
ABOUT MILLIPORESIGMA
The life science business of Merck KGaA, Darmstadt, Germany brings together the world-class products and services, innovative capabilities and exceptional talent of EMD Millipore and Sigma-Aldrich to create a global leader in the life science industry.
At MilliporeSigma, our mission is to help our customers improve human health and life worldwide. This commitment means providing leading life science products and services in ways that also help improve the communities and environment in which we all live.
We re-imagine a future in which:
- Access to health and clean water is available to everyone around the world;
- Life science products not only advance human health, but also help restore and preserve our world; and
- Companies work in harmony with their communities to improve human lives.
We aren’t just re-imagining this future. We are working towards it every day. We invite you to learn more about our leadership commitment and our approach to corporate responsibility, as well as our goals and accomplishments for future-forward products, streamlined operations, and inspired people within and outside of our company.
HOT PRODUCTS
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Designed to purify biologics at clinical and process scale, the Mobius® FlexReady Solution with Smart Flexware® Assemblies is flexible, allowing you to have a single system for tangential flow filtration (TFF) at various scales.
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Bio4C™ Orchestrator connects to individual unit operations from a centralized “orchestration layer” for complete visibility, monitoring, and management of regulatory-compliant biomanufacturing systems and processes. Bio4C™ Orchestrator’s consolidated control optimizes processes improving quality and compliance while reducing human errors and operating costs.
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To ensure optimum equipment uptime and regulatory compliance while mitigating risks, MilliporeSigma has developed System Service Reliance Plans; a complete range of services for your systems and equipment. These comprehensive service and support packages allow you to select a coverage level that best fit your needs. The Essential Reliance Plan includes a selection of preventive maintenance and troubleshooting services while the Advanced Reliance Plan provides higher coverage, with faster response time and priority access to remote and on-site support. All services are performed by MilliporeSigma’s global experts who have intimate knowledge of the equipment, backed by decades of experience.
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MilliporeSigma’s Mobius® single-use mixing solutions deliver advanced technology for mixing pharmaceutical ingredients from intermediate to final drug products and for the preparation of process solutions, such as buffers and media. Unlike traditional stainless-steel mixers, single-use mixers reduce downtime due to CIP, SIP, cleaning validation, and process engineering. Mobius® single-use mixing solutions also offer operational flexibility as they can be up and running in less than five minutes. They are capable of mixing speeds up to 1000 RPMs meeting the broadest range of mixing production requirements. Mobius® flexibility offers you a choice of just the right filter, connector, tubing options for your specific application and environment, including sterile interfaces, from fermentation to final fill. Sizes range from 10 L to 3000 L.
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You’re developing lifesaving gene-modified cell therapies and need to manufacture lentiviral vector as quickly as possible. But scale-up and regulatory hurdles make the path to the clinic slow and labor intensive.
We're here to help.
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From your bioreactor to final sterile filtration, the new NovaSeptum® GO sampling system lets you sample processes the way you want. Flexible formats and volumes adapt to your process for robust, reliable monitoring and quality assurance.
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Cell culture media are important for process efficiency and mAb quality. Production media support initial cell growth and production, while the feeds replenish depleted nutrients required for cellular function and maintain and extend the production phase in fed-batch mode.
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Cellvento® CHO media are designed to support growth and maintenance of specific CHO cell lines in suspension cell culture for expression of monoclonal antibodies and recombinant proteins. The new Cellvento® 4CHO-X Expansion Medium supports cell expansion including N-1 perfusion for Chinese Hamster Ovary (CHO) cell lines.
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In recent years, the development of media used to expand and mature adult stem cells has greatly increased the success rate of adult stem cell therapy and the breadth of potential stem cell-based therapies. To obtain enough cells, ex vivo expansion has been utilized to ensure successful engraftment and economize the manufacture of both allogeneic and autologous therapies.
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Bio4C ProcessPad™ software is a data collection, visualization, and analytics software platform that facilitates 21 CFR Part 11 compliance and enables bioprocess monitoring, lifecycle management, reporting, investigations, and continued process verification (CPV).
