INTERPHEX 2026: The Multimodal Future of Sterile Manufacturing
Automation and living contamination control strategies are helping to answer some of industry’s most pressing sterile manufacturing challenges, explains Dr. Laura Moody from Syntegon.
As industry sharpens its focus on personalized medicine and orphan drugs, manufacturers are being required to adapt to the new process requirements of these more niche drugs. For example, filling lines not only need to remain sterile, but they also need to accommodate more frequent changeovers with the smaller volume drug products being manufactured.
In terms of the physical architecture of filling lines, there is a trend toward smaller equipment and a greater amount of automation, specifies Dr. Laura Moody, Director of Product Management Pharma, North America at Syntegon. “We’re also seeing a high instance of isolators being requested as they provide superior sterility assurance,” she says.
“So, equipment vendors are focusing not only on reducing the number of format parts, but also improving the ergonomics of the changeover tasks in an effort to speed this process up,” Moody continues. Through these changes, manufacturers can achieve increased equipment uptime and greater overall equipment effectiveness (OEE), she remarks.
Additionally, more robotics are being implemented into processes, replacing manual elements, Moody notes. “Not only does more robotics improve repeatability, but it also reduces the risk of contamination associated with human operators,” she says.
Minimizing potential contamination risks is a key aspect of the contamination control strategy (CCS) outlined within the revised European Union GMP Annex 1 guidance (1), which has been in force for a few years already. However, common mistakes around the implementation of the CCS are still being made by companies.
“We often find that people are selecting barrier technologies, either isolators or restricted access barrier systems, also referred to as RABS, for convenience rather than risk profile or ergonomics,” Moody asserts. Furthermore, some within the industry are “treating the CCS as a static compliance document instead of being a core living driver of facility design decisions,” Moody specifies. “An example of this is having cleaning access or EM [environmental monitoring] placements not designed into the overall process,” she states.
The upcoming INTERPHEX event, taking place in New York City between April 21–23, provides companies with a forum to discover new solutions that enhance manufacturing, development, regulatory compliance and supply chain efficiency. “What I love about INTERPHEX is the variety of different project conversations,” Moody summarizes. “One minute, I could be talking about a project for personalized medicine, the next minute, I find myself in a deep dive discussion about antibody drug conjugate containment strategies, only to switch gears in the next conversation to discuss high output vaccine production. It’s exciting to be able to provide answers to our partners in depth on all of their different manufacturing questions.”
Syntegon will be exhibiting at this year’s INTERPHEX conference at stand #1719.
Click the video above to view the full interview
Reference
European Commission. EU GMP Annex 1: Manufacture of Sterile Medicinal Products. EudraLex Volume 4, Aug. 22, 2022.
About the Speaker
Dr.Laura Moody is Director of Product Management Pharma, North America at Syntegon, with a focus on pharmaceutical liquid packaging for fill/finish applications and isolator technology. She has more than 20 years of experience in life sciences with roles in both academia and industry. Laura earned her Ph.D. in cellular and molecular biology at the University of Wisconsin–Madison and worked with aseptic antibody, vector, and cell manufacturing for many years before joining Syntegon in 2018. She is an active member of ISPE and PDA, volunteering with ISPE and a frequent speaker at international conferences.
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