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.


TOOLS

Chromatography Volume and Flow Rate Calculator

WEBINARS

In the last decade, biopharmaceutical industries have had to mobilize quickly in response to pandemics. Developing vaccines and manufacturing large doses in an emergency is often constrained by existing platforms and facility set ups. Vaccine manufacturing needs to evolve to tackle future global health challenges. Watch this webinar to learn more.

Early viral vector process development for cell and gene therapies is critical to assure a production strategy that supports commercial needs. In this webinar, you will learn the importance of planning for scalability and manufacturability from the earliest stages of process development and how a scalable templated process can reduce time needed to move from product development to commercialization. 

Is viral clearance a hurdle to implementing continuous processing? In this webinar, we will share virus spiking alternatives that may pave the way for effectively evaluating viral clearance by chromatography steps in a continuous process.

With increases in development and investments in the gene therapy field, companies will increasingly be looking at manufacturing and commercialization of their therapies. Road to commercialization goes through a series of process validation phases. In this webinar, we take a closer look at the road to commercialization and focus on addressing primary questions.

With the rise of gene therapy as a promising treatment modality, the industry is facing increasing pressure to decrease overall manufacturing costs, shorten product development timelines and increase production. This webinar focuses on intensified downstream process using high-productivity, single-use chromatography membrane adsorbers.

This webinar serves as an overview of key aspects associated with pDADMAC flocculation implementation, including data for cleanability of stainless-steel surfaces soiled with pDADMAC flocculated cell culture.

This presentation addresses product characterization strategies to de-risk the manufacturing of mAbs and cell and gene therapies. It also covers detection and characterization of host cell proteins (a factor in mAb therapies and cell and gene therapies), and polyethylenimine used in cell and gene therapies.

While no viral contamination has been reported so far for novel viral therapies, it is important to learn from historical experience and leverage improved manufacturing and testing methods to increase their safety. 

Process development is a critical enabler to bring safe, effective, sustainable products to market to address patient needs. In this webinar we will discuss our strategies for developing lentivirus and adeno associated virus (AAV) and the impact these early decisions can have on commercial readiness.

Outsourcing or implementing a streamlined buffer preparation and management systems allows biomanufacturers to considerably reduce floor usage, labor and costs. In this webinar, we will explore the benefits of an Integrated Buffer Delivery Platform.

CONTACT INFORMATION

MilliporeSigma

290 Concord Road

Billerica, MA 01821

UNITED STATES

Phone: 781-533-6000

HOT PRODUCTS

  • Series 4000™ Single Round Filter Housings

    New family of our housing portfolio designed to meet the demands of filtration process design. Series 4000™ housings have been designed in accordance with the life sciences industry’s demand for high-quality and cost-effective products. Our Series S4000™ housings are suitable for use in a wide range of applications with low dead volume, minimizing product loss and enhancing cleanability. The products are available in T-Line and In-Line configurations including the 5, 10 ,20, 30-inch sizes in Code 7.

  • Mobius® Chrom 20 System

    The Mobius® Chrom 20 system is a flexible, automated, single-use chromatography system that enables consistent and reliable separation and purification of mAbs, vaccines, plasma, and therapeutic proteins at clinical and process scales.

  • Natrix® Q Chromatography Membrane

    For single-use per batch biomolecule purification

    A high capacity, high throughput strong anion exchange chromatography membrane designed for single-use per batch biomolecule purification. The unique Natrix® Q membrane contains a high density of quaternary amine ligands that are directly polymerized within the porous membrane scaffold.

  • Cellicon™ Perfusion Filter And Controller

    The benchtop Cellicon™ Perfusion Solution is designed to meet your perfused seed train challenges.

     

  • Cellvento® 4CHO-X

    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.

  • Benzonase® endonuclease Safety Plus Emprove® Expert

    Benzonase® endonuclease — the smart solution for DNA removal in biopharmaceutical production.

  • Plasma Processing Capabilities

    Plasma Fractionators play a critical role in the treatment of rare life-threatening conditions. Consistent, reliable performance is key to plasma fractionation – and that means choosing a partner who understands your challenges of improving yield while maintaining process economics and managing ever-increasing regulatory requirements.

  • NovaSeptum® GO Sterile Sampling Systems

    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.

  • Millipore Express® SHC Hydrophilic Filters

    Millipore Express® SHC (Sterile, High Capacity) filters provide superior throughput and capacity in applications where sterilizing-grade performance is needed and premature filter plugging is a concern. These filters are ideal for sterile filtration of cell culture media, protein solutions and other high fouling fluids. Millipore Express® SHC filters contain two polyethersulfone membrane layers, 0.5 μm/0.2 μm, and come in a range of device formats and sizes to suit your application needs.

