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  • FAQ's: Regulated Films For Containment Solutions

    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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  • 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

  • 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.

  • Weathering The Storm Of Regulatory Compliance In Aseptic Manufacturing

    When the U.S. Food and Drug Administration (FDA) conducts an unscheduled inspection of your aseptic manufacturing process, it can hit with the fury of a New England nor’easter. But just as careful planning and forecasting help us safely ride out the storm, a best-practice control and monitoring system minimizes the danger of FDA noncompliance. By Alex Mello, Microtest

  • Measuring Cell Culture Performance For PharmaGrade MSX

    L-Methionine sulfoximine (MSX) inhibits the activity of glutamine synthetase (GS), an enzyme essential for the production of glutamine. MSX can be used as a media supplement to aid selection and amplification processes in recombinant mammalian cell lines that use GS as a selective marker. 

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Mix-Mode Chromatography Resin Mix-Mode Chromatography Resin

Mixed-mode chromatography resin is a top tier selection for the manipulation, purification and handling of molecules; providing an unmatched level of separation properties and resolution. The combination of cation exchange resin and metal affinity resin properties, allows multimodal chromatography to provide an access route for biomolecules to separate and the use of alternative chromatographic methods make these biomolecules seem homogenous.

HyPerforma™ Single-Use Fermentor (S.U.F.) HyPerforma™ Single-Use Fermentor (S.U.F.)

The S.U.F. is engineered for optimal oxygen mass transfer, mixing, and temperature control, and performs comparably to traditional stainless steel systems. Using traditional, fundamental engineering principles, scale-up and process development work is streamlined – offering you cost savings and efficiency. 

Biopharmaceutical Analytical Software: BioPAT® SIMCA-Online Biopharmaceutical Analytical Software: 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.


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.

 DoE Software Package: BioPAT® MODDE DoE Software Package: 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.

Realtime Oxygen & Carbon Dioxide Measurements: BioPAT® Xgas Realtime Oxygen & Carbon Dioxide Measurements: 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%.

Fermentation Sensors: BioPAT® Spectro Fermentation Sensors: 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.

Online Measurements For Bacterial Fermentation and Mammalian Cell Cultures: BioPAT® Fundalux® Online Measurements For Bacterial Fermentation and Mammalian Cell Cultures: 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.

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