OR WAIT null SECS
Single-use solutions continue to grow in popularity, largely as a result of the cost and time efficiencies they can afford biopharma companies.
The market for single-use equipment within biopharma worldwide is expected to grow by a compound annual rate of 13.4% over the next five years (1). Growth in this market is expected to be driven by companies seeking more cost-effective solutions, the integration of single-use technologies in continuous processes, and the rapid advancement of biologics.
BioPharm International sat down with Johannes Kirchmair, managing director, Single Use Support; and Jon Van Pelt, general manager Bioprocess Single Use and Enterprise, GE Healthcare Life Sciences, to discuss the benefits, important considerations, and trends of single-use solutions in biopharma in more detail.
BioPharm: Single-use solutions have continuously increased in popularity over the years, could you elaborate on why these solutions are proving desirable and the benefits they afford users?
Van Pelt (GE Healthcare): The reality is that single-use is an established accepted platform within biopharma. The solutions afford biopharmaceutical manufacturers several benefits: The speed of changeover through the elimination of non-value-added steps, such as clean-in-place (CIP) operations or requiring sterilization-in-place, and the risk reduction of cross contamination between batches. These benefits translate into more efficiency and increased production capacity.
Kirchmair (Single Use Support): Single-use technologies address exactly the challenges the industry is facing with their development portfolio of products and in commercial manufacturing. During development, biopharma companies must be flexible with production floors potentially ready for a range of products and product classes. As a result of these requirements, single-use solutions prove beneficial because it is possible to mix several products in one set of hardware and it is possible to produce individual products cost-effectively.
Even if a company reaches the commercial scale, there is no guarantee that the product will perform once it is commercially available on the market. However, single-use solutions afford companies the flexibility to scale-up and scale-down production easily or use the same floor/set of hardware for another product if required. Furthermore, with a single-use contact surface, the number of qualification and validation exercises that are needed is reduced.
BioPharm: How can single-use solutions promote increased success for companies within biopharma?
Kirchmair (Single Use Support): Through single-use solutions, biopharma companies can enter the market relatively easily. For example, some suppliers of single-use solutions offer end-to-end solutions where it is possible to receive a prequalified set of products from seed to fill/finish. Moreover, the use of single-use solutions in the contract manufacturing organization (CMO) space can give rise to rapid turnaround times and, hence, reduced costs. In general, I believe that by using single-use solutions, barriers, such as cost to bringing a molecule to clinic and market, are lowered.
Van Pelt (GE Healthcare): Speed-to-market is often cited by companies using single-use technologies. Single-use promotes efficient utilization of production resources particularly with process set-up time at all scales of operation. The ability to design a process flow from cell expansion to purification in reduced time, rapidly scale up to clinical, then convert to commercial production are governing success factors. These factors also contribute to a more timely use of capital funds as companies go through clinical trials, reducing financial risk.
BioPharm: Are there pitfalls that companies should be aware of when looking to implement single-use consumables within biomanufacturing processes?
Van Pelt (GE Healthcare): Unlike stainless steel, where you buy and use, again and again, you are in an ongoing relationship with your single-use supplier. You should assure security of supply (issues such as financial stability, robust supplier quality, mapping of supply risk); quality (issues related to a robust quality management system-corrective actions and preventive actions management and complaint management), technical expertise (issues such as robust product development, materials understanding; and manufacturing (issues such as manufacturing workmanship, rigor, and capacity). You should also understand single-use workflows within your facility; you should account for the need for large enough storage facilities to house sufficient inventory and for the waste management needed to process the used materials. Training is very important, as without this, people commonly experience higher failure rates related to improper installation and use.
Kirchmair (Single Use Support): Personally, I would advise never getting locked in with one consumable provider, because if something goes wrong with the supply chain, you are trapped. However, there are regulatory challenges that need to be considered. Filing for commercial products needs to be well thought out, for example, so it is possible to switch your primary contact layer even during the commercial phase. In my opinion, the future will be with single-use [bag] provider agnostic platforms, such as a bioreactor hardware that can handle bioreactor bags from several providers, or a freeze/thaw platform that is able to handle bags from several suppliers.