  • Single-Use Mixer For Difficult-To-Mix Biopharm Ingredients

    MilliporeSigma’s Mobius® Power MIX 2000 single-use mixing system is engineered with advanced technology to effectively handle difficult-to-mix buffers, culture media powders and other pharmaceutical ingredients. The Mobius® Power MIX achieves a strong vortex using an impeller design and motor based on magnetically-coupled NovAseptic® technology, a proven mixing technology in stainless steel tanks. The Power MIX 2000 provides accessible, sterile zero deadleg sampling directly from the mixing container. A Probe Port allows for insertion of either a reusable probe for non-aseptic processes or a pre-sterilized, single-use sensor for in-process pH measurement of aseptic processes. Other design features make the mixing system easy to use, enabling loading of bags by one person and offering an optional integrated hoist for powder delivery.

  • Intelligent Virus Defense: Centinel

    Viral Resistance For The Future.
    Centinel™ technology goes beyond viral insurance. It’s an integral component of a sophisticated virus mitigation strategy for preventing, detecting and removing viruses.

  • Virus Safety Solutions: Viresolve®

    The next generation parvovirus safety solution designed to provide the highest levels of retention assurance and productivity.

FEATURED ARTICLES

  • Covid-19 Impact On Bioprocessing: PART 2 Fears To Be Addressed Due To Covid-19

    We interviewed major biopharmaceutical industry senior bioprocessing decision-makers, and bioprocessing suppliers in the US and Europe. The impact on emerging biopharma companies as well as smaller suppliers may actually be a small silver-lining for some, during this global, horrific event.

  • Addressing The Evolving Information And Automation Needs Of Biopharma

    A dramatic increase in the amount of information that is available, in parallel with a reduction in the cost of obtaining, processing, and transmitting information, is changing the way biopharmaceutical manufacturers operate. Access to information, and more importantly, strategic use of it, can give a company a competitive advantage.

  • A Streamlined Approach To Analytical Method Development And Implementation

    The development and implementation of analytical methods are essential for success at all phases of a molecule’s journey, from pre-clinical development, to clinical manufacturing and ultimately, commercialization. Driven by the need for rapid advancement towards key milestones, an early-stage company must optimize the balance of speed and safety, while ensuring quality and gathering important information about the molecule.

  • Covid-19 Impact On Bioprocessing: PART 1 Accelerating Trends

    Because of the urgent demand for treatments, vaccines and assays, the pharmaceutical and biotech industries are experiencing disruptive, often chaotic, increased demands on its resources. This industry adaptability is already helping the industry re-tool for rapid development and production of pandemic vaccines, therapeutics, equipment and diagnostics; while also responding to changes that this worldwide mobilization of resources will bring to the industry.

  • Automating Data Analytics Addresses Business Drivers, Accelerates Transition To Bioprocessing 4.0

    The race is on to get biotherapeutics to market faster as every day of delay is delayed access for patients and can result in millions in lost revenue. Following successful Industry 4.0 implementation in the automotive, communications, aerospace, and other industries, the biopharmaceutical industry is now joining the digital revolution to meet the manufacturing challenges of today and tomorrow.

  • Leveraging The 4Cs To Deliver Bioprocessing 4.0

    Biomanufacturers are facing immense pressures to increase their productivity and deliver high-quality biotherapies to market faster. This blog explains the “4 Cs” of Biopharma 4.0 – the software, automation, and analytics tools that provide interconnection, information transparency, and decentralized decision making.  

  • Successful Drug Development With Synthetic Lipids: Critical Aspects And Strategies

    Lipid-based drug delivery systems offer several advantages, including improving the stability, solubility, bioavailability, and toxicity profiles of active pharmaceutical ingredients (APIs). It is essential to select the optimal lipid excipients with the appropriate characteristics for each specific API and application and to ensure that they can be produced using high-quality production methods that are scalable for GMP manufacturing. Working with the right supplier that offers consistent, high-quality products and has expertise in the drug development process and the regulatory environment is essential for the successful development and commercialization of lipid-based drug products.

  • The Intersection Of Advanced Process And Digital Technologies

    As industry 4.0 principles are applied to the biomanufacturing arena and innovative digital technologies emerge, one might refer to the phenomenon as “convergent bioprocessing.” 

  • Considerations For Bioreactor Process Development And Scale-Up For Transient Transfection-Based Lentivirus Production In Suspension

    Several challenges are associated with use of an adherent platform for lentivirus production. This white paper describes considerations for suspension-based, transient transfection bioreactor process development and scale-up of lentivirus production. We will describe the approach taken for process development.

