ is a trademark of SAFC Biosciences, Inc. © 2006 SAFC Biosciences, Inc. Issued December 2006
www.safcbiosciences.com
G052
Member of the Sigma-Aldrich Group
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