Insights On Upstream Manufacturing

  1. Development Of An Intensified Fed-Batch Process Utilizing N-1 Perfusion And ambr®15

    While traditional fed-batch bioreactor process development has been well defined using methods such as shake flasks and bench-scale bioreactors, there is a desire to intensify the fed-batch process strategy to increase efficiency and productivity.  Utilization of perfusion during the N-1 stage allows for inoculation of the production bioreactor at a very high cell density. Learn how to combine N-1 perfusion with the ambr®15 bioreactor system to create a powerful tool for rapid development of a highly efficient cell culture process.

  2. Is Your Complex Formulation Process Set Up For Success?

    Any company pursuing a drug delivery system that involves a complex formulation must be prepared for the requirements around this type of drug development to achieve successful scale-up.

  3. 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.

  4. An End-To-End, Semi-Continuous Process For mAb Production

    See how the different unit operations in a laboratory-scale monoclonal antibody (mAb) process can be connected and integrated into a semi-continuous process.

  5. A Next-Level Innovation In Single-Use Bioreactors—Unmatched Design, Scalability, And Performance

    Building upon the success of the robust HyPerforma bioreactors first launched in 2006 and updated in 2013, we introduce our newest innovation: the Thermo ScientificTM HyPerformaTM DynaDrive Single-Use Bioreactor. This single-use bioreactor was designed to accommodate modern cell culture processes and has features that will help you save time and costs and enable your bioprocessing and scale-up success.

  6. 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.

  7. 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.

  8. 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.

  9. Optimizing Drug Safety And Efficacy Of Complex Next-Generation Biologics

    Learn what challenges exist when developing biologic drugs to be efficacious but safe and how novel analytical techniques, like surface plasmon resonance, can help circumvent these issues and optimize development.

  10. Purification Of Antibodies With Nuvia aPrime 4A Hydrophobic Anion Exchange Resin

    A new hydrophobic anion exchange mixed-mode resin, Nuvia aPrime 4A , has been developed to overcome existing challenges in antibody purification. This application note describes two case studies on the purification of an acidic and basic antibody using this mixed-mode chromatography resin through bind-elute and flow-through modes of purification.