  • Downstream Process Intensification For Virus Purification

    An overview of the challenges presented by current approaches to virus production and a platform approach that can work across different viral modalities and accelerate process development.

  • Proven Strategies To Accelerate Drug Development

    In this ebook, we describe four areas of development where we have applied a strategy to accelerate timelines, mitigate risk, and ensure uncompromising quality.

  • Process Development For Viral Vector Manufacturing

    Process development is a crucial step in viral vector manufacturing and a successful CDMO partnership can help navigate the challenges associated with scaling your viral vector. This infographic outlines the history of gene therapy and presents critical factors that need to be taken into consideration for a successful path to commercialization. It also explains how to enhance speed to market and improve quality with a templated process.

  • Choosing A Cell Line Development Provider

    One of the biggest decisions a biological medicine developer makes is to move forward with manufacturing theirproduct. It's one of the most costly and complex decisions you'll make.

  • Accelerating Cell Line And Process Development

    This paper describes rapid identification of high-producing cell lines, media feed optimization, and a bioreactor scale-up approach for consistent, reliable upstream bioprocess development.

  • Upstream Viral Safety: A Holistic Approach To Mitigating Contamination Risks

    The safety of biologics from adventitious agents requires a multilayered strategy of controlled manufacturing processes and risk mitigation to prevent contamination. 

  • Strategies For Upstream Intensification

    Upstream intensification is one strategy that will enable the Facility Of The Future by significantly driving down costs through an increase in volumetric productivity. Read the white paper to learn more!

  • The Importance Of Scalability In Viral Vectors

    Gene therapy has the potential to change countless patients’ lives. Diseases that lacked cures or even treatments may be addressed with these new classes of therapeutics. This potential has spurred new investments in the drug development and commercialization space.

  • How Pandemics And Outbreaks Have Influenced The Adoption Of Single-Use Vaccine Manufacturing

    In the last decade, biopharmaceutical industries have had to mobilize quickly in response to pandemics. Vaccine development typically requires many years and manufacturing large doses in an emergency is a challenge. To reduce investment risk, biomanufacturers wait until a vaccine is in the advanced stages of testing before starting to manufacture. This conventional development strategy compresses during a pandemic. Read our white paper to learn more.

  • Optimize Your Biologic’s Analytical Program For Greater Risk Reduction

    In this ebook, our experts share some critical success factors for your analytical program—including speed, risk, and cost—and how a risk-based approach can effectively get you to your next milestone.

  • Enabling Perfusion Processes With Cell Retention Technologies

    In this white paper, we explore various strategies for the intensification of upstream perfusion processes with cell retentio technologis and the viability of each solution.

  • Robust Harvest Clarification For Adeno-Associated Viral Vectors Via Depth Filtration

    This article demonstrates that depth filters clarify AAV vectors, helping to overcome the unique separation challenges presented by these important vectors for gene therapy.

  • Rapid Biosafety Testing Enables The Future Of Manufacturing

    This whitepaper explores the factors driving the evolution toward faster biosafety testing and describes rapid approaches for adventitious agent testing that are more aligned with manufacturing trends.

  • Vaccine Bioprocessing Handbook

    What technologies should you apply to your vaccine-specific process? Vaccines have been protecting against disease since the late 1700s. They function by triggering the immune system to generate short-term and long-term responses. Because there are many pathogens, there are also many vaccines. They can be classified by antigen character, but the manufacturing flows used to produce them are relatively similar. Learn more on similarities and differences.

  • Understanding The Road To Commercialization

    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.

  • Aseptic Process Sampling Risk Mitigation – A Regulatory Perspective

    This whitepaper provides a summary of regulatory guidelines for sampling, describes traditional methods and their limitations, and explores the advantages of aseptic, single-use to align with regulatory guidelines.

  • Hiring Challenges In Bioprocessing For Start-Ups

    Hiring bioprocessing pros has been a stubborn problem for more than a decade, challenging start-up companies as the supply of qualified staff gets tighter. Here's how the industry could solve the problem.

  • The Race From Lab To Clinic: 5 Critical Steps To Success

    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.

  • A Cost Analysis And Evaluation Of Perfused Seed Train Scenarios Through Process Modeling

    This white paper describes process modeling and compares the process economics of a conventional upstream process versus three perfused seed train alternatives in combination with either a conventional fed-batch bioreactor or high-seed fed-batch bioreactor. 

  • Updated US FDA Guidance For The Gene Therapy Industry: Key Changes And Areas Of Increased Focus

    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.

