A Swiss firm is offering the first process risk management and safety certification for pharma companies working with nanoparticles and technologies.
At least two pharma companies are already in talks with The Innovation Society, which has developed the Cenarios system (Certifiable Nanospecific Risk management and Monitoring System) that collates risk related information from scientific, regulatory, technological and market sources to generate a database of material to be applied to specific products and processes using nanotechnology.
There is currently no nanospecific regulatory framework in existence, so this new certification system aims to provide a level of safety and compliance in the rapidly growing but still somewhat unknown field of nanotechnology.
"Our aim was to establish a safety label which gives more security and safety to industry, and a reliable standard in the supply chain," Dr Christoph Meili of The Innovation Society told In-PharmaTechnologist.com.
According to the company, the Cenarios system provides a structured way for firms to identify, analyse and assess potential risks and opportunities in products and processes. By constantly updating the database in line with new research or regulatory developments, companies are made aware of changes at an early stage and able to react accordingly.
"It is very heavy duty for a company to monitor all the risk relevant information generated by the media, science etc," said Meili.
"The Cenarios system essentially does this for them."
Within the pharmaceutical industry, nano-sized particles and technologies are increasingly coming to the fore, particularly in novel drug delivery systems. According to the company, one of the most promising areas of application for the Cenarios certification would be for nano-based drug delivery technologies such as fullerenes (so-called 'bucky-balls') and carbon nanotubes.
"We believe drug delivery systems are one of the blockbusters for nanotechnology in the pharma industry," said Meili.
"But companies have to be careful to ensure safety as far as production and application are concerned."
The database of risk-relevant information for fullerenes and carbon nanotubes is growing rapidly as more research is carried out, and the company believes it is important that pharmas are aware of the growing body of information and its relevance to their production processes and standards.
The Cenarios system is applied in three parts: risk and hazard assessment and evaluation, a risk monitoring system, and issues management and communication. Communication is of key importance, particularly in terms of issue management, explained Meili.
"Companies have to ensure they are in a reliable issue management chain and must be able to react," he said.
This was never more evident than in April last year, when a bathroom cleaner product called Magic Nano went on sale in Germany. Based on nanoparticles, the product was hastily removed from the shelves three days later after hundreds of people reported severe respiratory problems and pulmonary oedemas.
After several months the cause was eventually identified as a chemical toxicity problem rather than the nanotechnology that critics were keen to blame (the product was actually found to contain no nano-sized particles to begin with.) However, it was enough to ring alarm bells in the nanotechnology community and prompted the development of the Cenarios programme.
"Magic Nano was a catastrophe for the industry," said Meili.
"But the community began to realise that safety is a key issue in nanotechnology."
Since introducing the certification programme, there has been huge interest from companies hoping to employ the risk management system. According to Meili, at least two pharmaceutical firms are in early stage talks with a view to implementing the system.
Costs vary depending on how many products and sites are included in the assessment and analysis, but consists of a one-off payment for the initial set-up of the system and then further payments over the years for re-certification to cover continuous monitoring and updating of the system to ensure companies are kept up to date on the latest developments.
The system is due to be implemented for the first time at Swiss technology firm Buhler Partec in June this year, with certificates issued by TÜV-SÜD, the international certification organisation.
The Innovation Society is also involved in nanotechnology safety and risk assessment for the authorities, and is currently advising the Swiss government on the Swiss Nanotechnology Action Plan.
More details about the Cenarios system can be found here .