
ABOUT MILLIPORESIGMA
Choosing the right partner for your analytical and biosafety testing is critical in the race to approval. Our BioReliance® testing services offer exceptional, risk-mitigating solutions with technical and regulatory expertise, to help you bring life-changing drugs to market. 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, analytical development, and biomanufacturing 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
FEATURED ARTICLES
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An essential part of AAV vector production is the characterization of potential CQAs. Learn about novel, robust, and orthogonal methods that can be used to assess identity, purity, and residuals.
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NGS-based methods for agnostic broad range detection are suitable options to augment or replace current virus testing methodology. Explore a NGS AAT method for cell line characterization and more.
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Learn about our transition to closed processes for expansion of suspension CHO and Sf9 cells and how the closed system compares to traditional processing.
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Learn how consolidating stability testing with a single partner offers improved efficiency, reduced risk, and more.
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Learn more about the analytical development for mAbs and recombinant proteins
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Review currently available literature and our recommended COVID-19 virus detection test methods and susceptibility of common biological host cells to infection.
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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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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.
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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.
CONTACT INFORMATION
MilliporeSigma
14920 Broschart Rd.
Rockville, MD 20850
UNITED STATES
Phone: +01 800 553 5372
BLAZAR™ PLATFORM: ACCELERATES VIRAL DETECTION FROM WEEKS TO DAYS
- Accelerate Viral Detection
- Alternatives To In Vivo Assays For Biosafety Testing Of Biologics
- Rapid Biosafety Testing Enables The Future Of Manufacturing
- Blazar Platform: Rodent Virus Panel
- The Blazar® Platform In A Minute
- Accelerate CHO Cell Characterization With The Blazar® Rodent Panel
- Blazar® Platform: Rodent Virus Panel From The BioReliance® Portfolio
BROCHURES
- Roadmap To Success: Viral Clearance Services
- Expert Partnership Contract Testing Services
- Analytical Development & Characterization For AAV
- Reveal Your Biologic’s Attributes Earlier And Faster With Expert Guidance
- Closed Processing Cell Bank Manufacturing Services
- NGS Applied To Biologic Production And Safety
- BioReliance® Cell Banking And Storage
- 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