Mark A. Sitcoske, founder & CEO of High Purity New England (HPNE) explains the benefits of using single-use systems to scale up from development to full-scale production in biomanufacturing facilities.
Scale-up
The rapid transition from drug development to full-scale production is crucial for biopharmaceutical manufacturers to realise a return on their R&D costs. Speed to market requires the efficient scaling up of a manufacturing process—whether it occurs in the same facility or moves to a new one. The adoption of single-use systems (SUS), with their flexibility, portability, and ease of use, makes them the obvious cost-effective solution for scaling up. SUS accommodates increased demand, whether this occurs during development or only once full-scale production becomes necessary. Most importantly, incorporating SUS into R&D pilot processes makes it more efficient to scale up to commercial production.
The popularity of single-use bioprocessing solutions continues to grow, with the market in the biopharma industry projected to be worth $26.89 billion by 2025, with a compound annual growth rate of 13.6%. Replacing traditional bioprocessing equipment with continually improving single-use technology and the expansion of single-use manufacturing facilities by contract manufacturing organisations (CMOs) are key contributors to this growth. Demand is also being driven by its spread upstream and downstream into all areas of biopharmaceutical manufacturing, from research and development to fill-finish.
While the shift to SUS has revolutionised bioprocessing and manufacturing facilities, scaling up from discovery and development to full-scale manufacturing can be a challenge for biopharmaceutical manufacturers. Challenges include the need to design and implement a new process for commercial production that may differ from laboratory conditions. Fortunately, innovations in single-use systems equipment and processes, along with vendor partners who can design, engineer, and build a fully customised solution, are helping companies that are looking for solutions.
The following benefits of single-use systems add up to reduced infrastructure costs and more efficient bioprocessing.
Flexibility of single-use systems allows scale-up to commercial production
The flexibility of SUS allows a company to adapt a process so as to produce a new drug in the future. This means that progressing from R&D to full-scale production, or to the manufacture of a different product, can happen in the same facility.
As with traditional stainless-steel equipment, aseptic conditions and containment during production are essential to protect workers and the final product from contamination. However, while stainless steel technology follows industry-wide regulatory standards, the use of SUS equipment, such as bioreactor bags and connectors, does not yet have set regulatory guidance documents to follow. Complicating matters, many single-use manufacturers resist the use of inter-company connectivity, preferring to promote their parts and making it difficult to move to another supplier once a process is in place. This makes it imperative to find a partner that is willing to customise a solution—incorporating equipment from multiple vendors if necessary—that can fit directly into any process and can bridge the gap until a completely bespoke solution is available. Relying on a single vendor capable of providing engineering and design advice will ensure the compatibility of the components of single-use assemblies.
Single-use systems offer scalability to production volumes of 50L, 250L, and 500L as standard sizes, which can be useful to meet the rising demand for cell and gene therapies, like monoclonal antibodies. The ideal single-use mixing system is designed to perform liquid/liquid and powder/liquid mixing with a dispersion plate able to efficiently mix the most challenging buffer, media, and biopharmaceutical ingredients.
Streamlining cleaning validation
The evolution of single-use systems in sterile manufacturing has made them a simpler and cost-effective alternative for cleaning and validation of bioreactors and downstream processing equipment. Prime examples are processes that require many steps, such as chromatography and purification. Unlike traditional bioprocessing, during which each tank needs to be cleaned before reuse, SUS bypasses this requirement, thus reducing downtime and increasing productivity.
Lower risk of contamination
Cross-contamination is a problem associated with reusable processing equipment, including bioreactors, piping, valves, and mixers. The individual components of single-use processing are closed operating systems, protecting products within them and leading to a greatly reduced potential of contamination. Because they are disposable, single-use systems also eliminate the kind of cross-contamination that is associated with reusable equipment that must be cleaned and sterilised before re-use.
All leading to reduced infrastructure costs
These benefits—flexibility, no cleaning requirement, lower risk of contamination, and lower cost of disposable products—lead to substantial savings in infrastructure costs for manufacturers.
Transitioning to single-use systems, or expanding the current use of them, requires partnering with an experienced team that has technical and unit operations expertise—with bioreactors, purification, and chromatography equipment—across all processes from R&D to fill-finish. These specialists provide the knowledge that will customise the scale-up of processes and equipment to maximise efficiency and speed, mitigate risk, and help avoid costly errors.