With this year’s Disposable Solutions meeting in Munich rapidly approaching I will focus this blog on some of the issues which I hope will be covered in presentations and discussions.
Looking back we find that over the last year there have been a number of significant developments in the single use field, both from a processing and system design perspective, with the development of single use fermenters from GE and Thermo Fisher, and from a regulatory perspective, as we have seen the publication of the long awaited PDA technical report. We have also seen large facilities such as the Amgen facility in Singapore coming on-line based heavily around the use and philosophy of single use technologies. Underneath this, there have been a number of on-going developments in the area of standardisation, where there was much debate in last year’s Disposable Solutions meeting, also in Munich. Whilst it is clear that there is a lot of activity going on in this field, it is less clear when we will see agreement and implementation of these standards.
From a technical perspective the industry continues to innovate; I think probably the most interesting from my point of view in recent months has been the development of single use fermentation systems both at the small development scale but also now up to the 300L scale. The production of products from microbial systems has seen a resurgence in interest as drug development companies seek to broaden product portfolios beyond antibodies, however the cost and availability of multi-product facilities has stymied these developments. I think single use devices have the potential to really help to reinvigorate the microbial products field for the production of therapeutic products. I notice within the meeting we also have presentations on the use of single use systems in fill/finish procedure and in regenerative medicine; from a personal perspective I think the latter is a fascinating area of development which has only been made possible by the availability of single use technologies.
From a regulatory aspect, the long awaited PDA Technical Report 66: Application of Single Use Systems in Pharmaceutical Manufacturingwas published in October 2014 and is clearly based on the use of single use systems in development and manufacturing environments. I will be interested to hear the background to these guidelines and also how far companies are progressing with regards to implementation in development as well as manufacturing production facilities and the challenges they have faced in doing so.
The issue of standardisation is the topic of a number of presentations and has been the focus of several recent articles, both in terms of system designs but also, and arguably more importantly, with regards to build, safety and testing standards. This area is clearly very complex with multiple groups working to develop standards around differing areas of single use systems manufacturing and supply chain. Clearly the challenge will be one of harmonisation and adoption by manufacturers and recognition.
Overall I am looking forward to a really interesting meeting with fascinating presentations and workshops which will hopefully inform and enlighten the attendees on the challenges and opportunities that lie ahead with single use systems.