  • How MilliporeSigma Handles Quality Inspection Readiness

    While quality management is a major priority across the life sciences industries, it takes specific precedence in viral gene therapy. Heather Burnell, Head of Quality at MilliporeSigma’s viral vector manufacturing facility in Carlsbad, CA, highlights how quality management is embedded in the MilliporeSigma culture.

  • Process Development Is Key To Patient Success

    Process development (PD) is a critical component to the commercialization of viral vector-based therapies. While some gene therapy developers may want to speed through this operation to meet deadlines, doing so can put product quality, safety, and efficiencies at risk.

  • Risk Mitigation Strategies For Raw And Starting Materials Used In Gene Therapies

    Recently approved cell and gene therapies are delivering impressive results for patients who otherwise have exhausted all treatment options or have had no options available to them. However manufacturers are faced with many challenges in the journey from development to commercialization. Within this challenging environment, a number of risk mitigation strategies related to the materials used to produce viral vectors can be employed to help accelerate progress towards commercialization of these remarkable therapeutics.

  • Seed Train Intensification Using High Cell Density Cryopreservation

    High cell density cryopreservation and the use of a perfused seed train and specially-designed expansion medium can create shorter lead times, reduce plant footprint, increase flexibility and reduce COGs.

  • Reducing The Risk During Cell And Gene Therapy Development And Manufacturing

    While these new modalities are generating significant excitement among patients and caregivers, cell and gene therapy manufacturers are experiencing growing pains. The rapid growth and continued momentum of the industry has led to the issuance of new guidance. In this article we share insights for navigating within a novel and complex regulatory environment, mitigating risks posed by raw materials and implementing proper risk assessments during manufacturing.

  • Further Adapting New Bioprocess Technology In An Era Of Change

    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.

  • The Future Of MilliporeSigma’s Gene Therapy CDMO Through The Lens Of History

    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.

  • Designing Quality Into Chromatography Resins To Minimize Variability

    This article explores the strategies and close collaboration employed by MilliporeSigma to design quality into resins and membranes and to help customers minimize variability in their purification process.

  • Alternatives To In Vivo Assays For Biosafety Testing Of Biologics

    Even as alternative methods such as PCR and NGS have emerged, in vivo tests have stubbornly remained a central part of testing. Here we examine current in vivo methods and explore modern alternatives.

  • Strengthen Your Chromatography Resin Supply Chain

    This white paper explores key components of a chromatography resin supply chain program to help customers control their supply chains and ensure steady progress towards milestones.

  • Gene Therapies: Overcoming The Biggest Hurdles In Manufacturing

    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.

  • A Molecule’s Journey: Break Down Roadblocks To Clinical Success

    The key to a biopharma executive's success is making the right decisions at the right time. Which will get your biologic to the clinic quickly and cost-effectively, without compromising quality and patient safety?

  • Greater Transparency; Fewer Shortages

    A major contributing factor to drug shortages is the availability of raw materials. Read how greater transparency in supply chains will help address shortages.

  • New Paradigms In Viral Safety

    With next generation bioprocessing and innovations in detection and clearance technologies it is time to rethink the traditional approaches to viral safety

  • Process Monitoring, Data Management Approaches For Bioprocess Challenges

    Setting up systems to automatically compile data and analyze it on a routine basis versus just collect it reduces workloads, provides timely access to critical information, and allows for data-driven decisions.

  • Strengthening Biopharma Supply Chains

    Supply chains are increasinly complex. Collaboration can give you confidence in supply robustness and control. This collection of articles offers tips and insight to keep your supply chain running smoothly.

  • Vaccine Manufacturing: Collaboration Overcomes Process Challenges

    This white paper showcases the efforts carried out by the DiViNe consortium to advance the use of an innovative affinity chromatography platform during vaccine manufacturing.

  • Accelerated, Cost-Effective Adenoviral Vector Vaccine Manufacturing

    This whitepaper describes our collaboration with the Jenner Institute, Oxford University to develop an optimized, single-use GMP process for manufacturing adenoviral vector-based vaccines.

  • Enabling Vaccine Production: Solving Challenges Together

    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. 

  • Droplet Digital Polymerase Chain Reaction

    Leveraging the hyper accuracy of Droplet Digital PCR (ddPCR), viral and gene therapy developers gain additional confidence in tittering assays and vector copy number determination.

  • Flow-Through Chromatography, Adsorptive Depth Filtration For Continuous Applications

    This paper examines adaptations to current technologies for downstream processing, such as clarification and chromatography, that facilitate more suitable conditions for continuous bioprocessing applications.