While several methods are known for producing live virus preparations for vaccines, the manufacture of infectious virus preparations of consistently good purity and yield has proved difficult.
A process has now been developed for purifying live virus preparations, which comprises harvesting the virus from cell cultures without substantial cell breakage. This minimises contamination by host cell protein and/or DNA, followed by an affinity binding step utilising a solid phase carrying a sulphate or sulphonate-comprising binding group (eg heparin or dextran sulphate) that can bind the virus, and subsequently eluting the virus from the affinity column with a hypertonic salt solution (eg sodium chloride or other pharmaceutically acceptable salt over about 0.4M).
The virus can then be formulated with a pharmaceutically acceptable excipient, and optionally sterilised and frozen or freeze-dried.
This methodology is especially applicable to infectious preparations of human herpesviruses such as herpes simplex virus (HSV), eg HSV type 2, which can tend to remain strongly cell-associated when grown in culture.
However, the process is generally applicable to other viruses and, importantly, is readily applicable in a cGMP setting.
Xenova Biomanufacturing is a contract-manufacturing organisation providing biologics development and manufacturing to the biopharmaceutical industry.
The company delivers vaccines, therapeutic proteins and viral vectors from research through process development into manufacture for Phase I, II and III clinical trials. Its team of scientists offer process and analytical development and the manufacture of a broad range of biological medicines from therapeutic proteins to live viral products.
Xenova Biomanufacturing’s GMP compliant facility is MHRA authorised and meets FDA and EU Clinical Trials Directive requirements.
Xenova Biomanufacturing is based in Cambridge, UK. www.xenovabio.com
