Drug development and drug delivery innovations are creating major headaches for contract manufacturers. John Seaton, financial and commercial director reveals how, when the ‘perfect storm’ of aseptic processing challenges came along, Nova Laboratories provided a system to meet them
Nova Laboratories has been engaged in contract manufacturing for more than 12 years – from clinical trial materials to commercial supplies – so solving problems with unique characteristics is a normal part of its remit. In the past, it has been approached to handle a wide range of novel applications in partnership with organisations large and small, using its pioneering gassed isolator technology (acknowledged by the MHRA and FDA as Advanced Aseptic Technology). But never before had it been asked to tackle them all in one go.
The huge challenges faced by those trying to solve the world’s vaccination problems continue to make international news headlines. Vaccine delivery and drug stability are among the many obstacles for developing countries. And as new drug delivery technology is being developed all the time, it brings with it new challenges.
Microsoft founder and philanthropist Bill Gates recently predicted a new vaccinations drive could eradicate polio in two to four years and save four million children’s lives. He hailed a breakthrough in vaccinating the world’s poorest children, as he urged world leaders to commit extra funding, when they attended a global vaccine summit in London. He has also personally pledged £5bn over a decade to eradicate the rotavirus or pneumoccocal vaccines (for diarrhoea and pneumonia respectively).
As Bill Gates spearheads the drive to solve the world’s vaccination problems, Nova Laboratories has been called on to provide innovative solutions to those making it happen. In particular, the laboratory has been using aseptic processing to help a leading drug delivery company to fill an innovative needle-less injection device.
The client presented the perfect storm of challenges. The device needed to be aseptically filled with a very small amount of metallic powder. The weight of the material was 4µg per mg, and the fill volume was 1mg. As a consequence, the temperature, humidity, static, vibration and air pressure all needed to be controlled while carrying out the aseptic process.
Nova specialises in problem-solving and has a flexible, collaborative approach, to ensure that clients’ products are produced to a consistent high quality in compliance with cGMP and industry best practice. The company has been operating isolators for a long time and has come across all these challenges individually, but never together. The team of dedicated engineers had to be innovative, as the project required both serious planning and attention to detail.
The temperature within the isolator had to be maintained within a predefined range. The company also installed a dehumidifying system inside the isolator. To manage the static in an isolator constructed of metal and plastic components and housing moving parts, antistatic bars and other supporting components were fitted.
Vibration can be a major problem but the isolator was secured directly to the concrete floor using bolts. To control air pressure, ‘shrouds’ were designed that could be fitted around the scales, like a tent, to protect it.
The finished system worked perfectly – and as a result received repeat orders from the company.
gassed isolators
Nova Laboratories has built a worldwide reputation in the use of gassed isolator technology for the production of sterile pharmaceutical and biotechnology products and medical devices. Its services include: aseptic production; vial and ampoule filling; spray drying; lyophilisation; syringe filling; emulsion manufacturing; medical device assembly; and live biologics.
With fully validated, dedicated and separate facilities for aseptic spray drying and the fill finish of live biologics, the company also handles proteins, peptides, antibodies and plasmids, which require novel and innovative solutions to aseptic processing problems.
Nova now has the capability to provide instantly injectable, thermo-stable vaccines at tropical temperatures, which has attracted interest from around the world. This pioneering technology could make cold storage problems a thing of the past by removing the need for fridges, freezers and associated health infrastructure like electricity, therefore reducing costs and waste, while offering significant practical advantages.
It is for these reasons that Nova has received a great deal of interest in its two key technology platforms, which have the potential to solve many of the problems that pharmaceutical and biotechnology companies have around stabilising the medicines of tomorrow – including those for vaccination in the developing world.
The company can offer bespoke isolators for pharmaceutical and biotech products
exciting developments
The company has a significant number of exciting development programmes under way with many different customers and for varied applications. For example, VitRIS (vitrified readily injectable suspension) results in a stable, ready-to-inject liquid and removes the need for refrigeration of products. Meanwhile HydRIS (hypodermic rehydration injection system) stabilises the material in a device that makes it very easy to reactivate at the point of administration, using nothing more than a standard syringe and injectable fluid such as sodium chloride. This allows even highly unstable products to be stored for long periods in non-liquid form.
Nova owns what is believed to be the world’s only fully validated cGMP aseptic spray-dryer for the production of clinical material. The facility will accelerate the time to market of VitRIS-based products.
Under sterile conditions the pharmaceutical product is mixed with water-soluble glass formers and dried as a solid, non-crystalline glass using an aseptic spray-dryer. The outcome of this first part of the process is spherical, highly polished microspheres in which the product is immobilised and stabilised. The microspheres could either be suspended in a non-aqueous liquid or used as a rapidly dissolving powder, ready for injection.
Both platforms provide advantages at all stages of the pharmaceutical value chain and were designed for ease and convenience of administration, with true availability at the ‘point of care’. They can improve the way pharmaceutical products are made, stored and delivered (including those based on freeze-drying).
Trials have shown the platforms can be successfully applied to a large number of pharmaceutical preparations, including live biologics (virus/bacteria), vaccines, insulin, monoclonal antibodies, recombinant growth hormones, proteins, enzymes and nucleic acids.
The technology can be applied to both low value/high volume production (such as mass vaccination programmes), and high value/low volume products like bio-defence/therapeutic vaccines, which require rapid deployment in a user friendly format (such as for the emergency services/armed forces).
These technologies can also facilitate brand differentiation, extending the life cycle of marketed products and, in turn, their patent protection.
