ABOUT MILLIPORESIGMA
In recent years, the field of messenger RNA (mRNA) has emerged as a groundbreaking technology with vast potential for revolutionizing the development of therapeutics. With tremendous versatility and a broad number of applications, mRNA-based approaches can be a pathway toward more precise, adaptable, and potentially curative treatments for a wide range of diseases.
As a novel class of therapeutics, the mRNA manufacturing process is not yet optimized or templated. Manufacturing complexity and regulatory uncertainty present further challenges. For companies advancing mRNA-based therapeutics, access to new technologies and expert services is essential for success as they ask: “How can I establish the best production process?”
MilliporeSigma, the life science business of Merck KGaA, Darmstadt, Germany, empowers you to unlock the potential of mRNA-based therapeutics. We understand the imperatives that innovators face, from enhancing molecule stability and process efficiency, to optimizing complex manufacturing workflows and navigating regulatory guidelines.
Our global organization is ready to address your specific needs with an integrated, customizable offering that encompasses:
- Industry-leading manufacturing purification technologies
- Bioprocessing raw materials and lipids for mRNA delivery and formulation
- Process analytical technologies (PAT), data analytics, automation, and control software
- Regulatory counsel and support
- mRNA contract development and manufacturing
- Collaboration labs equipped with scientific experts, innovative technologies, and flexible non-GMP facilities
Learn more about how we can help solve your mRNA manufacturing challenges. Visit our application webpages for more information on products and services for mRNA development and manufacturing and discover how we’re partnering with innovators to shape the future of this exciting field.
VIDEOS
WEBINARS AND PODCASTS
BROCHURES
- Custom Research-Grade mRNA Manufacturing Services
- CTDMO Services To Fast-Track The Advancement Of mRNA-Based Drugs
- Expert Partnership Contract Testing Services
- Analytical Development And Characterization For mRNA
- Remote Control And Automation Software Optimized For Bioprocess
- Enabling Capabilities And Solutions For All mRNA (Nucleic Acid) Platforms
- Cogent® Lab Systems For TFF At Process Development Scale
- Process Chemicals For RNA Drug Manufacturing
- Mobius® Power MIX Single-Use Mixing Systems
- Comprehensive Solutions For Your Vaccine Platforms
PRODUCT GUIDES, DATA SHEETS & APPLICATION NOTES
- Custom Research-Grade mRNA Manufacturing Services
- Accelerating Bulk Harvest Release Testing With A PCR-Based Solution
- Biopharmaceutical Application Guide
- Determining RNA Integrity And Purity By Capillary Gel Electrophoresis
- Lipid Nanoparticle Compositional Analysis By UHPLC-CAD
- Remote Control And Automation Software Optimized For Bioprocess
- Cogent® Lab Systems For TFF At Process Development Scale
- The Evolution Of AI: Benefits To Biopharma
- Mobius® Power MIX Single-Use Mixing Systems
- Chromatographic Purification Of Plasmid DNA
CONTACT INFORMATION
MilliporeSigma
400 Summit Drive
Burlington, MA 01803
UNITED STATES
Phone: 978-762-5100
FEATURED ARTICLES
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Explore the regulatory requirements for mRNA drug substances and products, the importance of phase-appropriate quality, and insights on creating CMC documentation to ensure compliance.
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Review the regulatory classification of LNPs, liposomes, and novel excipients as well as specific requirements outlined in regulatory guidance documents and strategies to navigate emerging challenges.
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Adventitious agent testing is frequently a bottleneck in downstream processing. Discover a PCR-based solution for manufacturing processes using CHO cells and animal origin-free components.
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RNA offers exciting potential for vaccines, gene therapies, and personalized medicine, but challenges related to stability, delivery, and manufacturing persist.
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To fully realize the potential of mRNA as a therapeutic or vaccine modality, developers will need to employ cutting-edge analytical methods to ensure the safety and efficacy of these novel products.
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Learn about a proprietary polymerase chain reaction (PCR) solution that was developed to overcome the challenges associated with pDNA that applies the high accuracy of PCR to mRNA manufacturing.
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Gain insight into how you can de-risk mRNA regulatory approvals with critical quality attribute characterization and lot release testing.
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Explore process and analytical development capabilities that can help you advance your formulation to GMP Manufacturing.
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Lipid selection impacts the final LNP drug product and the LNP process. Review critical quality considerations for lipids and the process requirements for successful commercial-scale manufacturing.
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Explore the differences between research-use-only oligonucleotides and those manufactured in compliance with GMP 21 CFR 820.
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This collection of insights highlights strategies and guidance to ensure reliable biomanufacturing capacity and supply chains for the delivery of health technologies, even during crisis conditions.
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Gain insight into the recent advancements in connectivity and integration technology, the associated challenges, and the importance of a vendor-neutral approach.
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Explore key points from the presentation MilliporeSigma delivered on the analysis and comparison of manufacturing costs between traditional and modern vaccines at the World Vaccine Congress Washington 2023.
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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 in mRNA-LNP products that support the development of safe and effective mRNA therapies.
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Here, we describe the use of a custom-designed cost model to explore the economics of vaccine manufacturing when using different modalities.
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Following successful Industry 4.0 implementation in the automotive, communications, aerospace, and other industries, the biopharma industry is now joining the digital revolution.
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Demand for mRNA-based medicine production continues to increase, as do investments in prophylactic and therapeutic indications. Explore a cost-model that compares all modalities.
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Biomanufacturers seeking a place in a competitive and lucrative future must start engaging in change now to meet the demands for delivering drugs more quickly to the patients who need them.