
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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To ensure mRNA product quality, it's important to confirm the integrity of the RNA. Examine the results of a study challenging the performance of the CGE method in assessing mRNA integrity and purity.
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Explore results generated from an internal study using a proprietary mRNA-LNP formulation and UHPLC-CAD, a powerful technique for the analysis of compounds that do not contain chromophores.
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Here, we provide a detailed description of assays for sequence identification and LNP composition, two CQAs of mRNA-LNP products, that support the development of safe and effective mRNA therapies.
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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 one facility's transition to closed processes for the expansion of suspension CHO and Sf9 cells and how the closed system compares to traditional processing.
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Conducting stability studies is a critical aspect of the drug development process. 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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We discuss regulatory expectations for the incorporation of alternative methods to prevent, remove, and detect contaminants focusing on comparability and strategies for easier substitution of current methods.
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A review of studies that 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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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.
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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.
CONTACT INFORMATION
MilliporeSigma
14920 Broschart Rd.
Rockville, MD 20850
UNITED STATES
Phone: +01 800 553 5372
BROCHURES
- Analytical Development And Characterization For mRNA
- 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
- Next Generation Sequencing For Biologic Production And Safety
- BioReliance® Cell Banking And Storage
- 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