
ABOUT MILLIPORESIGMA
Choosing the right partner for analytical and bioanalytical services is critical in the approval race. MilliporeSigma’s BioReliance® Testing Services offer exceptional, risk-mitigating solutions to help you bring life-changing drugs to market, faster. Our testing and manufacturing services span the product cycle from early pre-clinical development to licensed production. Partner with us to meet your needs for Biologics Safety Testing, Product Characterization, Biomanufacturing Services, and Toxicology Services. See our full suite of capabilities.
© 2020 Merck KGaA, Darmstadt, Germany and/or its affiliates. All Rights Reserved.
The life science business of Merck KGaA, Darmstadt, Germany operates as MilliporeSigma in the US and Canada
CONTACT INFORMATION
MilliporeSigma
14920 Broschart Rd.
Rockville, MD 20850
UNITED STATES
Phone: +01 800 553 5372
BROCHURES
- MilliporeSigma’s BioReliance Testing Services Specification Sheet
- Product Characterization Assay Package - Interlot And Biosimilar Comparability
- Product Characterization Assay Package - Cell Line Development
- Product Characterization Assay Package - Impurities
- Product Characterization Assay Package - Lot Release And Stability Testing
FEATURED ARTICLES
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Review key methods which are applied to ensure safety of such recombinant proteins, with a focus on alternate and superior methods to the standard transmission electron microscopy (TEM) method.
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This paper discusses the regulatory expectations for incorporation of alternative methods with a focus on comparability and strategies for easier substitution of current methods.
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A review of studies which involve scaling down individual process steps, and for each step, spiking virus into the specific process intermediate, performing the process step and measuring the remaining virus.
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Did you know about the alternative rapid method for in vivo MAP/HAP/RAP testing? Download our tech note Blazar™ Platform: Rodent Virus Panel From The BioReliance® Portfolio to learn more about our novel degenerate PCR assay designed for the detection of a broad range of adventitious agents.
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The Blazar Rodent Panel allows biopharma to move away from traditional in vivo antibody production assays when characterizing cell banks of rodent origin used in the production of biologicals.
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By amplifying multiple targets within a conserved region of the viral family genome, Blazar detects a much broader range of adventitious viruses as compared to traditional polymerase chain reaction methods.
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What was once a check-the-box procedure in standard stability testing now requires a deeper understanding of the molecule, its behavior, and what effect it has on the patient.
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Combatting the challenges of developing and manufacturing antibody-drug conjugates (ADCs) requires robust product characterization throughout all phases of development.
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Because characterization and comparison of originator and biosimilar candidate mAbs is challenging due to their complex and variable structures, a range of analytical techniques should be employed.
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The relationship between physicochemical profile and biological activity — and how this relationship affects clinical performance — is key to informed decisions, accelerated development, and risk reduction.