HOT PRODUCTS

• Bio4C™ Orchestrator Software

  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.

• Ensure Optimum Equipment Uptime With System Service Reliance Plans

  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.

• Integrated Mixing And Filtration Solution for Economic And Processing Flexibility

  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.

• VirusExpress™ Lentivirus Production Platform

  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.

• 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.

• 4CHO Fed-batch Media And Feeds

  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® 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.

• Stemline® Stem Cell Culture Media

  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

  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).

• Cellicon™ Perfusion Filter And Controller

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

   

FEATURED ARTICLES

• Unlocking The Potential Of Viral Vectors Through Functional Titer Assays

  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.

• Envisioning The Future Of Analytical Development For Gene Therapies

  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.

• Implementation Of Rapid Test Methods In Cell And Gene Therapy Testing

  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.

• A Multifaceted Strategy For Viral Safety In AAV Processes

  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.

• Preparing CHO Cells For Higher Productivity By Optimizing A Perfused Seed Train

  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.

• Protecting Protein Stability With A Novel Grade Of Sucrose

  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.

• Viral Vector Vaccine Bioprocessing Handbook

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

• Virus-Based Vaccine Bioprocessing Handbook

  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.

• In-Line Real-Time Monitoring Of CHO Cell Culture Process Parameters Using Raman Spectroscopy

  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.

• Securing Protein Stability With Low-NPI Sucrose

  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.

• Joint Application Note: Seamless Integration Of Glucose Control Using Raman Spectroscopy In CHO Cell Culture

  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.

• Scale Down Approach For Faster Implementation Of Raman Monitoring Of Upstream Cell Culture Processes

  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.

• Effect Of Benzonase® Endonuclease Addition To Purification Of Sabin Polio Virus Type 3

  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.

• Guidelines For Developing A High Cell Density Cryopreservation 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.

• Addressing The Challenge Of Scalability In Viral Vectors

  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.

• How Millipak® Barrier And Millidisk® Barrier Filters Streamline Final Sterile Filtration

  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.

• Natrix® Q Chromatography Membrane

  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.

• Optimized Cell Culture Medium For Scalable Viral Vector Production

  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.

• Pellicon® 3 Cassettes Cleaning Methodology For Reuse In Single-Pass Tangential Flow Filtration Mode

  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.

• Cell Culture Media Supply Robustness And Control

  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.