What is the current state of acceptance of single-use technologies in the pharmaceutical industry? In your opinion have they become “mainstream”?
Single-use technologies are well into the adoption phase, with most of today’s drug manufacturers implementing them in one or more steps of their small and large molecule production processes. In fact, there are many manufacturers implementing single-use process flows wherever possible, but this is not always feasible depending on the age and scale of both the company and the process.
Hélène Pora, Vice President Technical Communication & Regulatory Strategy, Pall Biotech
While newer facilities and processes are much easier to build with the latest technologies, in the case of existing capital/facility investments and/or processes, there may not be as much flexibility.
As such we have seen a great uptick in the number of manufacturers implementing hybrid systems to replace the most challenging or cost-restrictive traditional steps with single-use steps to optimize capital and efficiency.
Of course, challenges remain in the advancement of single-use technologies, particularly in the downstream. However, in 2017 we saw a great deal of new solutions on the market. At Pall Biotech, we launched the Allegro™ single-use chromatography systems, and made multiple additions to the Cadence™ continuous-enabling downstream portfolio.
Across the industry we also see barriers in varying levels of quality and approach due to many suppliers on the market. This has been one of the greatest drivers for industry standards, including a greater demand for the interchangeability of technologies, analytics, and consumables. Multiple industry associations, including the global regulatory agencies, have been working alongside both vendors and end users to determine the best ways to further nurture single-use development and adoption.
If a pharma company was looking to adopt single-use technologies for the first time – what advice would you give them?
For every manufacturer it is critical to evaluate processes and see where they can take the greatest advantage of the single-use technologies from the earliest point, while also considering the scalability of the process(es) in question. We suggest taking a quality by design (QbD) approach to designing and implementing proven, market driven processes that are supported by the right products and services.
In the case of a new facility or process, we suggest building for flexibility, as we see a much larger focus on modularity and multi-functional facilities for the future. For those already invested in a facility, it is important to consistently evaluate where new efficiencies can be found and implement changes as possible—there is nothing wrong with taking a step-wise approach to replacing traditional technologies.
Because times change, it is critical to work with a supplier that can meet your needs for the life of your process so that you are never left without process support or access to consumables.
Additionally, working with a cutting-edge supplier can help manufacturers stay ahead of the game with access to all the latest advances, and a true understanding of where the greatest efficiencies can be gained in each unique process.
What processes are easiest to transition to disposable technologies and why?
Upstream processes are always easiest to transition to single-use technologies, and many will agree that buffer and media prep/mixing/storing are often the place to start. This is because these steps require a great deal of cleaning and validation steps in traditional methods making disposable formats not only easier to transition to, but also more cost and time-effective by eliminating all the extra resources and steps.
What are some best practices for integrating disposable technologies with stainless steel equipment?
Manufacturers will always be limited by the space they are working in—so it is important to remember that the facility footprint determines a lot of what can and cannot be implemented. There must be enough space to not only accommodate each piece of equipment, but also ensure that each step can be connected properly. Sterility of each set up must also be taken into consideration and accommodated appropriately.
And as with all things, it is critical that operators are trained and updated on all process parameters and expectations. A well-trained staff supported by a world-class supplier helps make integration a lot easier.
What are some of the biggest concerns/problems with using single-use technologies? Are there easy and effective ways to overcome these challenges?
It is hard to ignore the debate over what films are best for single-use technologies. This applies not only to the compositions of the films themselves, but also the formats they are available in.
With many suppliers on the market, the concern is that end-users will be limited in choice without general industry standards to even the playing field. Further work on standards remains to be done, but there is a general feeling across the industry that we are getting there sooner rather than later.
Currently, disposable technologies are primarily used for biopharmaceutical production. Do you see their use expanding into other dosage forms? If so, what might that be and why?
Stringent industry demands and requirements for quality and sterility in process have made disposable technologies a logical fit for biopharmaceutical production. As we see them expand from mainly upstream application into the downstream and fill/finish steps, it is probable that more types of manufacturing processes can now benefit from single-use technologies.
What do you see as the future for disposable technologies specifically regarding their adoption, materials of construction, and processing capabilities?
Adoption is already well underway, so now we have come to the point of maturing these technologies. As the industry comes together with regulatory bodies, it is likely that standards will be created to help advance the industry. And as single-use technologies come to maturity, processing capacities are greatly expanding. Where it was once a concept, we now see high-volume cGMP production with single-use technologies being implemented successfully.