ABOUT MILLIPORESIGMA
The development of gene therapies offers both remarkable opportunities and unprecedented challenges. The underlying drivers of many diseases can be addressed with this modality, offering new hope to patients. At the same time, the path to approval is complicated by a lack of robust process templates, an evolving regulatory landscape, and the urgency of unmet medical needs.
In this uncertain environment, where speed and quality are essential, working with an experienced partner will empower you to bring gene therapies to life.
MilliporeSigma, the life science business of Merck KgaA, Darmstadt, Germany, is an industry leader in the field of gene therapy with more than 30 years of experience and broad expertise across the entire workflow. We understand the unique pain points that innovators face, from optimizing upstream and downstream workflows to meeting accelerated manufacturing timelines and navigating new regulatory guidelines. We can proudly state that we were the first gene therapy CDMO to produce a commercial product following a successful regulatory inspection.
Our global organization is ready to address your specific needs with an integrated, customizable offering that encompasses:
- Industry-leading manufacturing technologies for upstream, downstream, and formulation
- Process development and scale-up services
- Viral vector contract development and manufacturing
- Analytical development and biosafety testing for cell and gene therapies
- Regulatory support
- Collaboration labs equipped with scientific experts, innovative technologies, and flexible non-GMP facilities
Rely on our extensive experience to overcome your process development, production, and testing challenges.
Visit our application webpages for more information on products and services for gene therapy development and manufacturing and discover how we’re partnering with innovators to shape the future of this exciting field.
WEBINARS AND PODCASTS
BROCHURES
- Novel Enzyme For Nucleic Acid Removal At High Salt Concentrations
- Endonucleases With High Purity And Activity For Any Application
- CTDMO Services To Fast-Track The Advancement Of mRNA-Based Drugs
- A Versatile And Modality-Agnostic Aseptic Autosampling Solution
- Expert Partnership Contract Testing Services
- A 2 mL Automated Perfusion Cell Culture Platform
- Innovative Single-Use Tangential Flow Filtration (TFF) Devices
- Analytical Development And Characterization For mRNA
- Single-Use Modular Bioreactor For Fed-Batch And Perfusion Processes
- Filters Designed For Critical Small-Scale Gas Filtration
- Single-Use Film Engineered For Superior Strength And Leak Resistance
- Remote Control And Automation Software Optimized For Bioprocess
- Single-Use Sterile Sampling Assemblies
- M Lab™ Collaboration Centers
- Mobius® Essential Assemblies Specifications
- Roadmap To Success: Viral Clearance Services
- Ultrafiltration/Diafiltration (UF/DF) of Adeno-Associated Viruses (AAV)
- Comprehensive Solutions For Your Vaccine Platforms
- Next Generation Sequencing For Sequence Identity Confirmation And Variant Detection
- Medium For Producing High AAV Titers In Multiple HEK293 Cell Lines
- Viral Vector Manufacturing Capabilities
- Bio4C ProcessPad™ Software Datasheet
- Reduce Manual Tasks, Human Errors, And Operating Costs With Automation Software
- Natrix® Q Chromatography Membrane Best Practices Guide
- EX-CELL® CD Insect Cell Medium
- Sf-RVN® Platform
- Sf-RVN® Insect Cell Line
- NovaSeptum® GO Sterile Sampling Systems Brochure
- Bio4C Orchestrator™ Software Data Integrity Assessment
- Stemline® Platform Media – For Optimized Stem Cell Expansion
- CellPrime® rAlbumin
- Switching From Benzonase® Endonuclease Emprove® Expert To Benzonase® Endonuclease Safety Plus Emprove® Expert
- The VirusExpress™ Lentiviral Production Platform
- BioReliance® Gene Therapy Services
- Benzonase® endonuclease Safety Plus Emprove® Expert Data Sheet
- Benzonase® endonuclease Safety Plus Emprove® Expert Brochure
- Integrated Vector Production Capabilities
- Mobius® Power MIX 1000 And 2000 Single-Use Mixers
- Gene Therapy Capabilities For AAV And Lentivirus Production
- VirusExpress 293 AAV Production Platform
- Analytical Development & Characterization For AAV
- Optimization Of Benzonase® Endonuclease Use In Virus Purification
- Adeno-Associated Virus (AAV) Biosafety Testing & Characterization Services
- Single-Use Fluid Management
- VirusExpress® Lentiviral Production Platform
- A Transfection-Based Solution With Proven Performance At Scale
PRODUCT GUIDES, DATA SHEETS & APPLICATION NOTES
- AAV Process Intensification Using High Salt Lysis And Salt Tolerant Endonuclease
- Novel Enzyme For Nucleic Acid Removal At High Salt Concentrations
- A Versatile And Modality-Agnostic Aseptic Autosampling Solution
- Automated Aseptic Sampling For Upstream Bioprocessing
- A 2 mL Automated Perfusion Cell Culture Platform
- Testing Cell-Based Immunotherapeutics For Microbial Contaminants
- Optimizing And Scaling Lentiviral Vector Production
- Accelerating Bulk Harvest Testing Using A CHO Animal Origin Free Virus Panel
- Innovative Single-Use Tangential Flow Filtration (TFF) Devices
- Development Of A Novel Cell Culture Medium For AAV Production
VIDEOS
CONTACT INFORMATION
MilliporeSigma
400 Summit Drive
Burlington, MA 01803
UNITED STATES
Phone: 978-762-5100
FEATURED ARTICLES
