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.
To meet the oxygen demand of cells a stable pO2 control is an essential part of every cultivation. The objective of this application note is to demonstrate the performance of a new generation of mass flow controllers in the BIOSTAT® B-DCU bioreactor system. Several comparative cell cultivations were performed.
Ensuring that the cells do not have too much or too little, enables them to grow fast and maximize the product secretion. Within this application is an example method on how to establish glucose feed control is documented and as well as highlighting the key benefits of applying this method to other processes.
The motivation for utilizing single use (SU) bioreactors is the reduced turn-around time and labor required for cleaning and autoclaving traditional glass vessels as well as the associated costs for maintenance and repair. Sartorius’ 2L UniVessel® SU has an option for an external water jacket system controlled by Sartorius’ BIOSTAT® controllers. In this study, we determined the feasibility of the UniVessel® SU and BIOSTAT® B-DCU II combination by performing detailed comparability studies of cell growth, viability, monoclonal antibody (mAb) productivity and product quality attributes (aggregation, charge variation and glycosylation) using three recombinant CHO cell lines.
Challenges of T cell immunotherapies include the costly manufacturing process relying on lengthy and complex open workflows with high manual labor requirements that influence product variability. This application note describes the details of a robust CAR T cell manufacturing workflow that can be adapted for cGMP compliance in commercial production of CAR T cells.
There is an increased risk of viral contamination in settings where ATMPs are prepared, making it critical to understand the contamination risks and the solutions available to control them.
Watch this video from Pall Biotech to learn about the advantages of single-pass tangential flow filtration versus traditional tangential flow filtration.
This video will give you an introduction on the Xuri™ W25 cell expansion system. You’ll get an overview of the system control capabilities which make it suitable for use in a regulated environment, and its flexibility to handle multiple indications with various cell types.
This video provides and overview on the Sefia™ cell processing system, The overview will show the intuitive interface with augmented process control and integrated traceability, easy to implement at your cell therapy activities.
This video provides an introduction to the Sepax™ C-Pro, cell processing system, showing how to start a procedure and preparing and installing the corresponding kit.
Watch this video to learn the important decisions that each biopharma executive must make to break down roadblocks during the critical first step of cell line development and bring their molecule to clinic successfully.
A next-generation bioprocess control station, designed as a universal platform capable of meeting the ever changing needs of all segments of the biotech and pharmaceutical sciences.
Monoclonal antibodies (mAbs) are highly complex biomolecules easily affected by changes in the biopharmaceutical manufacturing process. Something as simple as a temperature fluctuation can produce a change in higher order structure (HOS) that renders the mAb less active or inactive. Whether your mAb is an original product or a biosimilar, our comparability studies are designed to ensure robust and reproducible mAb production.
Our Product Characterization services offering combines mAb physicochemical and structural information with the activity profile captured from binding, affinity, and potency bioassays to better understand the function of your drug—its critical quality attributes. All testing is performed in a GMP qualified laboratory and is compliant with ICH guidelines, FDA, and EMA regulations.
Many different impurities are present in or generated during the mAb manufacturing process. We work to make sure your biotherapy’s development program isn’t derailed by process or product contaminates that can arise from raw input materials, occur as residual processing agents, or formed as reaction by-products.