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FEATURED ARTICLES

  • Gaining Greater Predictability, Control And Quality In Bioprocessing With Metabolic Biomarkers
    Gaining Greater Predictability, Control And Quality In Bioprocessing With Metabolic Biomarkers

    Biologics are an integral part of the landscape of current therapies as pipelines continue to fill with them. Due to their importance and this ever expanding pipeline, the demands continue to escalate due to cost pressure, competition, regulatory requirements, disposable systems, and biosimilars. To date, these demands arguably have primarily been met with empirical understanding. However, there is a critical need for new approaches, tools, and technologies to deliver deeper understanding beyond the empirical realm. By Dr. Kirk Beebe, Director of Application Science, Metabolon, Inc.

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WHITE PAPERS & CASE STUDIES

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PRODUCTS & SERVICES

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.

ProVance™ Prepacked Protein A Columns

ProVance™ Prepacked Protein A Columns

ProVance™ Protein A Columns are a portfolio of single campaign-use columns designed for GMP purification of monoclonal antibodies. Prepacked with Grace® Protein A resin and available in a range of sizes, these columns expedite purification steps and help improve overall downstream productivity. The columns come complete with a regulatory support file and since they are disposable, eliminate the need for tedious clean in place and column packing procedures. ProVance™ columns can give you a competitive advantage by reducing non-value added labor steps and allowing focus on more important downstream processing tasks.

Pharmaceutical Containment of Powders

Pharmaceutical Containment of Powders

Storage of pharmaceutical compounds is a function of the storage process and not a specific containment driven requirement per se. This is the case whether you are processing in a contained fashion or performing non-contained processing into open kegs with simple drum liners.

Single Use Biopharmaceutical Powder Handling Equipment

Single Use Biopharmaceutical Powder Handling Equipment

ILC Dover brings a unique history and skill set to the biopharmaceutical industry, particularly single use biopharmaceutical powder handling and containment equipment.

Water-For-Injection Quality Water (WFI)

Water-For-Injection Quality Water (WFI)

Water for Injection (WFI) Quality Water is the most suitable water available for producing cell culture media, reconstitution of biochemical reagents, and as a final rinse water for critical applications. WFI Quality Water meets both EP and USP grade specifications and is 0.1µm sterile filtered at time of fill.

Helium Integrity Testing (HIT™)

Helium Integrity Testing (HIT™)

In recent years, the biopharmaceutical industry has become increasingly dependent on single-use assemblies that incorporate flexible containers (plastic bags), complex tubing sets and other disposable subcomponents.

Integrity Bioprocess Vessels

Integrity Bioprocess Vessels

Integrity™ liquid storage vessels are suitable for all typical bioprocess liquid storage applications and are available in 2-D or 3-D bag configurations with sizes from 1L to 3,000L. Standard or custom connectivity options. The powder transfer vessels are suitable for powder storage and transfer applications such as media, buffers, and pharmaceutical ingredients. They are flexible, transparent, funnel-shaped bags with tri-clamp interfaces for broad process compatibility and contain an  Antistatic USP Class VI/ADCF film for safe, contained powder handling and high material recovery.

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