Interview: Trends with Single-Use Bottles in Bioprocessing

One could read a lot about single-use bags in biopharmaceutical industry as a primary packaging in bioprocessing in the previous last years. The rise of bags has become more relevant, since they largely replaced single-use bottles. Nevertheless, sterile bottles still hold a significant share in the industry as primary packaging for biopharmaceutical manufacturing. Will they continue to do so? 
Khalil Essani, Technical Product Owner of Sterile Consumables at Single Use Support, has discussed the role of sterile bottles and their bottled potential in an interview.

Do you have any insights about the share of sterile bottles in the biopharmaceutical industry as primary packaging in manufacturing compared to single-use bags or others?

Khalil Essani: Bottles still hold a significant share in the biopharmaceutical industry. Without having a reference by hand I’d say that there are currently more single-use bottles than single-use bags in use. The fact that there are still so many bottles being used in bioprocessing has different reasons. One is that it is historically influenced. Another one is that the ecosystem and processes involved for bottles are optimized for various applications. And for some areas of application, bottles can be and will remain a legit choice. So, despite the rise of bags, bottles continue to be a preferred choice for many processes.

 
What are these areas of application where bioprocessing bottles are used?

Khalil Essani: Bottles are generally used for more robust products, such as media, buffer and DNA in small volumes. On the other hand single-use bags are to be preferred for more sensitive freezing applications, for example cell-based applications. So, bottles are largely used when adding buffer solutions or media to API. But there are also more robust biopharmaceutical products, such as monoclonal antibodies and ADCs, where it's conceivable that manufacturers still use bottles – even if single-use bags might be a better choice. As mentioned, the usage of primary packaging is often due to historical reasons. You don’t necessarily change a regulatory manifested process when the system still works satisfactory.  

 
Do you think that bottles would remain a popular choice or even be revived, if bottle processes were closed systems during fluid and cold chain management?

Khalil Essani: If the integrity of the closed system is ensured, I believe bottles could maintain their popularity and possibly even see a revival. EU regulations have addressed this pain point of manufacturers in Annex 1 to go towards aseptically closed systems. Therefore, the recommendation is to always prefer closed systems, and this could give bottles a boost, when they’re filled in automated closed process. However, there are several other factors to consider. For example, there have always been challenges with the sealing of bottles, which is a very critical point. Ensuring the integrity of the closure system is essential to prevent contamination and maintain product quality.

 
What are other trends and innovations you observe with regards to bottles?

Khalil Essani: There is a lot happening in this area. Sustainable bottle materials are becoming more important. There is a lot of research and development on making single-use packaging more eco-friendly. At Single Use Support, we are committed to improving fluid and cold chain management with bottles, in order to enhance product quality and process efficiency. We provide manufacturers and CDMOs with high-precision, modular filling processes and control over the freezing process for bottles. These efforts have culminated in an end-to-end process for biopharmaceutical products in bottles, ranging from automated filling, freezing, storing, and shipping, where bottles are protected safely throughout fluid and cold chain management. 
Overall, it’s encouraging to see bottles regaining relevance in bioprocessing: With the right technologies in place, there’s great potential to create new value. Perhaps it’s time to let the genie back out of the bottle.

 
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