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

  • 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

  • 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

    There are significant consequences associated with microbial contamination during biopharmaceutical manufacturing. Sampling of biopharmaceutical process intermediates and the final product is essential for manufacturing workflows where the final product cannot be terminally sterilized. This whitepaper provides a summary of regulatory guidelines for sampling, describes the traditional methods available for sampling and their limitations, and explores the advantages of aseptic, single-use sampling and how this approach more effectively aligns with regulatory guidelines.

  • Hiring Challenges In Bioprocessing For Start-Ups

    Hiring of bioprocessing professionals has remained a stubborn problem over the past 11 years, and will only get worse. This can benefit experienced staff seeking career advancement while creating a challenge for start-up companies as the supply of qualified staff gets tighter. Read how the industry could alleviate this problem.

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

    As an early-stage or small-sized biotech company, you need to move fast and be nimble. The key to success is understanding that while the fastest path is often tempting, the right path is to ensure product quality and viability while expediting the development timeline. And sometimes, predicting which path will be most successful for your molecule requires serious strategic thinking and experience in key areas.

  • 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

    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.

  • 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.

  • 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.

  • 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.