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.

CONTACT INFORMATION

MilliporeSigma

400 Summit Drive

Burlington, MA 01803

UNITED STATES

Phone: 1-800-645-5476

HOT PRODUCTS

  • Bio4C™ Orchestrator connects to individual unit operations from a centralized “orchestration layer” for complete visibility, monitoring, and management of regulatory-compliant biomanufacturing systems and processes. Bio4C™ Orchestrator’s consolidated control optimizes processes improving quality and compliance while reducing human errors and operating costs.

  • To ensure optimum equipment uptime and regulatory compliance while mitigating risks, MilliporeSigma has developed System Service Reliance Plans; a complete range of services for your systems and equipment. These comprehensive service and support packages allow you to select a coverage level that best fits our needs. The Essential Reliance Plan includes a selection of preventive maintenance and troubleshooting services while the Advanced Reliance Plan provides higher coverage, with faster response time and priority access to remote and on-site support. All services are performed by MilliporeSigma’s global experts who have intimate knowledge of the equipment, backed by decades of experience.

  • MilliporeSigma’s Mobius® single-use mixing solutions deliver advanced technology for mixing pharmaceutical ingredients from intermediate to final drug products and for the preparation of process solutions, such as buffers and media. Unlike traditional stainless-steel mixers, single-use mixers reduce downtime due to CIP, SIP, cleaning validation, and process engineering. Mobius® single-use mixing solutions also offer operational flexibility as they can be up and running in less than five minutes. They are capable of mixing speeds up to 1000 RPMs meeting the broadest range of mixing production requirements. Mobius® flexibility offers you a choice of just the right filter, connector, tubing options for your specific application and environment, including sterile interfaces, from fermentation to final fill. Sizes range from 10 L to 3000 L.

  • You’re developing lifesaving gene-modified cell therapies and need to manufacture lentiviral vector as quickly as possible. But scale-up and regulatory hurdles make the path to the clinic slow and labor intensive.

    We're here to help.

  • 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.

  • Cell culture media are important for process efficiency and mAb quality. Production media support initial cell growth and production, while the feeds replenish depleted nutrients required for cellular function and maintain and extend the production phase in fed-batch mode.

  • 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.

  • In recent years, the development of media used to expand and mature adult stem cells has greatly increased the success rate of adult stem cell therapy and the breadth of potential stem cell-based therapies. To obtain enough cells, ex vivo expansion has been utilized to ensure successful engraftment and economize the manufacture of both allogeneic and autologous therapies.

  • Bio4C™ ProcessPad software is a data collection, visualization, and analytics software platform that facilitates 21 CFR Part 11 compliance and enables bioprocess monitoring, lifecycle management, reporting, investigations, and continued process verification (CPV).

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

     

FEATURED ARTICLES

  • This poster reviews two virus-based gene delivery platforms – adenoassociated virus (AAV) and lentivirus (LV) – focusing on the development, validation, and implementation of titration methods used to measure functional titer.

  • Explores how safety and characterization testing of viral vector production differs from that of other biologics and how novel analytical approaches are being tailored to these advanced therapeutics.

  • Rapid testing methods for sterility, mycoplasma, and replication competent lentivirus of cell and gene therapies can help address critical issues within this rapidly growing area of the market.

  • Assurance of viral clearance can be difficult, however, during production of vectors such as adeno-associated viruses (AAV) used for the purpose of gene delivery. The need to define and deploy an appropriate and robust viral clearance strategy can be particularly challenging without an overarching strategy in place.

  • Existing upstream equipment and/or facility infrastructure can present an impediment to intensification efforts and consequently limit gains in efficiency. This application note describes how N-1 perfusion using an expansion medium supports inoculation of a fed-batch, production bioreactor at a much higher cell density resulting in increased product titers.

  • Protein viscosity is one of the major obstacles in preparing highly concentrated protein formulations suitable for subcutaneous injection. This whitepaper examines how combining an amino acid with a second viscosity-reducing excipient circumvents adverse effects on protein stability and improves viscosity-reducing capacity.

  • Vectored vaccines show promise in their reliability to induce potent cell-mediated immunity. This paper describes a template to manufacture an adenovirus-based vaccine.

