INSIGHTS ON UPSTREAM MANUFACTURING

• An Integrated Single-Use Platform for Manufacturing Plasmid DNA (pDNA)

  Plasmid DNA (pDNA) plays a critical role in the delivery of gene therapies into targeted cells. The development and delivery of large quantity, high-quality pDNA vectors are in high demand. Cytovance has developed and integrated Single-use Platform for manufacturing Plasmid DNA (pDNA) using the HyperGRO™ high cell density process that is licensed from Nature Technologies, an industry leader in the field.

• Alternatives To In Vivo Assays For Biosafety Testing Of Biologics

  The use of animal models for the detection of adventitious agents has been a feature of biologic testing packages for many decades. However, as alternative methods such as PCR and NGS have emerged these in vivo tests have stubbornly remained a central part of testing. Here we examine the current in vivo methods and explore alternatives which can be employed today.

• End-User Evaluation Of 30 L And 300 L HyPerforma Single-Use Fermentors And Scale-Down Model

  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.

• Use Of Nunc Cell Factory Equipment To Accelerate Workflows And Increase Product Consistency

  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.

• Introduction To Mass Transfer In Single-Use Bioreactors

  Mass transfer in single-use bioreactors is complex and often misunderstood, yet critical to the growth of cells in culture, This paper aims to elucidate the standard mass transfer model.

• Parallel Fed-batch CHO Culture On SciVario® Twin

  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.

• Dissolved Oxygen Control PID Tuning For Cell Culture Applications

  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.

• Dissolved Oxygen Control PID Tuning For Cell Culture Via Chemically Produced Demand Simulation

  Eppendorf bioprocess controllers, such as BioFlo 320 Bioreactor Control System, use proportional– integral–derivative (PID) control mechanism for variety of processes. This includes DO control. The PID control loop mechanism for DO control is essential for optimal bioreactor cell culture. Although the D value is not user adjustable in Eppendorf controllers, the P & I values can be changed.