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.
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.
4SC AG, a clinical-stage biopharmaceutical company partnered with Patheon, by Thermo Fisher Scientific, whose experienced team helped them overcome active pharmaceutical ingredient (API) manufacturing hurdles, leading to a path toward commercial success.
Accurate flow is important for your chromatography step to provide reproducible results at different scales. For ÄKTA pilot 600 chromatography system, flow and gradient formation is controlled by the UNICORN™ system control software. In this work, flow accuracy was investigated at a combination of different backpressures, flow rates, temperatures, and liquid viscosities.
The ÄKTA pilot 600 chromatography system is designed to facilitate sanitization, with the high standards imposed by regulatory authorities for purity of the clinical products in mind. In this study, the predefined sanitization method developed for ÄKTA pilot 600 was assessed.
Global regulatory standards for clinical trials are, simply put, complex. In this case study, learn how one company worked with its partner to overcome the challenge of a protocol based in the US, an investigational medical product (IMP) approved in the EU, and varying QP (qualified person) rules from country to country, to conduct their clinical trial in Isreal.
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