BioPharm June eBook: Single-Use Systems

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16 BioPharm International eBook June 2018 Feussner (Vetter): With regards to new products, we have started to see an ever-increasing number of biologicals entering the clinic and, eventually, the market. This is largely due to continuous advances in discoveries of how the human body works. Many of these biologics are actually quite novel drug sub- stances that are focused on indi- vidual treatments targeting smaller markets, for example, orphan drugs. As such, the so called 'blockbuster' dr ug model that was common within the industry until just a cou- ple of years ago is no longer valid. Today, the direction is clearly t o w a r d h i g h l y s p e c i a l i z e d medications. This new focus on specialized drugs is ref lected in the clinical pipelines of biotech companies and includes quite a number of drugs that are highly s p e c i f ic to a s m a l le r p at ie nt population. Hand in hand with this is the technological aspect, which means that smaller patient size inevitably leads to smaller batch sizes in production. Thus, flexibility t a k e s o n a n e v e r- i n c r e a s i n g important function. This is also why today's drug product manufacturers must have in place the right approach to fulfill quality requirements and achieve regulatory compliance as well as have available the right manufacturing technology to sup- port and serve their customers' product strategies. Hull (Emergent BioSolutions): There are always new components and materials being introduced by the various vendors. Disposable bag systems, new aseptic connectors, custom fill line assemblies, and other components are items we see and use every day in our opera- tions. Nothing in particular stands out as new and exciting that has been introduced in the past year, but the vendors are always improv- ing their designs and introducing new offerings. DRIVERS TOWARD SINGLE-USE BioPharm: What are the key advantages and challenges to using single-use sys- tems for biologic fill/finish? Feussner (Vetter): We are aware of several aspects that must be taken into consideration when choosing the right technology, particularly con- sidering factors such as the type of medication and the complexity of the necessary equipment. On a case-by- case basis, these aspects can either be seen as an advantage or a challenge. One key factor is timing. To dem- onstrate this point, we need to look at how parameters such as procurement time or possibly needed cleaning validation time can differ between stainless-steel and single-use equip- ment. This type of equipment, in the best-case scenario, requires a purchase time of only a few weeks. By compari- son, with stainless-steel, the upfront time needed before filling includes the purchasing time itself as well as time needed for initial equipment qualification. Taken in total, this can result in much longer timeframes. As such, the time difference can some- times result in real savings. Another aspect is purchasing cost. For single-use equipment, the investment cost is typically much lower, with costs increasing as batch size increases. However, one cannot forget about costs created after their usage. The utilization of single-use equipment generates high destruction costs as they are considered hazardous waste. A third aspect that must be men- tioned, and one which is also central in order to select the right technol- ogy, is the field of drug characteris- tics and requirements. That means the individual project and product characteristics as well as process requirements that must be consid- ered. On the project side, parameters, such as batch size and compound- ing volume, are decisive as are the number of needed batches in project phase and batches expected in com- mercial phase. Looking at the prod- uct and process side, factors, such as choosing the right equipment to meet a product's light and oxygen sensitivity as well as its cooling needs in compounding stages, are crucial. Also, one must consider any special requirements for mixing and stirring. Additional risks also exist regarding E&L arising from the components of single-use systems, owing to any potential effects on final quality and safety of the drug product. This impact has to be fully verified in a detailed manner as well. A further aspect includes supply chain management subjects with single-use technology. These are, for example, either shelf-life issues or the need for available stock equipment due to short-term demand increases. As such, it is appropriate to say that there does not exist a 'one-size- fits-all' solution. This is why biotech companies, together with their part- ners throughout the supply chain, do good by searching for the best solu- tion in their particular situation—in order to achieve a safe, flexible, and fast manufacturing process. Hull (Emergent BioSolutions): As a CMO fill/finish operation, we enjoy three key advantages from single- use technologies: time, money, and space. We can get clients into the cleanroom quicker using existing sin- gle-use components instead of hav- ing to wait to order dedicated tanks and pumping systems. We also spend less time preparing these items as many of them come pre-sterilized and ready for use. Money—these single-use bulk manufacturing systems and fill line assemblies are readily available from a variety of manufacturers and offer significant savings for clients at start-up by eliminating the cost of purchasing Single-Use Systems Fill/Finish

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