Over the last few weeks I have been fortunate enough to attend a range of meetings with the subject matter ranging from flexible facilities, through to gene therapy and the production of bacteriophage. Through these I start seeing common themes. The first of which is the challenge of producing small volume products down to patient specific medicines and the second that of affordability of new products and patient access to new medicines.
This is becoming an increasing area of conversation in manufacturing circles, as we move initially towards smaller volume products, including a significant number of new orphan drugs and potentially towards patient specific products and the concept of “flexible facilities”. The ever increasing developments around single use systems are also opening up new possibilities in terms of scales and strategies which are still very much evolving. We are seeing the opportunity to develop innovative production systems, including closed manufacturing systems and the potential for multiple production streams within facilities.
Alongside this we are also seeing the development of much more powerful process development tools allowing for genuine QbD (Quality by Design) approaches to be used for key process operations. However, manufacturing groups are not the only ones involved in the production process, clearly also included are development, quality, regulatory groups as well as supply chain management and operational staff at all levels. As I have highlighted previously an issue with the development of single use systems where there was a clear disconnect between the ambitions of manufacturing groups, quality and regulatory groups overseeing the use of these systems. As we move forward towards these new manufacturing strategies we need to look at how we can achieve the required levels of product safety, compliance and security of supply for these products at affordable costs.
Historically, products have been targeted at large patient markets with production often in dedicated manufacturing facilities, with internal regulatory groups and structures being established around this manufacturing approach. The cost of compliance in such facilities is justified when compared to the cost of batch failures and is seen as an acceptable overhead within the overall production costs. As we come down in scale and market size we run the risk that the cost of compliance will start to represent a much larger portion of the overall manufacturing costs, especially when you include activities such as process development, characterisation and validation to a point where they will become prohibitively high for development and production activities.
Going forward, I think we need to see how we can evolve approaches both internally and externally where development and manufacturing are performed in much greater co-ordination with quality and regulatory groups; such as how we can empower modern process development and analytical tools to define operational spaces for processes more readily and reduce validation costs. Can we also develop “platform processes and production” for more products where we can further disconnect not only process development but also process and analytical validation activities from specific products and potentially manufacturing steps?
The next generation of bio-therapeutic products will raise challenges for manufacturers and regulators alike, but if we recognise the tremendous opportunities and patient benefits these products can bring and work together to develop a solution that meets manufacturers and regulatory needs alike we will then have the opportunity to bring them to market to meet patients’ needs.