Anhydro Designs Aseptic Spray Dryer for Tuberculosis Vaccines
Anhydro has just completed a high-profile project covering a ‘proof of concept’ scale ‘sterilisation in place’ aseptic spray dryer for aseptic processing of TB vaccines – the first in the world. This dryer was provided to Aeras Global TB Vaccine Foundation to support the development of a critically needed vaccine for aerosol delivery.
The Aeras Global TB Vaccine Foundation is a product development partnership (PDP) dedicated to the development of effective tuberculosis vaccine regimens that will prevent TB infection in all age groups and will be affordable, available and adopted worldwide. Someone in the world is infected with tuberculosis every second. Two billion people worldwide are infected with TB – about one out of every three people on the planet. Of these, nearly 1.8 million die a year from TB. Multidrug-resistant (MDR) and extensively drug resistant (XDR) tuberculosis is becoming a threatening issue in developed countries as well.
The only existing vaccine against TB is the Bacille Calmette-Guérin (BCG) vaccine, which is over 80 years old. Unfortunately, the current BCG vaccine is only partially effective.
Aeras’ mission is to advance the world’s leading TB vaccine candidates, and to maintain a robust TB vaccine pipeline so that subsequent generations of better vaccines that prevent reactivation of latent infection will be brought forward.
The spray-drying technology could make vaccines against any disease, not just TB. The powder is easy, fast and cheap to make, and it’s stable at room temperature, unlike most traditional vaccines, which have to be kept cold. Anhydro designed the Aeras dryer to meet the demands of the biotechnology pharmaceutical industry and agency guidance to a produce clinical injectable drug product. The processor was designed for aseptic processing including a heat treatment depyrogenation function. Plus all the gas flows entering the processor are sterile filtered.
Anhydro enabled this processor to accept BL-2 level hazard infectious substances. The processor is compatible with external sanitisation and is equipped for two types of internal sanitisation. The internal sanitisation prepares the processor for disassembly after processing.
The vaccine/drug products processed in this ‘state-of-the-art’ processor have ultra low bio-burdened and are sterile. Anhydro delivered, commissioned and validated the plant in strict compliance with the project milestones agreed at the time of the order.