Off the shelf bio-processing
The drivers for drug developers seeking to take products into clinical trails are nearly always cited as being cost and time, with timelines often being the over-riding driver. It is therefore not surprising that vast amounts of effort have been invested by pharmaceutical companies and CMO’s to develop platform manufacturing processes for key product areas, especially monoclonal antibodies. These have offered companies the potential for highly accelerated development programmes and significant reductions in development timelines. In recent times we have also seen widespread adoption of single use systems throughout manufacturing processes for early stage clinical products; seeking to reduce costs and the timelines for the production of materials for clinical trials.
The major equipment suppliers have for a number of years been developing products targeted to the monoclonal antibody market. Whilst the initial response by some suppliers tosuppliers to the single use market was relatively slow, in recent years we have seen very significant levels of investment and acquisition such that several of suppliers are now able to supply complete packages of process equipment and associated consumables. The focus for many seems to be very much on the development of direct like –for-like replacement of stainless steel for single use systems ( rather then developing new approaches to manufacturing) and more recently we have seen these services extended to the point of supplying supporting consultancy services and even manufacturing and analytical services.
On one level these approaches seem to provide simple solutions to what used to be highly challenging technical problems, with “one stop shops” providing not only the equipment but also the process to make your product, suggesting the need for expensive process development work programmes with large development teams may be a thing of the past. For some product areas and markets this may well be a persuasive argument and it would be disingenuous not to recognise that these approaches genuinely seek to address a real issue within the industry of reducing timelines and cost for getting new products from the research bench to the clinic.
However, I think it is wise to add some notes of caution to these approaches in the development and manufacturing of new clinical products and the function that those groups are really seeking to achieve.
To me process development groups are very much service providers to drug development groups, responding and providing solutions to those groups to enable new ideas to be taken from the bench to the clinic. To achieve this, there needs to be development teams with the skills and abilities to provide the technical solutions to the manufacturing challenges new products and product types bring with them and for suppliers to help provide the tools to achieve those manufacturing solutions.
With the development of platform processes and even more so with “off the shelf” processing some organisations are running the risk of developing a one-size-fits-all approach where new product will need to fit into the existing manufacturing process. We should not be tempted into trying to impose restrictions on the products and ideas being conceived within development groups, stifling innovation and potentially depriving patients of beneficial and innovative products. As I have mentioned previously, single use systems have the potential of offering new and highly innovative solutions to the bio-manufacturing industry , but I feel there is a risk of missing great opportunities if developments are simply restricted to those solutions which offer short term commercial attractions to the industry.