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BioReliance Biologics Safety Testing Services BioPure Virus™ and BioPure Virus™ GOLD The Industry Standard for Virus Clearance Studies A critical component of every protein thera- peutic product development program is the validation of procedures used during the purification process. Manufacturing scientists must ensure that any potential contaminants present in the crude product preparation are reduced or eliminated during downstream purification steps. The validation of virus inactivation and/or removal during the down- stream process is a regulatory requirement. Therapeutic manufacturers have relied on BioReliance for over two decades to help them validate their downstream processes. BioReliance is the leader in this field, having helped provide the information necessary to introduce the first biotechnology derived products to the marketplace. We continue that leadership today, through the introduction of our BioPure Virus™ and BioPure Virus™ GOLD standards for use in virus clearance studies. BioPure Virus™ BioReliance has been producing virus stocks for use in virus clearance studies for over 25 years. We have recently characterized our production procedures to ensure that our standard virus preparation, BioPure Virus™, is ideal for nearly all viral clearance studies. BioPure Virus™ is produced from fully characterized virus stocks. These stocks are used by our highly experienced and dedicated virus production group to produce working material that is then subject to further purification and characterization to ensure high titers and low levels of potential contaminants. BioPure Virus™ GOLD For more sensitive virus clearance applications, such as the evaluation of nanofiltration steps, BioReliance now introduces the BioPure Virus™ GOLD virus preparation. These highly purified virus preparations are the product of BioPure Virus™ which has been subjected to additional purification in order to produce the cleanest and most aggregate free material for your clearance studies. BioPure Virus™ stocks are fully characterized and provide excellent performance for standard virus clearance studies BioPure Virus™ GOLD stocks are prepared to perform optimally for critical nanofiltration validation BioReliance provides the highest quality reagents, industry leading expertise and over 25 years of experience performing viral clearance studies

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BioRelianceBiologics Safety Testing Services

BioPure Virus™ and BioPure Virus™ GOLDThe Industry Standard for Virus Clearance Studies

A critical component of every protein thera-peutic product development program is the validation of procedures used during the purification process. Manufacturing scientists must ensure that any potential contaminants present in the crude product preparation are reduced or eliminated during downstream purification steps. The validation of virus inactivation and/or removal during the down-stream process is a regulatory requirement.

Therapeutic manufacturers have relied on BioReliance for over two decades to help them validate their downstream processes. BioReliance is the leader in this field, having helped provide the information necessary to introduce the first biotechnology derived products to the marketplace. We continue that leadership today, through the introduction of our BioPure Virus™ and BioPure Virus™ GOLD standards for use in virus clearance studies.

BioPure Virus™

BioReliance has been producing virus stocks for use in virus clearance studies for over 25 years. We have recently characterized our production procedures to ensure that our standard virus preparation, BioPure Virus™, is ideal for nearly all viral clearance studies. BioPure Virus™ is produced from fully characterized virus stocks. These stocks are used by our highly experienced and dedicated virus production group to produce working material that is then subject to further purification and characterization to ensure high titers and low levels of potential contaminants.

BioPure Virus™ GOLD

For more sensitive virus clearance applications, such as the evaluation of nanofiltration steps, BioReliance now introduces the BioPure Virus™ GOLD virus preparation. These highly purified virus preparations are the product of BioPure Virus™ which has been subjected to additional purification in order to produce the cleanest and most aggregate free material for your clearance studies.

BioPure Virus™ stocks are fully

characterized and provide

excellent performance for

standard virus clearance studies

BioPure Virus™ GOLD stocks are

prepared to perform optimally

for critical nanofiltration

validation

BioReliance provides the highest

quality reagents, industry

leading expertise and over 25

years of experience performing

viral clearance studies

www.bioreliance.comNorth America Toll Free: 800 553 5372 Tel: 301 738 1000

Europe & International Tel: +44 (0)141 946 9999 • Japan Tel: +81 (0)3 5796 7430Email: [email protected]

©2012 Sigma-Aldrich Co. LLC. All rights reserved. BioReliance and SAFC are trademarks of Sigma-Aldrich Co. LLC or its Affiliates, registered in the US and other countries. F-0730912

BioRelianceBiologics Safety Testing Services

Lot Specific Data for BioPure Virus™ and BioPure Virus™ GOLDWhen performing virus clearance studies with BioReliance, clients will receive documentation clearly indicating the characteristics of the virus materials used during the studies. Here’s an example of a product information sheet for BioPure Virus™ GOLD MMV:

For Virus Clearance Studies, You Can Rely On UsBioReliance is continually working to improve the level of service we can provide our clients for performing their critical viral clear-ance studies. From our new BioPure Virus™ stocks to our Complete Clearance™ offering, we have the expertise and experience you need to ensure success in your purification process development program.

For more information on these or any other of BioReliance’s industry leading clearance services, please contact your Account Manager or email us at [email protected].

SAMPLE

BioPure Virus™ and BioPure Virus™ GOLD, continued