Bioprocessing Application Notes & Case Studies

  1. 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.

  2. 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.

  3. 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.

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

    Biomolecules are becoming more complex. Bio-Rad’s newest hydrophobic AEX chromatography resin, Nuvia aPrime 4A, is designed with distinctly balanced modes for better interactions to purify your toughest targets. Now you can triumph with even the most challenging biomolecules. Learn more about Nuvia aPrime today and experience a wider design space delivering high purity and yield.

  5. Truly “Focused on Faster” For Aseptic Filling

    A small, research-focused biotechnology company received incredibly positive results in the clinic for their current program and was instructed by leadership to push ahead quickly with an aseptic fill for another trial. They urgently needed help to get their finished drug product clinical supplies to their distributor by December to make it in the clinic by January 2020.

  6. Implementation Of Single-Use In Drug Substance Filling Before Transportation

    The development of a new product or service is better done as a collaboration between the developer and the potential end user(s). Systems developed in isolation often end up answering questions no one has ever asked, or fail to develop a full solution. With that in mind, this article discusses the product development cycle of a system for bulk filtration of Active Pharmaceutical Ingredients (APIs), how this development progressed from generation one to two and the lessons learned along the way.

  7. The Combination Of UCOE® Expression Technology With The CHOZN® Platform Reduces Resources And Cell Line Development Timelines

    In biopharmaceutical manufacturing, the of an expression system that stably produces high levels of desired recombinant protein can be a time-consuming and resource-intensive process. This process takes many months, requiring large amounts of personnel time, supplies and equipment. Our goal in this study was to modify a well-defined cell line development system to generate high performing recombinants in a time- and resource-efficient manner.

  8. Purposeful Design And Development Of A Next-Generation Single-Use Bioprocess Film

    Fortem film development is an important investment by GE Healthcare, as it helps meet the industry need for a fully characterized platform film across all bioprocessing applications with supply chain transparency as a focal point. 

  9. Meeting Patient Needs Through Expedited Delivery Of Phase I Materials

    To quickly deliver their product to patients in need, Reneo Pharma teamed up with Thermo Fisher Scientific to take advantage of its Quick to Clinic for Oral Solid Dose program.

  10. Transient Lentiviral Vector Production In HEK 293T Cells Using The BioFlo 320 Control Station With A BioBLU 5p Single-Use Packed-Bed Vessel

    Lentiviral vectors (LVs), which are especially applicable to gene therapy, are promising vector types for the clinical trials of such treatments. Current bottlenecks in the production of LVs are caused mainly by the disadvantages of classical two-dimensional culture forms. Switching to bioreactors can eliminate those disadvantages and offer the benefits of process automation, tight regulation of production conditions, and reduced labor input. This application note describes the first successful experimental setup to cultivate LVs in HEK 293T cells adherently grown on Fibra-Cel® disks in a BioBLU 5p Single-Use Vessel.