Vital expertise in oncolytic virus production
Oncolytic viruses (OV) have proven to be very effective weapons in the fight against cancer. OVs infect and replicate in tumour cells. They not only primarily lyse infected cancer cells, but usually also exhibit immune-modulating and adjuvant properties, as they present tumour-specific antigens to the immune system or express immune-modulating cytokines. OVs, therefore, offer a number of advantages as compared to other forms of cancer therapy: they act in a targeted manner, transform invisible “cold” tumours into “hot” tumours that are attackable by the immune system, and activate the immune memory to suppress metastases and relapses. A combination with immune-check-point inhibitors further enhances the effect immensely.
With the approval of Amgen’s Talimogene laherparepvec (Imlygic) in 2015, more than 100 companies worldwide have turned towards the development of OVs. Pharmaceutical giants such as AbbVie,
Bristol Meyers Squibb, Johnson & Johnson, Boehringer Ingelheim and others, have entered into licensing and development partnerships with OV companies or have acquired such companies altogether. Currently, well over 150 clinical trials are ongoing, with approximately 80% of all OVs in early development.
The challenge of manufacturing
OV candidates are derived from a wide variety of virus types such as herpes, adenoviruses, vaccinia, parvo, arena and others. The production systems are as diverse as the viruses themselves: Adherent or suspension growing Vero, HEK293, HeLa S3 and A549 cells as well as chicken fibroblasts are used. The aim is to maintain the infectivity of the viruses after upstream and downstream processing as highly concentrated and active virus solutions are required for clinical trials.
Vibalogics is a fast growing global service provider in the field of live virus production. Processes are developed using suspension bioreactors or fixed bed manufacturing platforms, as well as multi-unit CellStacks and Roller Bottles. Egg-based manufacturing also has a role for certain viruses. After downstream development and process upscaling, aseptic process validation in BSL-2 classified clean rooms is performed if necessary. Analytical methods are developed concurrently to characterize and quantify the virus prior to clinical trial material supply. Bulk material and finished Drug Products of up to 30,000 vials per batch are supplied. Lyophilization is also an option and up to 3,000 vials per batch are possible. Remarkably, now in 2020, clinical test material for SARS-CoV-2 is being produced and supplied: A testament to the speed at which our industry is developing.
The capacities at the site in Cuxhaven, Germany, will be further expanded with a 500L Single-Use line and a facility for late stage clinical development and commercial production is being planned in the United States.
This Advertorial was published in the European Biotechnology News Magazine Summer Edition 2020.