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WHITE PAPERS & CASE STUDIES

  • Continuous Biomanufacturing: 10 Reasons Sponsors Hesitate
    Continuous Biomanufacturing: 10 Reasons Sponsors Hesitate

    By William Whitford, Sr. Manager, HyClone Cell Culture, GE Healthcare

    The industry is abuzz with talk about continuous biomanufacturing (CB), and it virtues have been well described. Here we will look at some of the barriers or concerns perceived to limit its value to the industry. Justified or not, quite a few concerns have been expressed regarding the implementation of this new, rather disruptive technology. 

  • Precise Cold-Chain Logistics Supports Global Study Of Heart Disease
    Precise Cold-Chain Logistics Supports Global Study Of Heart Disease

    The challenge involved the precise cold storage temperatures (between 2-8°C) required to assure the integrity of the strips during the transfer and storage of the product to various sites around the globe.

  • Process For Scale-Up Of Adherent Vero Cells From Static Cell Factories To Influenza Production

    In cell culture-based vaccine production, scale-up of adherent cells is challenging. This study shows a process for scaling up adherent Vero cells from static cell factories to influenza production at 50 L scale using WAVE Bioreactor™ systems and ReadyToProcess single-use equipment.

  • A Comparison Of Performance Using Three Bioreactor Systems
    A Comparison Of Performance Using Three Bioreactor Systems

    Eppendorf has introduced a new benchtop cell culture bioreactor that combines the benefits of single-use technology with the trusted performance and true scalability of a stirred-tank design. CelliGen™ BLU eliminates the need for autoclaving and cleaning, reduces validation requirements, provides rapid turn-around between runs, minimizes startup costs, and significantly reduces the risk of contamination because the culture vessel is only used once and then discarded.

  • Maintain The Benefits Of Single-Use Technology With Cell Culture Processing
    Maintain The Benefits Of Single-Use Technology With Cell Culture Processing

    Historically, stirred-tank bioreactors have been the standard for culturing all types of submerged cultures including suspension and anchorage-dependent mammalian, insect, yeast, plant and microbial cultures. By Nick Kohlstrom, Joseph Capone, and Ma Sha, Eppendorf Inc.

  • Latin America Emerges As World Competitor For Global Trials Despite Tough Regulatory Environment
    Latin America Emerges As World Competitor For Global Trials Despite Tough Regulatory Environment

    The challenge to managing trials in Latin America lies in its a highly regulated drug development environment. Independent regulatory bodies, local health ministries, their supporting agencies, and ethics committees mandated to ensure patient safety currently slow down the regulatory approval process. By World Courier

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PRODUCTS & SERVICES

Logistics Audit/Assessment & Engineering Solution Services

Modality Solutions provides services such as: cGMP readiness assessments, product characterization and stability studies for distribution, controlled-environment logistics process validation, quality management systems and change control, and thermal packaging design and qualification.

Integrity Mixers

Integrity Mixers

Integrity™ branded products are made from the same TK8 film so all product-contact areas are identical. This approach simplifies qualification and validation efforts and reduces overall costs. ATMI's Integrity Mixing Systems have the broadest range of flexible, single-use mixing systems. They can contain solid/liquid  and liquid/liquid mixing solutions with mixing volumes scalable up to 2000L. The single-use systems eliminate non-value-added cleaning and eliminate cross-contamination risk.

Integrity Bioreactors

Integrity Bioreactors

Integrity™ Bioreactors are scalable, ergonomic and modular systems with very low shear mixing. Integrity Bioreactors keep control of all process parameters ensuring customized culture conditions, and they are carefully adapted for cultivation of suspension and adherent cells at very high densities. There is no need for CIP/SIP, and can help avoid cross-contamination risks. Integrity™ branded products are made from the same TK8 film so all product-contact areas are identical. This approach simplifies qualification and validation efforts and reduces overall costs.

Newform, Medical Grade Packaging

Newform, Medical Grade Packaging

In the fast growing Biopharma market, the need for ultra clean sterile packaging is growing at a high speed, often driven by regulatory authorities and cGMP regulations.

Eliminating every risk of delivering a contaminated parenteral drug that might be hazardous to a patient's health or even his life is the key concern that drives these regulations. With our Newform™ product line, we respond to this need by producing cleanroom packaging that meets these ever growing requirements.

Pall® XRS 20 Single-Use Bioreactor System

Pall® XRS 20 Single-Use Bioreactor System

The XRS 20 Bioreactor System is a new single-use bioreactor system with unique agitation and control properties designed for the cultivation of mammalian cells in suspension culture under controlled conditions and suitable for applications ranging from general life sciences research to seed train operations and full GMP production at the 2 to 20 liter scale.

SciLog Automated Bioprocessing Systems

SciLog Automated Bioprocessing Systems

Parker domnick hunter bioprocessing filtration solutions are available as part of an integrated single-use system reducing capital costs, footprint and validation of cleaning regimes. Our products are aimed to minimize the potential risk and maintain flexibility as product development moves from R&D to full commercial production. We integrate currently validated components into a fully validated and ready-to-use system solution.

SciPure™ TFF and NFF Systems:  Ideal For GMP Manufacturing

SciPure™ TFF and NFF Systems: Ideal For GMP Manufacturing

Accelerate to market and reduce your purification costs with SciLog’s SciPure™ TFF and NFF Systems.

Single-Use And Ready-To-Use Biopharmaceutical Products

Single-Use And Ready-To-Use Biopharmaceutical Products

Biopharmaceutical development and manufacturing demands scalable processes that can be quickly developed and smoothly transferred to production. GE Healthcare Life Sciences’ single-use and ready-to-use technologies, ReadyToProcess™ and Xcellerex™, play a crucial role in providing the flexibility to support multi-product facilities. They deliver process time savings by removing steps such as cleaning, cleaning-validation, filter prewashing and column packing, allowing faster start-up and easier changeover between products.

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