VIDEOS
BROCHURES
- BioReliance Viral Vector Manufacturing Capabilities
- Bio4C ProcessPad™ Software Datasheet
- Reduce Manual Tasks, Human Errors, And Operating Costs With Automation Software
- Sf-RVN® Platform For Improving The Safety Profile Of Your Vaccines Process
- Natrix® Q Chromatography Membrane Best Practices Guide
- ekko™ Acoustic Cell Processing System Specification Sheet
- ekko™ Acoustic Cell Processing System Data Sheet
- EX-CELL® CD Insect Cell Medium
- Sf-RVN® Platform
- Sf-RVN® Insect Cell Line
WEBINARS AND PODCASTS
PRODUCT GUIDES, DATA SHEETS & APPLICATION NOTES
- Bioprocessing And Scaleup Of HEK293 Cells For AAV Production
- Bio4C ProcessPad™ Software Datasheet
- Reduce Manual Tasks, Human Errors, And Operating Costs With Automation Software
- Lay The Proper Foundation For Upstream Success
- Natrix® Q Chromatography Membrane Best Practices Guide
- A Platform Standard For Viral Vector Manufacturing And Commercialization
- ekko™ Acoustic Cell Processing System Specification Sheet
- ekko™ Acoustic Cell Processing System Data Sheet
- EX-CELL® CD Insect Cell Medium
- Sf-RVN® Insect Cell Line
NEWS
- MilliporeSigma Announces Support Of SaudiVax In Becoming First Developer And Manufacturer Of Halal Vaccines And Biotherapeutics In Saudi Arabia
- MilliporeSigma To Manufacture Next-Generation Biotherapeutics For Alteogen
- MilliporeSigma Announces Organizational Transformation To Strengthen CDMO Offering And Accelerate Future Growth
- MilliporeSigma’s Bio4C Orchestrator™ Software Optimizes Processes, Improves Compliance And Time To Market
- MilliporeSigma’s Latest Technologies Earn Industry Recognition For Accelerating Bioprocessing 4.0
- MilliporeSigma Advances Bioprocessing Capabilities With Raman Technology Sensor Acquisition
- MilliporeSigma Accelerates Readiness Of Bioprocessing Facility Of The Future
- MilliporeSigma Boosts Commercial Viral Vector And Gene Therapy Manufacturing Capacity
CONTACT INFORMATION
MilliporeSigma
400 Summit Drive
Burlington, MA 01803
UNITED STATES
Phone: 1-800-645-5476
NAVIGATING THE EMERGING BIOTECH ECOSYSTEM
- Navigate The Path To Commercialization For Biotech Start-Ups
- Regulatory, Funding And Outsourcing Best Practices For Biotech Start-ups
- Biotech Start-up Welcome Kit For Bioprocessing
- Pathways For Pioneers: Biopharmaceutical Start-Up Path To Commercialization
- Integrated Bioprocessing For Biotech Start-ups
FEATURED ARTICLES
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With a diverse landscape of potential partners, it is important to know what qualities to look for in a technology provider and how to traverse the challenges inherent in managing multiple relationships.
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MilliporeSigma has developed the VirusExpress®️ AAV Production Platform as a scalable upstream AAV production solution for viral gene therapies.
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There is no one-size-fits-all model for AAV gene therapy products when it comes to viral clearance studies. Here we address some of the questions with respect to viral clearance studies for AAV vectors.
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When selecting a partner for development of upstream processes you need speed, quality and regulatory compliance – all appropriately balanced.
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Learn more about platform technologies that are being developed and implemented to support large-scale production of viral vectors.
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Because viral safety is essential in the manufacture of biopharmaceuticals, we developed a proven Sf9-rhabdovirus-negative insect cell line that improves the safety profile of our customers’ bioprocesses.
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This e-book contains a series of case studies highlighting our recent collaborations with organizations and thought leaders on the front lines of the battle against challenging pathogens and infectious diseases.
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Considering the complexity of bioprocessing and the industry’s inherent “data siloes,” this paper focuses on how companies can use the power of smart data to leverage AI and drive additional insights.
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Read more on trends related to outsourcing and share what attributes of an outsourcing partner that are sought by developers and manufacturers of biopharmaceuticals.
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Our experts share key considerations for biopharmaceutical companies as they advance to commercial manufacturing and navigate complexities associated with business planning, process scale-up, optimization and validation, technology considerations and regulatory compliance.
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Cost modeling can be a powerful tool to assist with prioritizing areas of focus for process improvement during process development and especially useful for processes producing viral vectors for gene therapies.
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This whitepaper describes the development of a novel Sf-RVN® cell line, with companion chemically defined medium, the EXCELL® CD Insect Cell Medium which can be combined and offer a Sf-Rhabdovirus free alternative for the BICS production of biologics.
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Assurance of viral clearance can be difficult, however, during production of vectors such as adeno-associated viruses (AAV) used for the purpose of gene delivery. The need to define and deploy an appropriate and robust viral clearance strategy can be particularly challenging without an overarching strategy in place.
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Explore how the ekko™ Acoustic Cell Processing System enables user-friendly automation of the harvest, wash, and concentration steps required to prepare T cells for preservation.
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The ekko™ System overcomes the challenges of concentrate and wash steps throughout the cell therapy process by employing acoustic technology to gently process cells.
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Explore the regulatory requirements for software in a biopharmaceutical GxP environment and why software is invaluable for creating an audit trail, reporting, and automating regulatory-related tasks.
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It is critical to vet not just the expertise available at a CDMO, but also the effectiveness of their facility design to reduce risk and meet scale-up needs.
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Insights and advice from a team of experts about how to leverage strategic approaches to process development and risk management while meeting strict timeline and regulatory requirements.
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How much quicker and easier would it be if we could know the process’s health by looking at a single metric rather than checking hundreds of parameters?
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By unlocking the value of an integrated solutions provider, you can leverage a comprehensive suite of advanced technologies and expertise that will facilitate your path to market and benefit you for the lifetime of your product.