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.
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.
This webinar explores how rapid methodologies are being used to not only accelerate this process, but also enhance quality by reducing testing complexity.
This webinar describes a number of topics in the areas of cell line characterization and bulk harvest testing for contaminants where new technical innovations are occurring. The regulatory response to these developments is also discussed.
The Viresolve® Barrier filter offers opportunities for efficient processing of cell culture media components to reduce the risk of bioreactor contamination.
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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.
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.
While demand for mAbs and other antibody-based biologics increases, so does pressure on the biopharmaceutical industry to accelerate development, improve flexibility and reduce costs all while sustaining or improving drug product Although the benefits of next generation processes are recognized, there are many options to consider and multiple pathways to success. This whitepaper explores several 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.
Selecting the right filter is the first step in reaping the benefits of today’s filters; optimizing their performance efficiency is key to maximizing the benefits for the lifetime of your process.
Next-generation bioprocessing is a step-by-step evolution already well underway as the pharma industry undergoes a paradigm shift toward continuous processing.
MilliporeSigma was commissioned to perform the technology transfer and optimization of bioprocess chemistry and associated analytical methods for the production of antibody-drug conjugate ADC-X.
Steps to ensure products are free from microbial contamination and achieve a sufficient level of risk mitigation against potential bioburden issues for these applications.
Connecting processes can be considered the next stage in evolution for biopharma manufacture, but how should companies approach the challenges?
Survey results from 30 US and European biomanufacturers who were interviewed to understand the likely future adoption of ‘Next Generation Bioprocessing’ for mAbs over the next 5-10 years.
Industry stakeholders are coming together to share knowledge and expertise, explore new processes, and advance a culture of innovation.
How ADC chemistry and manufacturing have evolved over the years, present the challenges this growth has created and describe how CDMOs are adapting to these changes to meet customer needs.
Regulatory approval of a biosimilar requires comprehensive knowledge of both the process and the molecule while process development with the end goal in mind will help to achieve a robust manufacturing process.
Learn more on how ADC processes can be proportionally scaled up with single-use equipment.
Additional applications of PVA for sustained release and solubility enhancement that address specific challenges in pharmaceutical formulations.
