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Comecer, Particle Measuring Systems (PMS) and the Italian Biochemical Institute (IBI) « Lorenzini » recently partnered to leverage and combine the expertise of each entity to design a new drug delivery system and a filling line to safely and effectively manufacture it. A Quality Risk Management (QRM) approach was used as the basis to meet the distinctive needs of the aseptic filling line and ensure that regulatory needs were met.
This partnership started when IBI designed a new approach to drug infusions deliveries, patented as “Espresso®”. “Espresso was created to ensure the safe delivery of sterile intravenous medication to patients”, said J. Khevenhüller, CEO at The Italian Biochemical Institute (IBI). “Following the initial project, we needed a way to safely mass produce Espresso. However, because of its unique design, existing filling lines could not meet our needs, so we contacted Comecer to create something new”.
“When Lorenzini approached us with their Espresso approach, we were immediately intrigued by the design challenges it presented. We took on the project to create something with a completely fresh approach to ensure the product sterility”, said S. Penazzi, Sales Area Manager Pharma Division at Comecer. “We had worked with PMS in the past and invited them to join our development team to leverage their industry knowledge”.
“Our Advisory Team has experience working with manufacturers to ensure they meet regulatory needs and to provide safe drugs to their customers, and we were confident our background could help solve the needs of the Espresso approach”, said Maurizio Della Pietra, Global Data Management Specialist and Process Advisor at Particle Measuring Systems. He continued, “Our insights to regulatory requirements, plus Comecer’s expertise in building filling lines, combined to create a forward-thinking, effective result”.
“As aseptic manufacturers develop unique new solutions, the requirement for increasingly complex manufacturing requirements to meet quality standards and to ensure the safety of drugs arises”, said Gianni Scialo, VP Pharmaceutical, Particle Measuring Systems. He continued, “Creative partnerships such as that between Comecer, IBI and PMS will become increasingly important to meet these needs« .