BioPharm: What about waste management? Should companies be seeking extra measures in this regard?
Kirchmair (Single Use Support): Reusable systems are not really an option, in my opinion, but times are changing and environmental aspects should be considered by everyone, including the biopharma industry. In general, the environmental impact of single-use solutions is not too bad (several independent studies are showing that) but it’s still plastic! So, the suppliers have to help their clients to treat the waste properly to make sure that the impact is minimal. A global service platform to help companies manage waste would be an ideal solution-so, where waste is collected and treated in a professional way, similar to the disposal of confidential documents. This service platform could be an attractive business model and environmentally friendly at the same time.
Van Pelt (GE Healthcare): Sustainability is an area that has been on our radar for over 10 years. The first comparison of single use to stainless steel Life Cycle Assessment (“cradle to grave”) performed to the ISO 14040 standard concluded that single use was favorable from an environmental impact (2). The energy to fabricate reusable components and the utilization of thermal energy for sterilization and water for injection for CIP operations had a higher environmental impact versus single use.
However, the transport of single-use components is an area that should be studied more closely because transport is the largest contributor to the carbon footprint. Conversion of waste is another point for consideration. Plastic components, especially film, cannot be recycled other than as fillers for construction materials. Films are challenging because they are engineered composites of multiple layers consisting of different functional materials. Low extractable polyethylenes, oxygen barriers, tie layers all contribute to the final film that cannot be separated. Conversion to fuels is another possibility that is being pursued as a solution.
BioPharm: Is there any work being done to standardize single-use solutions?
Van Pelt (GE Healthcare): Participation between suppliers and biopharma working groups such as BioPhorum Operations Group, ASTM International, and British Pharmaceutical Students’ Association provide a forum and are actively moving toward standardization frameworks.
Kirchmair (Single Use Support): There are a lot of good ideas in place, but ultimately the variety of products is part of the single-use business model in the industry. Therefore, it is possible that there is not sufficient passion for standardization in industry. However, if there is an absolute need for standardization of single-use components, the pressure probably has to come from the end users to force it to materialize. Currently, it does not look like this pressure is coming. Standardization would lead to a smooth interaction between biotechs, the end-users, CMOs, and the suppliers. Obviously, standardization would be a desirable outcome as it would mean the industry would be able to collaborate more easily on a global scale.
BioPharm: What trends do you foresee as being important in single-use solutions in the near future?
Van Pelt (GE Healthcare): A series of cascading trends are on the horizon in the near and longer term. Short-term, sustainability through passive inventory management will be linked to cloud-based information transmission that facilitates predictive, staged shipments while minimizing wasteful transport. Mid-term, single-use on-line/in-line sensor technology will lead to connected processing enabled by smart process control. Finally, long-term, the data obtained will then evolve to predictive process control through artificial intelligence algorithms.
The single-use industry will be instrumental in helping biopharma customers accelerate their path towards delivering advanced therapies to market as quickly and cost effectively as possible. This trait is especially true in the emerging areas of cell and gene therapy. In addition to delivering flexibility in scale and speed in operations, single-use providers and biopharma customers will need to work on streamlining the consumable design space for improved efficiency.
Kirchmair (Single Use Support): Big trends that will impact single-use solutions in the near future include automation, increased robustness, elimination of manual interaction, scale-up of more commercial processes, cell and gene therapy products, and essentially the industrialization of the single-use operation. Fully automated, online monitored, consumable provider independent platforms will be the future. That’s a natural evolution.
Felicity Thomas is the European editor for BioPharm International.
Vol. 33, No. 4
When referring to this article, please cite it as F. Thomas, “Seeing Success with Single-Use Solutions,” BioPharm International 33 (4) 2020.