End-to-end solutions for biopharma bottles: increase efficiency and reduce risk

The concept of end-to-end solutions is transforming industries with a focus on seamless and efficient processes. For biopharmaceuticals this includes the drug substance handling with filling, freezing/thawing and transporting sensitive drug substances by using a streamlined and compatible platform. With single-use bottles, it's been only siloed solutions that weren't working together as one process.

Fluid management with rigid containers

To cover the entire process from A to Z, the biopharma industry has so far been confronted with bottles from various suppliers. However, if the process involves different providers the risk of incompatibility, product loss or damage caused by human error increases. This is also a reason why biopharmaceutical bottles were not filled using an automated and aseptically closed system. Single Use Support has addressed this problem and accomplished the last missing link of end-to-end solutions for biopharma bottles.

What is special about it? The end-to-end process applies independently from pharma bottle manufacturers. Meaning, you can use it no matter what bottle size or type you're using. Furthermore, it is modular and compatible to previous and following manufacturing process steps. This does not only mean a streamlined workflow with single-use technologies and consumables, but also with services such as qualification, documentationa and validation and after-sales service.

Challenges of manual bottle handling in biopharma

Manual bottle handling in biomanufacturing leads to many risks. It is slow, prone to human error, and has a high risk of contamination. These factors can jeopardize product quality and safety, making it challenging to scale up production. This is also the main reason why Annex 1 has emphasized to aseptically close the fluid path. Due to the time required manual bottle filling has also shown to be ressource intensive: it takes more time for more operators to fill bottles.

Why manual bottle filling puts biomanufacturers at risk

Aseptic filling as the last missing link of end-to-end bottle solutions

To maintain product integrity and increase efficiency, closed and automated systems are crucial. For optimal results and to minimize risks throughout the entire workflow, a comprehensive end-to-end solution is necessary. Single Use Support meets these challenges and revolutionizes not only end-to-end solutions for single-use bags but also for single-use bottles. The RoSS.FILL Bottle is an aseptic single-use bottle filling system that enables automated filling and filtration of your liquid drug and non-drug substances into bottles. The bottle filler can fill dozens of bottles of up to 10 L with highest filling accuracy.

Bottle assemblies for aseptic filling

Single Use Support has ISO7 cleanroom capabilities to produce single-use assemblies, including bottle assemblies for asepticaly closed filling of bottles. These can be customized in order to become off-the-shelf standardized sterile consumables.

The major advantage of end-to-end solutions for bottles is that all process steps are carried out by only using a single platform. Companies in the biopharmaceutical industry are thus able to work flexibly and efficiently. Moreover, they benefit from independence from manufacturer, scale, size, and single-use components.

Single Use Support can provide manufacturers and CDMOs with end-to-end process solutions for both primary packaging, single-use bags and single-use bottles. Its modular design enables scalability and process flexibility to cope with small or large volumes. This also facilitates a switch from single-use containers to single-use bags or working with both simultaneously. Thus, a positive effect on storage space and costs can be achieved.

Optimizing your workflow with Single Use Support's integrated platform 

Single Use Support offers an elaborate platform for single-use containers and bags that covers the entire process from filling and filtration to freezing/thawing and shipping. Unlike stand-alone silo platforms, this approach addresses specific manufacturer and laboratory requirements.

Single Use Support provides the following end-to-end solutions for bottles:

• IRIS bottle assemblies: Connect your bottle with tubing, connectors, and more
• RoSS.FILL Bottle: Closed bottle filler for drug substances
• Bottle.RoSS: Protect tubing on your single-use bottle
• RoSS.BLST: Controlled blast freezer for pharma bottles to freeze & thaw
• RoSS.ULTF: Temperature-controlled storage to maintain cold chain
• RoSS.SHIP: Protect your bottles for transportation at sub-zero temperature

It is high time to let go of said silo mentality that still dominantes many areas and industries. It is time to increase rationalization processes and to eliminate the risk of product loss. This will help biomanufacturers and CDMOs to increase efficiency and reduce risk in fluid and cold chain management significantly.

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