Optimizing the upstream portion of the gene therapy production workflow sets the stage for successful manufacturing by maximizing viral vector titers. Without the benefit of a proven template, however, process development teams must evaluate all aspects of viral vector production including:
To minimize variability and risk across these process inputs, gene therapy manufacturers can collaborate with an experienced technology partner with expertise in all aspects of viral vector production as well as related products and services.
Frozen cells from a working or master cell bank are thawed and expanded to increase their numbers in preparation for subsequent processing steps.
Cell culture media are optimized with the appropriate nutrients, supplements, and pH for cell growth and virus production.
Cells are grown in a bioreactor or other controlled environment under specific conditions to maximize virus production.
In AAV production, host cells are lysed by chemical or mechanical means so that the viruses can be released into the media.
Unwanted whole cell and plasmid DNA is digested using a nuclease enzyme.
We offer a broad portfolio of raw materials and chemical components suitable for cell culture media formulations and upstream applications used in biopharmaceutical production.
The Sf-RVN® Platform is a two-part system comprising a proven Sf-9 cell line devoid of Sf-rhabdovirus (the Sf-RVN® cell line) and a chemically defined medium engineered for the cell line, the EX-CELL® CD Insect Cell Medium.
Our products and services for AAV, Lentivirus and other viral vectors provide solutions to your most challenging pain points around process development, speed, manufacturing and regulatory guidelines.
Interview transcript with GTRI and their findings of using the Sf-RVN® Platform.
Benzonase® nuclease efficiently digests DNA and RNA into fragments smaller than 5 base pairs.
For improving the safety profile of your gene therapy and vaccines.
From scale-up to overcoming regulatory hurdles and zipping through production.
Successfully scale your gene therapy production by implementing a platform process from the start.
The production of AAV viral vectors for gene therapy comes with unique upstream challenges. Learn how our HEK platform can solve these challenges.
Efficient virus purification processes can improve yield, decrease time to patient, and lower manufacturing costs
Formulating a commercially viable gene therapy demands a high level of application and regulatory expertise
Critical biosafety testing and characterization of viral vector products can help mitigate safety concerns and increase product understanding
CDMO partnerships play a critical role in advancing clinical pipelines and achieving successful commercialization
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