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:
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.
Novel viral therapies are emerging and gaining more interest after recent regulatory approval of CAR-T and AAV based gene therapies. While no viral contamination has been reported so far for these therapies, it is important to learn from historical experience and leverage improved manufacturing and testing methods to increase their safety. This would help avoid product supply and patient treatment disruptions as well as protect the company’s business and reputation. In this webinar we will highlight the biosafety challenges associated with the manufacture of viral vectors and how a holistic risk mitigation approach can reduce contamination events.
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.
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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.
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.
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.
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?
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.
The next generation parvovirus safety solution designed to provide the highest levels of retention assurance and productivity.
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.
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.
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.
HCDC, an alternative to the traditional method for seed train expansion, can jump-start a manufacturing campaign by several weeks, removing a large part of the seed train from the critical path to production.
The biopharmaceutical industry is beginning to take the necessary measures to improve the efficiency of monoclonal antibodies. Learn more about how the adoption of single-use technologies is a key strategy for delivering higher productivity and enabling more flexible manufacturing processes.
In the early days of the biopharmaceutical industry facilities used inflexible, hard-piped equipment and stainless steel bioreactors and tanks. More recently, single-use technologies have emerged, presenting an attractive alternative that allows companies to eliminate cleaning validation requirements, while reducing the risk of cross contamination. Single-pass TFF is a convenient means of reducing volumes, column sizes and hardware costs, as well as eliminating tank bottlenecks – and can be powerfully combined with single-use technology.
There are a number of different ways of describing next generation bioprocessing, including continuous manufacturing and intensified processing. This article examines how biopharmaceutical process development be affected by next-generation technologies.
Although many new treatment modalities are emerging, monoclonal antibodies (mAbs) remain dominant in late development pipelines. Thanks to the emergence of intensified and connected processes, the path to continuous biopharma manufacturing is open.
While upstream titers have improved dramatically over the last decade, downstream processing has remained relatively unchanged. Now is the time to push bioprocess efficiencies even further. In August 2017, MilliporeSigma acquired Natrix Separations, Inc., a provider of hydrogel membrane products for single-use chromatography. Renaud Jacquemart has been with Natrix since 2011 and was former Director of Vaccines Process Sciences. Here, he explains how the Natrix® technology could offer a helping hand in next generation bioprocessing.
This poster compares three tentacular strong cation exchange (CEX) resins, Eshmuno® CP-FT resin, Eshmuno® CPX resin and Eshmuno® CPS resin. While they share a common base bead, they differ significantly in both their ligand density and tentacle structure based on their use for different applications.
This eBook is an overview of applications and technologies leading the way to next generation biomanufacturing.
Companies are moving from stainless steel to single-use assemblies for final filtration allowing them to meet production demands and cut costs. The design of single-use assemblies can be challenging. Learn more about the different options that should be considered to accommodate pre-use integrity testing along with prototype testing and handling considerations.
Demand for mAbs creates pressure to accelerate development, improve flexibility, and reduce costs while sustaining or improving drugs.This paper explores upstream strategies to increase protein titers, which can translate into higher throughput, improved flexibility, and compressed timelines.
The preparation of media for use in biopharmaceutical processes can be complex and may carry risks that must be identified, assessed and mitigated to assure consistency of performance and minimize likelihood of contamination. Without the proper risk mitigation, problems can arise which may ultimately compromise product quality, shutdown production or potentially impact patient safety. This whitepaper describes considerations for selecting a vendor to support your media preparation workflow, and will discuss approaches to minimize variability and de-risk steps.
Biomanufacturers seeking a place in a competitive and lucrative future must start engaging in change now to meet the demands for delivering drugs more quickly to the patients who need them.
Bioburden control is an integral component of every biologics production process. Determining the appropriate bioburden control strategy can be challenging given the many different technologies available for today’s biologics manufacturers. In this eBook, we provide information to highlight the differing objectives for bioburden control by unit operation and discuss the parameters that guide filter selection and optimization. In addition, we focus on industry trends toward intensified processing and increased implementation of single-use systems, and how they are changing expectations for sterile filtration and bioburden control.
To help meet the needs of both large- and small-scale operations, suppliers of sterilizing-grade filters have developed new products and technologies to help meet the needs of today’s biomanufacturing processes. Industry trends toward intensified processing and increased implementation of single-use systems are changing approaches to sterile filtration and bioburden control in biomanufacturing processes.
Understanding the different considerations for bioburden control in various operations and production steps can help define a strategy for successful production.
Membrane-based prefilters are used to limit the variability of process streams by removing plugging contaminants thereby protecting sterilizing-grade filters and other unit operations.
Sterile filtration of liquids is vital to minimizing microbial contamination and ensuring product safety and integrity. Understanding the criteria for optimum filtering helps streamline product selection.