  • The manufacturing process for each viral vaccine is dictated by shape, size, nature, physico-chemical behavior, stability, and host specificity. This paper reviews steps in these manufacturing processes.

  • Cell culture processes are complex and highly variable and yet only a handful of key parameters such as temperature, pH, and dissolved oxygen (DO) are typically controlled in real time. These parameters do not provide a direct indication of the culture content itself; instead, they provide only broad assumptions on the culture’s true state and offer limited insights into the process and cell growth. Here we describe the use of the Procellics™ Raman Analyzer with Bio4C™ PAT Raman Software to perform in-line and real-time measurement of TCD, VCD and the concentration of glucose, lactate and ammonium in a bench-scale bioreactor.

  • For a biopharmaceutical formulation to be safe and effective, it’s critical that the therapeutic protein is chemically and physically stable.  Degradation of the protein, such as by aggregation, would result in a loss of pharmacological activity and possibly trigger adverse effects. Here we take a closer look at how nanoparticles affect protein formulation and what can be done to prevent nanoparticle-induced instabilities.

  • This application note describes the use of Procellics™ Raman Analyzer with Bio4C™ PAT Raman Software to monitor glucose levels in a bioreactor and trigger automated addition of feed to maintain the desired concentration.

  • Raman spectroscopy is an accepted Process Analytical Technology (PAT) tool in the biopharmaceutical industry. There are many advantages to implement in-line Raman analysis including reducing costs, optimizing feed strategies, and improving bioprocess understanding. However, the industry has encountered some obstacles in the implementation of Raman monitoring as a PAT tool. This poster illustrates solutions to overcome these issues, especially how to save time when implementing Raman spectroscopy in a cell culture application.

  • In vaccine and viral vector production, impurity clearance is an essential purification step and required for drug approval as residual impurities may impact patient safety. A critical step in the purification process is reduction in the size and quantity of extracellular nucleic acids by endonuclease enzymes. This application note summarizes the benefits of incorporating Benzonase® endonuclease in a polio virus type 3 production process.

  • Biopharmaceutical manufacturers are leveraging several approaches to intensify processes with a goal of improving efficiency and productivity and reducing costs — all while ensuring the highest quality standards. The upstream workflow offers several opportunities to apply next generation technologies and methods to achieve these important goals. In this white paper we discuss integration of high cell density cryopreservation (HCDC) in the seed train and explore key considerations for developing a cryopreservation process including choice of cryoprotectant and freezing techniques.

  • MilliporeSigma has developed a wide range of solutions to facilitate the delivery of gene therapy by addressing the challenges related to viral vector manufacture and scale-up.

  • Millipak® Barrier and Millidisk®  Barrier filters contain hydrophilic and hydrophobic sterilizing-grade Durapore® 0.22 μm membrane. As they allow the passage of both liquid and air, they can be used to simplify wetting and drying during integrity testing of sterilizing filters. Learn more about the benefits of these filters and some guidance for implementation.

  • Strong anion exchange (AEX) chromatography has become an industry standard in polishing steps for monoclonal antibody (MAb) purification. It is a proven technology to remove DNA, viruses, endotoxins and acidic host cell proteins (HCP) from process feed streams in flowthrough mode. This application note examines the performance of Natrix® Q chromatography membrane in comparison to currently available quaternary amine resins, membranes and salt-tolerant primary amine membranes.

  • MilliporeSigma’s new cell culture medium offers an improved alternative to classical formulations that can help address the constraints in viral vector manufacturing and scale-up.

  • Single-pass tangential flow filtration (SPTFF) can be used to achieve higher final concentrations, optimize product recovery, control volume of intermediate steps, and enable intensified or continuous processing with chromatography or filtration operations. This study demonstrates efficient cleaning strategies to enable multiple reuse of TFF cassettes for high concentration applications with SPTFF.

  • Lack of consistency in cell culture media can create significant variation in your upstream process. To control cell culture media variability and ensure the quality of our products worldwide we have implemented a robust supply process that incorporates a global raw material and vendor management program, a consistent manufacturing network, and global quality systems.