Your science is unique, your aseptic filling needs are not

Following an extensive research project carried out by Vanrx, we have found that pharmaceutical manufacturing experts – whether they are working on process engineering, development, or at an executive level – agree that even though their science is unique, their aseptic filling needs are not. Yet many still find themselves building custom aseptic filling systems. They admit this creates problems and increases risk. But what if there was a solution?

Adopting standardized technologies that use robotics and automation increase control over the aseptic process. This simplifies and reduces the costs associated with filling while removing the need for operator intervention and mitigating the chance of human error. The risk placed on the company is greatly reduced. 

Customization = higher risk

Your science is ground-breaking. Your drug products are life-changing and you care most about serving patients. Vanrx was founded by pharmaceutical manufacturing experts who have stood in your shoes. But did you know that your peers are saying that your aseptic filling needs are not as unique as you think?

Our research has shown that redesigning and building custom systems for each new drug product actually creates more challenges and limitations for filling operations. Unnecessary setbacks, overspending, and product losses can all impede vital drugs getting to the patients that rely on them. 

Then there is risk – the greatest challenge created by customization. The majority of respondents reported feeling that the burden of risk fell on their company, not the machine manufacturer, when developing custom technology. This increased uncertainty and a lack of automation lead to a higher chance of contamination, but is this a risk you’re willing to take?

What are the consequences of risky custom aseptic filling solutions?

Reducing risk with standardization

So if aseptic filling needs are not unique, is there a solution? The answer is yes. Our respondents revealed that there are two key aspects to developing optimal aseptic filling operations – one is removing the complexities and costs of a custom solution, and the other is removing the burden of risk that is placed on the biopharmaceutical company. Standardization does both of these things. 

Adopting standardized technologies that use robotics and automation increase control over the aseptic process. This simplifies and reduces the costs associated with filling while removing the need for operator intervention and mitigating the chance of human error. The risk placed on the company is greatly reduced. 

Created by experts, standard solutions are fast and simple to install so filling operations can get up and running without delays. The robust manufacturing technology is designed based on data, not opinion, with risk of contamination designed out of the process. The system has been validated by leading biopharmaceutical companies like FUJIFILM Diosynth Biotechnologies, Amgen and Roche/Genentech. Their science is revolutionary, but that doesn’t mean their filling needs are too.

What are leaders really looking for in manufacturing technologies?

More than half are looking for a robust manufacturing technology solution that is based on data, created by experts, and validated by other companies in their industry.

The virtuous cycle of automation

A standardized robotic solution creates what is described as a “virtuous cycle” of automation and reduced risk. The use of advanced robotics creates more control over the filling process. This results in less human error which then leads to less contamination of the drug products. Reducing the risk of contamination ultimately means lower costs associated with error and faster time to market. 

The vast majority of respondents—86%—found the idea of implementing a virtuous cycle of automation into their operations appealing to reduce risk.

At Vanrx, our goal is to make this virtuous cycle the new standard. We believe in shifting the risk to the experts and drawing on years of experience in the design and development of pharmaceutical manufacturing systems to create standardized, fully automated solutions that deliver greater control and speed while reducing risk. So what is standing in your way?

“Any innovation like this helps us stay state-of-the-art, which is what we want for 1. patient safety and 2. regulatory compliance.”

Manufacturing process developer
Major biopharmaceutical company