Lyophilisation and low-bio burden spray drying methods have been around for some time; Nova Laboratories’ Sam de Costa highlights new techniques that are meeting the demands of a changing healthcare landscape.
Downward cost pressure on the world’s largest pharmaceutical companies has undoubtedly created a fragmentation of the drug development industry, evidenced by the continued proliferation of ‘virtual’ companies and the increased use of contract manufacturers to help deliver cutting-edge new drug delivery methods in a more cost-effective way. Nova Laboratories has had aseptic lyophilisation capabilities for almost seven years and offers this service to a wide range of clients, from large pharma to small biotech firms. Increasingly, however, clients have sought alternative processes to lyophilisation to reduce costs and other associated problems.
While lyophilisation is currently the leading method in the manufacture of small molecules and biologicals (peptides and proteins), Nova believes it has limitations that restrict its further development for drug delivery. The company predicts that the next five years will see greater uptake of aseptic spray drying as a more viable alternative to traditional lyophilisation – particularly with the number of blockbusters due to come off patent in therapy areas such as pain management, osteoporosis and mental health.
Aseptic spray drying is a truly enabling technology; its tight control over particle characteristics opens many avenues for drug delivery and presentation. Where new drug development is concerned, Nova is witnessing increased demand in therapy areas such as oncology, especially where clinical trials demand repeat dosing. It believes spray drying will offer companies greater efficiencies, quicker processing and greater flexibility.
The company recently undertook a number of projects in which spray drying, under truly aseptic conditions was not only beneficial, but in some cases also essential to meet certain criteria for quality and delivery.
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