Insights On Enterprise Solutions

  1. Implementing A Fully Single-Use, Integrated mAb Biosimilars Purification Platform For Next Generation Manufacturing

    Within the biopharmaceutical industry, there is a significant shift toward higher productivity processes resulting in improved economics without compromising robustness. Therefore, integrated continuous production technologies are of greatest interest. 

  2. Corynex Protein Expression: Simplifying Recombinant Protein Production

    The rise of biologics is having a dramatic impact on how physicians treat many serious and chronic illnesses. Pharmaceutical companies looking to add biologics to their pipelines must come up with innovative ways to approach drug development and cut the high costs associated with it. In this white paper, we review how the Corynex® Protein Expression System uses an extensive toolbox to improve the levels of protein secretion and overall success rate.

  3. Developing A New Biologic Drug: Regulatory Challenges And Considerations

    The journey from research lab to market is a long one, and most drug candidates do not make it. For those that do progress to market, there are many regulatory milestones and hurdles. Following are some tips to assist with up-front planning to prevent headaches down the road.

  4. Scaling A mAb Production Process To A Single-Use Platform

    The transfer of a monoclonal antibody production process between scales, often referred to as scale-up or scale-down, is a difficult task. This study reviews moving a monoclonal antibody production process from a microscale bioreactor to the Xcellerex XDR single-use platform.

  5. An Introduction To Single-Use Instrumentation

    Emerson's solutions such as embedded process analytical technology, single-use technology, and continuous manufacturing are becoming increasingly more popular with bioprocessing companies focused on data-driven manufacturing and reliability.

  6. Single Use Manufacturing Measurement And Control

    Michalle Adkins, Director, Life Sciences Consulting, demonstrates single use measurement and control devices and how they can be used to measure and controls in the bioprocessing industry today.

  7. Single Use Instrument Solutions For Life Science Batch Processing

    Michael Francis, Global Product Manager, demonstrates how single use pH, dissolved oxygen, and pressure sensors help life science customers solve critical instrumentation measurement challenges in the biopharma industry.

  8. S.U.B. Enhancements For High-Density Fed-Batch Cultures

    Improvements in single-use systems have allowed implementation of high-demand cultures in emerging bioprocess workflows, while progressive advances in media optimization and improved clone genetic selection have underscored the perceived performance limitations of single-use bioreactors (S.U.B.s). This study presents how strategic enhancements of Thermo Scientific™ HyPerforma™ S.U.B.s have revealed improvement in mixing and mass transfer performance compared to legacy S.U.B. designs.

  9. Enhanced Single-Use Bioreactor Performance For Scalable Vero Cell Culture On Microcarriers In Serum-Free Medium

    Adherent cell cultures, such as those with Vero cells, are often more challenging than their suspension-based counterparts with scale-up methods that require optimization of agitation and other operating parameters. This application note presents how Thermo Scientific™ HyPerforma™ Single-Use Bioreactors (S.U.B.s) can be enhanced for scaled-up growth of adherent cells on GE Healthcare Cytodex™ 1 microcarriers in serum-free medium, in culture volumes of 50 L, 250 L, and 500 L.

  10. Application Enhancements For The HyPerforma S.U.B.

    With many end users now demanding streamlined operations, high-density culture in fed-batch modes, even higher production by perfusion cultures, and contrastingly gentle operations required in microcarrier applications, standard S.U.B. offerings must keep pace with the ever-evolving needs of the bioprocessing industry. Read about recent enhancements that are helping keep up with these increasing demands.