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FEATURED ARTICLES

  • ArmorFlex® 110 Film Frequently Asked Questions

    At ILC Dover, we are always "creating what’s next" by listening carefully to our customers. In response to customer input and emerging regulations, we've developed a robust new film to support our DoverPac® Containment Solutions line. This revolutionary product, ArmorFlex® 110, delivers permanent static dissipative properties while meeting FDA and 2002/72/EC requirements for food contact.

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WHITE PAPERS & CASE STUDIES

  • Options For Shortening Integrity Test Time Of Sterile Filters
    Options For Shortening Integrity Test Time Of Sterile Filters

    The integrity testing of sterile filters constitutes a critical and mandatory regulatory step in biopharmaceutical production processes.

  • Important Considerations For Implementing A Single-Use Biomanufacturing Strategy
    Important Considerations For Implementing A Single-Use Biomanufacturing Strategy

    Recent trends in biomanufacturing technology and the biopharmaceutical market are supporting the increased adoption of single-use (SU) manufacturing systems. On the demand-side, the biopharma industry is focusing on niche and rare diseases with smaller patient populations, resulting in the need for smaller, more agile biomanufacturing capacity. By Jodi M. Zobrist and Nicole W. O'Brien, Ph. D., Gallus Biopharmaceuticals, LLC

  • Automated pH Adjustment In An Intelligent Single-Use Mixing Platform
    Automated pH Adjustment In An Intelligent Single-Use Mixing Platform

    Most pH adjustment process steps in single-use biomanufacturing require manual manipulation of the product and vessel, including off-line sampling, pH measurement, and the addition of acid and base.

  • Inside BioPharma: A Closer Look At Filter Housings
    Inside BioPharma: A Closer Look At Filter Housings

    Although traditional stainless steel equipment has lost a great deal of market penetration to single-use alternatives over the past decade, there still is a need for quality filter cartridge systems for sterilizing and polishing filtration processes. By Leon VanWormer, MBA, Sartorius Stedim Biotech

  • Peristaltic Aseptic Filling Machines With A Single Use Production Philosophy
    Peristaltic Aseptic Filling Machines With A Single Use Production Philosophy

    New drug development is today focused largely on biopharmaceuticals rather than chemicals, which means that the resultant drugs tend to be injectable liquids instead of solids. Furthermore, the new drugs are typically designed for specific populations, hence batch sizes are smaller. Alongside these two trends there are ongoing pressures to increase efficiency, reduce costs, and minimize risks — including cross-contamination between batches. Additionally there is a need for a reduction in the time involved in validation procedures; paperwork and man-hours, for example. Taken together, these factors point towards peristaltic pumps with single-use tubing or tubing sets as representing the future for bio-pharmaceutical fill/finish lines. By Peter Lambert

  • Meeting BioPharma Needs For Lower Operating Cost And Faster Time To Market

    Broad adoption awaits fully scalable GMP systems, improved and less costly disposables, better analytics, greater process automation and low-shear mixing.

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PRODUCTS & SERVICES

BioPAT® SIMCA-Online

BioPAT® SIMCA-Online

Continuous real-time quality control and assurance is a highly desired state in biopharmaceutical manufacturing, which can be achieved by sophisticated process control strategies that use multivariate monitoring techniques to prevent or mitigate the risk of producing a poor quality product.

BioPAT® SIMCA

BioPAT® SIMCA

Multivariate Data Analysis (MVDA) techniques are being increasingly used for scale and batch-to-batch comparison investigations to support or derive process understanding and to ultimately improve the quality, safety and efficacy of a drug product.

BioPAT® MODDE

BioPAT® MODDE

BioPAT® MODDE is a state-of-the-art DoE software package that is used by scientists, engineers and statisticians alike to help understand complex processes and products.

BioPAT® Xgas

BioPAT® Xgas

With the BioPAT® Xgas, you can monitor and control bioprocesses in real time. The BioPAT® Xgas is a combined oxygen-carbon dioxide sensor featuring automatic compensation of humidity and pressure. The oxygen concentration can be measured in a range of 1 – 50% and the carbon dioxide concentration in a range of 0 – 10%.

BioPAT® Spectro

BioPAT® Spectro

BioPAT® Spectro NIR process sensor monitors the fermentation process inline by providing real-time feedback. Monitoring the process values during biotechnological fermentation is crucial for maintaining the high efficiency and quality of a bioprocess.

BioPAT® Fundalux®

BioPAT® Fundalux®

BioPAT® Fundalux – For online measurement of turbidity and total biomass in bacterial fermentation and mammalian cell cultures.  Designed for use in R&D, as well as in pilot- and production-scale..  Can be used for online triggering of control loops for advanced automated fermentation.

Emphaze™ AEX Hybrid Purifier

Emphaze™ AEX Hybrid Purifier

The Emphaze Hybrid Purifier is a new single-use clarifying device containing a multi-mechanism all synthetic Q-functional anion exchange media integrated with a fine particle, bioburden reduction membrane. The anion exchange media is comprised of a quaternary amine hydrogel supported by a fine fiber nonwoven scaffold. A combination of 3M technology platforms enables the hyperfunctionalization of a high purity polypropylene nonwoven with a covalently attached, thermally stable, water soluble polymer; the functional polymer accounts for roughly two-thirds of the mass of the anion exchange media. The bioburden reduction membrane is a highly asymmetric, high loading capacity polyamide membrane which has nine zones of decreasing pore size spanning a roughly 20X range and terminating with a 0.2 μm bioburden reduction rated pore size.

Flexsafe Single-Use Bags

Flexsafe Single-Use Bags

Standard Flexsafe 2D validation bags made of the new polyethylene S80 film are designed for small scale investigations and for the validation of the Flexsafe bag family. They are available in 150 mL and 500 mL volumes to support end users’ process development and validation testing. Flexsafe bags have been designed by combining material science and a Quality by Design approach to provide outstanding cell growth, robustness and assurance of supply for all process steps of biomanufacture.

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