HOT PRODUCTS

• 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.

• ekko™ Acoustic Cell Processing System

  The ekko™ Cell Processing System is a true fit-for-purpose cell therapy manufacturing solution, employing acoustic technology and a multi-use platform to simplify cell therapy manufacturing. Its modular design improves flexibility and utilization while imparting minimal energy and stress for gentle handling of cells.

• Viresolve® Barrier Filters

  For effective bioreactor protection

• 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.

• 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.

• Bio4C™ ProcessPad

  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).

• Integritest® 5: Integrity Assurance With Ease And Confidence

  Accurately and reliably verify the integrity of your filters and processing equipment with the portable, easy to implement, and automated Integritest® 5. The Integritest® 5 delivers a simple and intuitive user experience, while providing optional depth of flexibility to fit your process.

• Series 4000™ Single Round Filter Housings

  New family of our housing portfolio designed to meet the demands of filtration process design. Series 4000™ housings have been designed in accordance with the life sciences industry’s demand for high-quality and cost-effective products. Our Series S4000™ housings are suitable for use in a wide range of applications with low dead volume, minimizing product loss and enhancing cleanability. The products are available in T-Line and In-Line configurations including the 5, 10 ,20, 30-inch sizes in Code 7.

• Mobius® Chrom 20 System

  The Mobius® Chrom 20 system is a flexible, automated, single-use chromatography system that enables consistent and reliable separation and purification of mAbs, vaccines, plasma, and therapeutic proteins at clinical and process scales.

• Natrix® Q Chromatography Membrane

  For single-use per batch biomolecule purification

  A high capacity, high throughput strong anion exchange chromatography membrane designed for single-use per batch biomolecule purification. The unique Natrix® Q membrane contains a high density of quaternary amine ligands that are directly polymerized within the porous membrane scaffold.

FEATURED ARTICLES

• Cell Therapy Manufacturing With The ekko™ System: DMSO Removal for Thawed Apheresis Material

  For CAR-T processes that require a freezing step between apheresis collection and manufacturing, it is critical upon thaw to remove Dimethyl sulfoxide (DMSO), a standard component of cryoprotectants, from the product to ensure the utmost cellular health of the apheresis material. In this application note, we demonstrate how the ekko™ Acoustic Cell Processing System consistently processes apheresis products.

• 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.

• Finding Fermentation Contaminants Faster With Fluorescence-Based Rapid Microbial Detection

  Traditional bioburden testing can take several days to show visible colonies. Earlier detection makes it possible to address fermentation contamination events sooner, avoiding reactor shutdowns and downstream problems. The Milliflex® Quantum system can quantitatively detect microbial contamination in filterable samples up to three times faster than traditional plate-based monitoring methods.

• Comparison Between Experimental Data And Computational Fluid Dynamics In Mixing Applications

  In biomanufacturing processes, mixing is ubiquitous and mixing trials are often necessary to assess if a technical solution is adapted for a given process step or to optimize process parameters. Discover how computational fluid dynamics can help in your mixing trials.

• Shaping The Future Of Formulation Development With Melt-Based 3D Printing Technologies

  In this white paper, the use of 3D printing to overcome challenges during formulation development is explored, with a focus on enhancement of bioavailability of active pharmaceutical ingredients (APIs) in solid dispersions. It is estimated that 60–70% of drug substances currently in clinical pipelines are categorized as Class II in the Biopharmaceuticals Classification System (BCS) which indicates low solubility. For an oral formulation, the proper API solubility is critical for absorption in the gastrointestinal tract. If solubility issues cannot be overcome during formulation development, an otherwise promising therapeutic candidate may have to be abandoned.

• Cell Culture Media Mixing And Microfiltration: Reducing Risk With Single-use Technology

  Cell culture media are complex mixtures of synthetic and biological components that provide the proper composition of nutrients for healthy cell propagation and high protein expression. Key concerns are to ensure product safety and purity. This paper presents our recommended methods for thoroughly mixing media, as well as reducing the risk of mycoplasma contamination.