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By addressing the complex needs of cell culture from the start, organizations can take steps to optimize their process, ensuring they are maximizing productivity and product quality.
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Examine how intensifying AAV production with high salt lysis and Benzonase® Salt Tolerant endonuclease enhances viral yield and infectivity while ensuring DNA removal for patient safety.
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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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Explore approaches for the capture and separation of capsids, upstream strategies for reducing the level of empty and partially filled capsids, trends in AAV capsid design impacting purification, and more.
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When it comes to determining the appropriate analytics to inform early development, there are a number of variables to consider surrounding cost, operator expertise, and throughput.
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The emerging trends in the biopharmaceutical industry are driving an even greater need for modular facilities and closed processing. Learn about the progression toward closed processing and more.
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With continuously evolving gene therapy regulations and guidance and limited time during development for testing, here are four points to consider when planning product-release testing of your gene therapy product.
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The COVID-19 pandemic underscored the vulnerability of global supply chains. Explore lessons learned from the pandemic, the concept of supply chain resilience, what to look for in a supplier, and more.
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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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We highlight strategies for ensuring the reliable delivery of health technologies with a focus on vaccines, mAbs, and new modalities manufactured by biotechnology companies and institutes.
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The analysis of over 10 variant callers and other bioinformatics tools for viral variant detection are discussed to better understand how the outcomes can improve gene therapy product characterization.
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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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Nearly forty biopharmaceutical companies, CDMOs, and research institute executives took part in interviews on the future of vaccine manufacturing. Explore the key findings following these interviews.
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Explore Cell & Gene therapy (CGT) products now within scope of the ICH Q5A guidance, technologies that can replace traditional testing strategies, viral clearance studies expected for vector products, and more.
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Our aim was to create scalable, single-use sparger and impeller designs that offer maximum performance capable of supporting high viable cell densities while cognizant of cell shear sensitivities.
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The aim of this work was to use a power number model-based approach for the design of a scalable single-use impeller capable of reaching high power densities with low mixing time and tip speed.
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Discover an experienced, flexible, and capable partner that can help you optimize production from MCB and WCB manufacturing to safe cell bank storage.
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In the biopharmaceutical industry, bag leaks remain a top pain point for customers. Ultimus® film addresses this costly issue, offering superior protection against leaks, abrasions, tears, and material fatigue.
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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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A growing number of AAV product developers are recognizing the value in moving to suspension as early in development as possible in order to optimize production.
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Since production templates depend on cell culture processes, biopharmaceuticals are susceptible to adventitious agent contamination. Explore a holistic overview of viral safety consolidating decades of expertise and process understanding.
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Learn how we simplify bringing life-changing molecules to market, from pre-clinical to commercial, with our CTDMO services designed to support global clients.
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What must we do as an industry to continue the momentum of cell and gene therapies and ensure these revolutionary treatments become a reality for patients who need them?
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MilliporeSigma experts and biomanufacturers discuss the importance of integration, collaboration, and education to address the industry paradigm shift towards novel modalities, continuous bioprocessing, and better risk mitigation.
