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

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. 

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.

Within the biopharmaceutical industry, there is a significant shift toward higher productivity processes resulting in improved economics without compromising robustness. Therefore, integrated continuous production technologies are of greatest interest. 

As the industry is looking to increase speed to market, reduce manufacturing resources and increase product safety, there has been a push to implement single-use technologies. Combining both SPTFF and single-use technology can be a powerful tool for the efficient manufacture of biologics.

Where sterility will be claimed, regulatory agencies worldwide require that the integrity of sterilizing-grade filter(s) is verified before and after use to ensure filter performance. This webinar highlights best practices and key considerations for performing filter integrity tests to give you a better understanding of how to design a robust integrity test operation in your own facility.

Understanding the source, options for control, and potential impact of bioburden throughout downstream biopharmaceutical processes is beneficial to process developers, production operators and pharmaceutical microbiologists. Process designs that reduce the risks of bioburden contamination will decrease process related failures and the resulting painful, time-consuming investigations.

In this webinar a M-pleat pattern is demonstrated to provide up to 100% more membrane area than a conventional pleat pattern.

Parvovirus retentive filters are a commonly implemented and validated viral clearance technology within bioprocesses (mAb/recombinant and plasma fractionation). Regulatory guidance stresses that viral clearance filter validations be as representative of full scale manufacturing as possible to ensure the validity of the study results. There are a number of critical factors to consider during validation which can present challenges in maintaining this representativeness. If these factors are not properly addressed in the study design, retention and/or capacity could be negatively impacted.

Having challenges optimizing your virus clearance filter capacity and flux? Join us for our upcoming webinar to learn how prefiltration technologies can provide significant increases in the performance of your viral clearance filter.

This presentation covers points to consider for successful tech transfers, and includes lessons learned from real cases.

CONTACT INFORMATION

MilliporeSigma

290 Concord Road

Billerica, MA 01821

UNITED STATES

Phone: 781-533-6000

HOT PRODUCTS

  • 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.

  • Biodevelopment Services: From Molecule To Commercial Production

    Are you looking to expand the production of your recombinant proteins, vaccines or plasma commercial drugs? Do you need to bring affordable biosimilars to emerging markets?

  • 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

  • Designing Quality Into Chromatography Resins To Minimize Variability

    Chromatography resins and adsorptive membranes occupy a central role in the downstream purification of biologics and as such, the raw materials and processes used to manufacture these materials directly impact their performance. Assurance of quality and lot-to-lot consistency begins at the earliest stages of the research and process development phases, when new resins and membranes are being conceptualized and designed to meet the evolving needs of our customers. 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

    The use of animal models for the detection of adventitious agents has been a feature of biologic testing packages for many decades. However, as alternative methods such as PCR and NGS have emerged these in vivo tests have stubbornly remained a central part of testing. Here we examine the current in vivo methods and explore alternatives which can be employed today.

  • Strengthening Your Chromatography Resin Supply Chain By Increasing Transparency And Control

    This white paper explores key components of our chromatography resin supply chain program which help customers control their supply chains as they seek to ensure steady progress towards their next milestone and consistent availability of medicines for patients in need.

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

    Every biopharma executive must make important decisions early in clinical development that will impact their molecule’s journey – and ultimately the success of their commercial strategy. In this guidebook, the experts share some key considerations to help biopharmaceutical companies successfully advance a molecule from the laboratory to the clinic as quickly as possible without sacrificing product quality, process efficiency, or 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.

  • Perfusion - Design Of A High-Density Cell Culture Medium And The Positive Impact On Upstream Productivity And Economics

    Perfusion-based upstream processes can address the need to attain higher volumetric productivity from upstream processes.by delivering higher volumetric productivities, increased flexibility and accelerate time to market. This white paper describes the development and testing of a cell culture media designed for use in perfusion processes.

  • 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 And Data Management Approaches For Today’s 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 Helps To Overcome Vaccine Process Challenges

    Due to the sheer number and diversity of today’s promising vaccine types, and many competing cell culture, production and purification options that are available, development of large-scale vaccine production process remains an inherently
    challenging undertaking. This white paper showcases collaborative technology-development efforts carried out by the DiViNe consortium to advance the use of an innovative affinity chromatography platform during vaccine manufacturing. This paper also discusses how long-term partnerships with strategic technology experts can help overcome inherent issues that arise as promising vaccine candidates move through scaleup, from proof-of-concept through commercial-scale manufacturing.

  • Developing An Accelerated And More Cost-Effective Single-Use Adenoviral Vector Vaccine Manufacturing Process Through Public-Private Collaboration

    while remarkable progress has been made in eradicating devastating diseases such as smallpox and polio, the global population remains at risk due to difficulties accessing vaccines, shortages in supply, slow responses to outbreaks and pandemics and the presence of emerging pathogens. In this whitepaper, we describe our collaboration with the Jenner Institute, Oxford University in the United Kingdom to develop an optimized, single-use GMP process for manufacturing adenoviral vector-based vaccines.

  • Enabling Vaccine Production: Solving Challenges Together

    The constant threat posed by these pathogens drives demand for effective, safe and affordable vaccines. Unfortunately, the complexity and variety of vaccine types and manufacturing methods have prevented establishment of robust processing templates, which can leave vaccine manufacturers on their own to develop customized approaches for each pathogen and each outbreak. This eBook contains a series of case studies highlighting our recent collaborations with organizations and thought leaders on the front lines of the battle against these challenging pathogens. I know you will be inspired by these initiatives and I encourage you to contact us to explore new ways to tackle this problem, together.

  • 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.

  • Next Generation Bioprocessing And The Implications For Viral Safety

    With many companies embracing the move to next generation biopocessing, it is important that they do not forget to re-examine their approach to viral safety.

  • The Holistic Approach To Upstream Viral Safety

    Given that upstream processes are complex, multiple strategies and technologies must be integrated within a holistic viral contamination risk management program.

  • A Biosafety Revolution

    Biopharma manufacturers have been using the same assays for viral safety testing for decades, but new analytical technologies and molecular approaches offer a faster and more reliable approach.

  • Streamlining Buffer Management To Enable Facility Flexibility

    Improving efficiency in buffer delivery is an important part of meeting the goals of Biophorum’s road map for the future, which could be a critical strategy in increasing productivity and decreasing costs.

  • Next Generation Processing: An Evolutionary Journey Across Many Disciplines

    While the benefits of next generation bioprocessing are clear, there are multiple pathways to success and many options across a range of disciplines must be considered. See how the the BioContinuum™ Platform provides the building blocks to help you achieve your specific bioprocessing goals.

  • Intensified Seed Train: Driving Value Towards The Evolution Of Upstream Processes

    Perfusion involves the constant feeding of fresh media and removal of spent media and product while retaining high numbers of viable cells within the bioreactor vessel. With the increased pressure to drive down manufacturing costs and to improve facility flexibility, there is a need to implement new perfusion-based approaches.

  • Neglected Tropical Diseases — Improving The Manufacturing Paradigm For A Novel Recombinant Protein Vaccine

    Working in close partnership, Texas Children’s Hospital Center for Vaccine Development at Baylor College of Medicine, and MilliporeSigma, the life science business of Merck KGaA, Darmstadt, Germany, are combining their bioprocess and engineering expertise to advance and optimize the manufacturing process for a promising new preventive recombinant proteinbased vaccine, to end the scourge of Schistosomiasis, one of the world’s most devastating and pervasive parasitic infections and neglected tropical diseases.