• Plasmid DNA Downstream Process - For Gene Therapy And Plasmid-Based DNA Vaccine Development

  Widespread application of plasmid DNA (pDNA) in vaccines and gene therapy is driving increased demand. As a response, plasmid manufacturing must become more efficient with improved productivity. This process development guide provides you with guidance for your plasmid DNA downstream process development, including clarification, TFF, chromatography and sterile filtration unit operations.

• Performance Of High-Area Millipore Express® Cartridge Filters

  For minimizing filter footprint with improved filtration economics, sterilizing-grade filters that contain membranes in an M-pleat pattern offer maximum area density,  and a high level of device robustness.

• Sterile Filtration Of Ophthalmic Solutions

  Ophthalmic solutions are frequently sterile filtered. With the Millipore Express® SHF filters we have combined the benefits of low inherent preservative binding with high throughput.

• Demonstrating Millipore Express® SHR Mycoplasma Clearance

  Millipore Express® SHR filters are an option for biomanufacturers looking for a higher level of microbial risk reduction than sterilizing-grade filters. These filters contain a 0.1 μm polyethersulfone (PES) sterilizing membrane and are designed to efficiently remove mycoplasma contaminants from cell culture media.

• The Effect Of Mixing On Protein Using Mobius® Mixers

  To address broad biomanufacturing mixing applications, we offer two distinct lines of single-use mixers with common attributes. Depending on individual manufacturing set-ups and organizations, mixing equipment may have to be used without distinction for all applications. This application note explores the suitability of the different Mobius® mixer types for various model feeds.

• Development And Manufacturing Of A Fab Fragment For Clinical Trials

  In this customer case study, we are focusing on our collaboration with Acticor Biotech, a spin-off of Inserm, the French National Institute of Health and Medical Research, which is advancing an innovative drug for the treatment of the acute phase of ischemic stroke. Acticor selected MilliporeSigma’s BioReliance® End-to-End Solutions for process development and GMP manufacturing of a Fab fragment to support clinical trials. The project timeline allowed only 18 months to get from the cell line to clinical batch manufacturing.

• Setting The Stage For Electronic Data Exchange

  Digitization and automation, key elements of Bioprocessing 4.0, will be essential for this transformation, in which the industry will leave behind paper-based procedures, data silos, manual process control and equipment that cannot communicate with each other. Adoption of an electronic format for the exchange of data (referred to as eData) from suppliers of raw materials to biopharmaceutical manufacturers is an important step towards making Bioprocessing 4.0 a reality.

• Eshmuno® CMX Resin: Highly Selective Mixed Mode Chromatography Resin

  Are you interested in reducing the costs of chromatography steps? Unlock potential savings and achieve process excellence with Eshmuno® CMX chromatography resin.

• Avoid Surprises With Comprehensive Cell Line Characterization

  Avoid surprises with comprehensive cell line characterization. Learn more about how cell line characterization is a key element of viral safety assurance and critical to preventing cell line contaminants from entering the manufacturing process.

• Implementation Of A Virus Barrier Media Filter Into Fed-Batch Bioprocesses

  Upstream bioprocesses are at particular risk of contamination from adventitious agents. Typical 0.1 μm filters used at this step protect bioreactors from bacteria and mycoplasma, but offer no protection from viral contaminations. This study reveiws a new polyethersulfone (PES) virus barrier filter, Viresolve® Barrier filter, which provides an efficient and easy way to protect bioprocesses from adventitious virus contamination.

• Upstream Virus Safety: Protect Your Bioreactor By Media Filtration

  Biopharmaceutical manufacturing processes involve a multilayered approach to microbial and virus testing to assure that the drug product is safe for human use. Various technologies have been employed to minimize this risk. One of these, filtration, is a point of use operation that is easy to implement in the upstream process. This poster summarizes the performance of a filter specifically developed for virus removal from chemically defined cell culture media.