For two decades Nova Laboratories has provided clinical trials medication to a global customer base of pharmaceutical and biotechnology companies, academic and charitable institutions and the UK’s NHS. In this time the company has developed extensive expertise in the use of high-integrity, gassed isolator technology, which has been acknowledged by various regulators as ‘Advanced Aseptic Technology’. This expertise in complex and novel aseptic processes, clinical manufacturing of parenterals and devices now provides the company’s main role and has allowed it to develop commercial manufacturing processes for specialist sterile products.
However, it was the news that the US FDA had approved the Raplixa fibrin sealant and spray device that gave the most vivid green light to companies considering and exploring aseptic spray drying (ASD) as a manufacturing option. The FDA verdict marked a milestone for ASD in many ways, and was a significant regulatory milestone. Considering the technology has been available for some years without really achieving mainstream status, it probably takes the FDA decision to make the real difference.
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