Dr. Cattaneo is featured in GEN March 2020 edition on Viral Vector Manufacturing
About 30% of the cost of a gene therapy drug is due to the cost of goods (COGS). By changing the process of manufacturing from adherent cell culture systems such as cell factories to perfusion systems such as the VHU® it is possible to reduce the COGS by 90% thus significantly reducing the cost of this new therapeutic modality.
The VHU® can be operated in continuous harvesting mode to reduce the cost of pDNA, which is the most significant cost of a transient transfection based viral vector production. Alternatively, the VHU® can be used in process intensification to increase the cell density by 2 orders of magnitude, from 1 million cells/mL to 100 million cells/mL thus increasing yield of protein-based therapeutics such as VLP vaccines by 2 orders of magnitude and decreasing the cost of goods of VLP vaccines by about 90%.
The VHU®1 is our smallest perfusion filtration system, ideal for DOE studies for viral vector or VLP manufacturing optimization. We are currently offering the VHU®1 at competitive prices.
Viral Like Particles (VLP) are being used as flu vaccines because of their extremely low risk since they do not contain any infectious viral RNA. This could make a difference in the ability to produce a safe coronavirus vaccine. In:
Arunachalam Ramaiah1,2,* and Vaithilingaraja Arumugaswami3,*Insights into Cross-species Evolution of Novel Human Coronavirus 2019-nCoV and Defining Immune Determinants for Vaccine Development., Jan.29.2020
Q: Can we use the VHU® harvest viral vectors as well as viral like particles (VLPs) of size greater than 100nm?
A: Yes, the VHU® is ideal for continuously harvest viral vectors and viral like particles when used in perfusion mode.
Q: What is the main advantage of using perfusion over batch processes?
A: The main advantages are: (1) a reduction of media volumes because the perfusion bioreactor is significantly smaller (100L) compared to the batch bioreactor (1000L). (2) By operating the smaller 100L bioreactor in perfusion mode you generate between 300L to 600L of harvest compared to 1000L of harvest in the batch bioreactor, which corresponds to a 50% decrease in media consumption for the same viral vector yield.
Q: What about plasmid DNA consumption?
A: Since plasmid DNA is added to a smaller bioreactor in perfusion mode there is a significant decrease in the amount of plasmid DNA needed for transfection compared to a batch process. The reduction in plasmid DNA can be as high as 90% which is a significant' cost reduction since plasmid DNA corresponds to the greatest cost of materials per batch.
In-line Self-calibrated pH Monitoring System with Hyperspectral Imaging and Deep Learning
Participants: University of Maryland, Artemis Biosystems and Genentech
This project aims at developing an automated system for in-line, non-invasive, self-calibrated pH and/or related DO and glucose measurement in pharmaceutical processing. It directly responds to the NIIMBL call topic 6.1 and the need from leading members of pharmaceutical industries. The system utilizes the hyperspectral imaging technique to capture spectrum information (900-2500nm) of samples and reference buffer media simultaneously. Through deep learning models, the system is expected to automatically extract spectrum information and make accurate in-line measurements. This hyperspectral imaging technique has advantages over conventional Fourier transform infrared spectroscopy in noise-resistance, low variation, high accuracy, and self-calibration functions.
The system at MRL 4 will go through a two-step development process with nine months each. First, the system including a universal adaptor (single-use or large batch) will be established. The deep learning model will be trained offline and pre-loaded to the system. Second, the prototype will be in-house tested in the UMD IBBR bioprocess facility. The potential impacts include labor savings, eliminating risk of microbial contamination, enhanced product quality and yield, in-line real-time pH monitoring and self-calibration.
January 1, 2019
The National Institute for Innovative Manufacturing of Biopharmaceuticals (NIIMBL) has awarded the consortium comprised of Artemis Biosystems, Johns Hopkins University, MassBiologics, Rensselaer Polytechnic Institute, Repligen and Unum Therapeutics a grant entitled "Improved Lentiviral Vector Biomanufacturing for Cell and Gene Therapy Applications”. The consortium will use VHU technology supplied by Artemis Biosystems to achieve its goal of developing a perfusion-based method of highly efficient, large scale manufacturing of lentiviral vectors. See: https://niimbl.force.com/s/pc10-012