Bioprocessing Application Notes & Case Studies

1. How To Avoid Bag Breakages With Product Loss 4/1/2020

   A global Contract Manufacturing Organization (CMO) produces different drug substances (BDS) of highly valuables mABs in batch sizes from 10l to 700l for clinical phases up to commercialized products. They were facing a challenge with single use bags with a high loss rate of 0,5% to 5% due to their sensitivity at sub-zero temperatures. Read how they set up a cold chain process and implemented robust technologies around the brittle single use bag and to consequentially reduce product loss.

2. Validated Shipping Of Filled Labtainer Pro BioProcess Containers (BPCs) 4/1/2020

   Wet shipping tests are performed to ensure that Thermo Scientific™ Labtainer™ Pro BioProcess Containers (BPCs) maintain  integrity, keeping contents contained and protected. During shipping, wave action within a fluid-filled BPC exerts stress on the film, which can lead to cyclic fatigue of the materials. A variety of shipping tests were conducted on the Labtainer Pro BPC product line, including vibration testing, compression testing, and drop testing. Following the completion of this testing, all chambers were integrity-tested for leaks.

3. End-User Evaluation Of 30 L And 300 L HyPerforma Single-Use Fermentors And Scale-Down Model 3/27/2020

   In moving processes from bench to pilot and ultimately production fermentors, it is critical to have a reliable scaledown model. Scale-down models can vary depending on the media, strain, and process conditions. In this case, a customer wanted a scale-down model of the Thermo Scientific™ HyPerforma™ Single-Use Fermentor (S.U.F.) in order to establish what fermentation processes could be scaled into the S.U.F., in particular for the production of plasmid DNA.

4. Use Of Nunc Cell Factory Equipment To Accelerate Workflows And Increase Product Consistency 3/27/2020

   Scaling up adherent cell culture can be a difficult process for many vaccine, cell therapy, gene therapy, and viral vector manufacturers. Some cells can alter their properties if they are not cultured in specific conditions. The simplest way to mitigate all these risks is by using a multi-layered vessel, such as the Thermo Scientific™ Nunc™ Cell Factory™ system, in a closed system with automation equipment.

5. Parallel Fed-batch CHO Culture On SciVario® Twin 3/23/2020

   We performed fed-batch cultures using BioBLU® 1c and 3c Single-Use Vessels controlled in parallel by the new SciVario® twin bioreactor control system. This method highlights the SciVario twin’s capabilities to run complex processes simultaneously using various sized vessels.

6. Dissolved Oxygen Control PID Tuning For Cell Culture Applications 3/20/2020

   This paper introduces a method to optimize PI values using a proportional–integral–derivative (PID) control mechanism for a variety of processes, including dissolved oxygen (DO) control.

7. Scale-Up Of Fed-Batch Process Utilizing Dynamis Medium And EfficientFeed C+ Supplement In HyPerforma S.U.B.s 3/16/2020

   One key factor for ensuring comparable growth and productivity during cell culture scale-up is pH control. pH impacts many factors in this process, including specific productivity, cell growth, and cell metabolism. Here we demonstrate the scalability of a fedbatch process of CHO cells in Gibco™ Dynamis™ Medium with Gibco™ EfficientFeed™ C+ Supplement, utilizing a pH shift strategy.

8. Hyper-Productivity In Your mAb Purification Step 3/15/2020

   Learn how a tenfold increase in productivity of 200 g/L/h compared to the industry norm was possible through an intensified Protein A capture process.

9. Development Of A GMP Strategy For ADC Synthesis 3/10/2020

   As antibody-drug conjugates (ADCs) gain more attention and clinical/commercial success as a form of targeted cancer therapy, the demand for technologies which widen the therapeutic windows for ADCs has increased. Multiple site-specific conjugation methods have emerged in response to this need but developing strong and scalable processes remains a consistent challenge. Here we report the establishment and application of a good manufacturing practice (GMP) strategy to produce site-specific ADCs through the implementation of AJICAP technology, a chemical conjugation platform that employs IgG Fc-affinity peptides.

10. TPE Tubing Weld Testing 3/3/2020

    This tech bulletin demonstrates the aseptic weldability and sealability of thermoplastic elastomer (TPE) tubing for use in numerous applications requiring aseptic liquid transfer.