Solving aseptic filling challenges and smart contamination control
Industry magazines Pharmaceutical Manufacturing and Pharmaceutical Technology recently published articles about smarter contamination control and current aseptic filling challenges, respectively. Vanrx is featured in both articles, providing our perspective and solutions to help manufacturing leaders navigate the current landscape.
This article highlights the demand for working with small batches for personalized medicine, while maintaining aseptic integrity with contamination control.
“More companies [are] producing drugs that require containment, including cytotoxics, viral vectors and potent hormones,” Chris Procyshyn, chief executive officer of Vanrx Pharmasystems, says. “What these companies have in common is that the drugs are more targeted, creating the need for a higher number of small batches.”
According to Procyshyn, many of the current filling technologies are also not well-suited to the new manufacturing landscape that requires rapid batch changeover and containment on a smaller scale. To answer this issue, Vanrx has developed a gloveless robotic isolator.
This article addresses how robotics are being used to solve challenges around flexibility and aseptic assurance in manufacturing sterile injectables. Vanrx speaks to two main advantages to gloveless isolator technology.
Flexible and repeatable filling are becoming more crucial due to changes in the biopharma industry, notes Chris Procyshyn, CEO at Vanrx Pharmasystems. “The focus on targeted therapies for smaller patient populations creates a challenge for companies to produce a higher number of smaller batches into different container formats. Biologics, plus new modalities such as cell & gene therapies, are more complex and process intensive. The use of robotics is growing in response to these changes.”
A potential drawback to robotic systems is running speed. “These systems aren’t yet designed to run 500,000 unit batches or produce 100 million units a year. But that’s not where the demand is anyway, and conventional systems weren’t meeting the need for small batch flexibility,” says Procyshyn. “If a company is making high-value drugs into multiple formats or sizes, they want a robust, repeatable process that reduces risk. That happens best with a closed robotic filling system.”