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Guidance for your plasmid DNA downstream process development, exploring cell harvest, lysis, neutralization and clarification; chromatographic purification; TFF; and sterile filtration unit operations.
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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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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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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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The goal of clarification is to prepare the cell culture feed stream for downstream chromatography and purification. In this poster, we explore data driven strategies for clarifying harvest feed streams.
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Review the development of a suspension based AAV upstream production process that provides a more efficient and cost-effective bioprocessing solution for large scale production.
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This poster reviews two virus-based gene delivery platforms – adeno-associated virus (AAV) and lentivirus (LV) – focusing on the development, validation, and implementation of titration methods used to measure functional titer.
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MilliporeSigma’s new cell culture medium offers an improved alternative to classical formulations that can help address the constraints in viral vector manufacturing and scale-up.
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A guide to plasmid DNA downstream process development including clarification, TFF, chromatography, and sterile filtration unit operations.
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Mirror mirror on the wall, what is the promise that Gene Therapy holds for all? The urgency, uniqueness, and uncertainty surrounding gene therapy manufacturing creates many challenges. Let us take a look into the crystal ball of gene therapy to address unanswered questions and plan for what’s next.
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In this podcast, Ratish Krishnan, Associate Director for Cell & Gene Therapy talks about the tremendous promise gene therapies have for changing the healthcare paradigm and solutions to some of the biggest challenges in gene therapy manufacturing.
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With more gene therapy manufacturers needing to increase their batch size and efficiency, it’s necessary to invest in a viral vector manufacturing system that can be scaled up to meet commercial demand. In this infographic, learn how suspension systems offer many benefits that will help viral gene therapy developers enhance their processes and capabilities to better meet patient demands.
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This article explains the 4 Cs of Biopharma 4.0 - the software, automation and analytics tools that allow Control of unit operations, Connection across the process, Collection of data, and Collaboration such as remote support and cloud services.
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Learn about the history of gene therapy, critical factors for a successful path to commercialization, and how to enhance speed to market and improve quality with a templated process.
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With the current increase in development and investment, gene therapy companies will increasingly be looking to streamline the manufacture and commercialization of their therapies. Choosing a contract development manufacturing organization (CDMO) to ensure a smooth road to commercialization is essential. Contact us directly to learn more about picking the right strategic partner.
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While the fastest path is often tempting, the right path is to ensure product quality and viability while expediting the development timeline. These five steps are key to putting your molecule on the right path.
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In January 2020, the United States Food and Drug Administration (FDA) released several new or updated guidance documents pertaining to human gene therapy products. This paper summarizes several key changes that will impact developers of gene therapies.
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Biopharma 4.0 is becoming more tangible every day. Catch up on the initiatives and programs that are defining the application of Industry 4.0 principles for MilliporeSigma technologies and services.
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On the road to becoming a global industry leader in cell and gene therapy, our viral vector manufacturing organization has undergone a major transformation over the last two decades. Marc Gaal, Director of Program Management at MilliporeSigma, details the history of the business as well as some of the milestones achieved since its inception.
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The last decade saw a great rise in gene therapy popularity. Today, gene therapies have reached a momentum with hundreds in clinical development and several therapies approved in recent years. However, the rapid growth of the sector and the complexity of gene therapies has resulted in a number of challenges in process development, scale-up, manufacturing, and regulatory guidelines. Download the infographic to find out how to overcome these challenges and what’s ahead for gene therapy.
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The production of viruses, whether for use as viral vaccines, viral vectors for gene therapy, or oncolytic applications, requires complex processes that can translate into high costs, as well as slow development timelines and time to market. This article presents several case studies highlighting the advantages of process intensification using Natrix® single-use membrane chromatography to increase your productivity and reduce your capital and operational manufacturing costs.
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Diseases that lack a cure, or even treatment, may be addressed with new gene therapeutic classes. This potential has spurred new investments in the drug development and commercialization space.
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This article demonstrates that depth filters clarify AAV vectors, helping to overcome the unique separation challenges presented by these important vectors for gene therapy.
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With 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.
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The next decade will bring improvements including the development of alternative approaches to gene delivery, and advances in upstream and downstream processing, analytical methods and intensified/continuous processing.
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Process development (PD) is a critical component of the commercialization of viral vector-based therapies. Explore PD and four key factors to consider on the path to commercialization.