The German contract development and manufacturing organization (CDMO), specializing in aseptic drug substance and virus manufacturing, will add both 50-liter and 200-liter single-use bioreactors.
In addition, it will add a Siemens process control system to bolster the company’s offering from its Cuxhaven, Germany site for good manufacturing process (GMP) compliant manufacturing of live biologicals.
Stefan Beyer, managing director at Vibalogics, said in a statement, “This additional processing capability ensures that we have the necessary infrastructure in place to handle larger batch volumes for our customers.”
Vibalogics also invested in an Akta-ready chromatography system for downstream processing and liquid handling for increased volumes in this scale of operation.
Beyer stated that the company is growing quickly and is now in a position to serve a broader customer base for late-stage clinical trials and will continue to invest. He added that the company currently has orders in place for the system up to the second half of 2020.
This expansion builds on the company’s previous addition of an automatic filling line in 2016, which extended its aseptic fill and finish capability by 300% to support early -phase biologic supply for Phase I and II clinical trials.
Previously, Sirion and Vibalogics collaborated for adeno-associated virus (AAV) services for the development of gene therapies for preclinical batches.
Oncolytic viruses can be used to cause cell death in tumors. They are also able to vectorize and deliver recombinant functions into the microenvironment of the tumors to reshape the environment. Growth in the market for oncolytic viruses has seen recent collaborations, such as between Transgene and AstraZenca.
Daniel Eisenman recently delivered a talk at ACRP 2019, where he discussed the growth of cell and gene therapies, and stated that the first gene therapy product approved by the US Food and Drug Administration (FDA) was an oncolytic virus designed to kill cancer cells in melanoma.
