Robotic Sterile Fill-Finish Manufacturing Services Reducing Time to First-in-Human Trials.

With nearly two-thirds of the early-development pipeline coming from small and emerging biopharma, there is a great need to accelerate programs into clinical trials and secure additional funding. At the same time, companies are seeking to de-risk manufacturing operations.

Robotic gloveless isolator sterile fill finish (SFF) systems address both of these needs. In discussion with Pharma’s Almanac Editor-in-Chief David Alvaro, Ph.D., three technical experts from PCI Pharma Services explain how the company supports the accelerated timelines of its client partners as they commence early-phase clinical trials with immediately available robotic SFF capacity at their clinical manufacturing and packaging facility in the United States.

About the Authors

Jerome Detreille Senior Director, Business Development, EMEA, PCI Pharma Services
After graduating from Strasbourg University of Pharmacy, France, Jerome spent 13 years as European Director of Business Development in Catalent for sterile injectables, before moving to Penn Pharmaceutical Services as Senior Director New Business Development in 2012. Here, he was part of the executive team who built the potent Contained Manufacturing Facility (CMF), which won the ISPE Facility of the Year award for Facility Integration (2014). In 2014, PCI acquired Penn Pharmaceutical Services, and Jerome continues to act as Senior Director of New Business Development to support the growth of PCI, especially in the development and manufacturing of sterile and lyophilized drug products.

Derek Truninger General Manager – San Diego, PCI Pharma Services
Derek Truninger is the General Manager of PCI’s San Diego Clinical Centre of Excellence. An experienced people leader with 13 years of experience at PCI Pharma Services. Derek spent eight years on the Commercial Quality side of our organization and has spent the last five years supporting the Clinical Services Team at our San Diego, CA location. Derek holds a B.S. in business administration and an MBA with an emphasis in business management from Rockford University. Derek has firmly positioned the San Diego site for continued growth and has played an instrumental role in our recent robotic sterile fill-finish expansion project at the San Diego site.

Peter Kim Senior Director, Quality Assurance, PCI Pharma Services
With over 18 years of experience in quality and operations roles, Peter Kim is presently serving as the Senior Director of Quality at PCI Pharma Services, a world leading CDMO. Before taking on his current role in 2023, he held the position of Head of Quality for Aprogen Biologics (South Korea CDMO) and served as the Operations Part Leader for Aseptic Fill Finish at Samsung Biologics. In these roles, he successfully led remediation efforts for worldwide approval and implemented operation excellence initiatives to drive organizational profit. Prior to that, Peter held manufacturing and quality roles with increasing responsibility at Pacira Pharmaceuticals, Dendreon, and Taekda (formerly Baxter Bioscience). He earned his B.A. degree in biology from the University of California, Berkeley.

Reducing Time to First-in-Human Trials with Robotic Sterile Fill-Finish Manufacturing Services with Jerome Detreille, Derek Truninger and Peter Kim | As seen in Pharmas Almanac | February 2024

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