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Nexus Pharmaceuticals Aseptic Facility: A Case Study in Bringing Pharma Manufacturing Back to the USA

May 25, 2022 | 10:00am and 1:00pm

Jacob K. Javits Convention Center - New York, NY

Come learn about this project, a first of its kind in more than 30 years, combining state-of-the-art isolator, lyophilization, vial and syringe filling technologies to provide a flexible, robust and operationally efficient US source for generic pharmaceuticals.

This project, the first of its kind in more than 30 years, combines state-of-the-art isolator, lyophilization, vial, and syringe filling technologies to provide a flexible, robust, and operationally efficient US source for generic pharmaceuticals. The facility allows Nexus to expand upon its current product portfolio and offers an impressive array of product presentations, including aseptically filled and terminally sterilized liquid products in vial, syringe, and cartridge formats as well as lyophilized vials. 

The facility itself features several key facility of the future design elements, including multi-story construction, 2-story lyophilizer configuration, and the use of bridge trusses in key process areas. These design elements allow master planning for seamless expansion of manufacturing and packaging capacities and will facilitate future area manufacturing upgrades or re-purposing to ensure ongoing facility relevance. The aesthetically focused utility concept projects these modern design features and will be a welcome addition to the technology hub in Pleasant Prairie, Wisconsin.  

IPS is pleased to have been selected by Nexus to participate in this exciting project along with the equipment vendor partners featured on this tour – namely Bausch+Ströbel, Franz Ziel, IMA, and Optima. The high level of cooperation evident throughout the project resulted in innovative solutions to common design issues.
  
Phase 1 of this multi-phase, multi-year project, which features a barrier isolator-based liquid/lyo vial filling line is complete. Phase 2 of the project, which features a barrier isolator-based syringe filling line, is underway; full campus buildout is expected over the next 10 years. Attend this case study to hear details from Nexus, IPS, and our partnering vendors about project challenges and solutions.

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  • Rob Roy, PE

    Director, Aseptic Technology - IPS-Integrated Project Services, LLC

    Mr. Roy offers over 30 years of dedicated professional experience in all phases of advanced aseptic processing, including engineering, quality, qualification, and manufacturing operations for the pharmaceutical and biotechnology industries. Rob has technical expertise in process mapping and optimization, barrier isolation technology, single-use disposable systems, potent material handling and containment, cleaning validation, and CIP/SIP systems.

    Mr. Roy offers over 30 years of dedicated professional experience in all phases of advanced aseptic processing, including engineering, quality, qualification, and manufacturing operations for the pharmaceutical and biotechnology industries. Rob has technical expertise in process mapping and optimization, barrier isolation technology, single-use disposable systems, potent material handling and containment, cleaning validation, and CIP/SIP systems.

  • Edward Flagg

    Project Director - IPS-Integrated Project Services, LLC

    Mr. Flagg has over 30 years of experience in the pharmaceutical and biotechnology industries. He has design and management experience in almost every aspect of this industry from almost every type of manufacturing capability to research and development with laboratories/facilities to quality control laboratories, clean rooms, pilot plants, mechanical plants, manufacturing, packaging, warehousing, and all support facilities, such as central utility buildings. Ed’s breadth of work has included projects in aseptic facilities, oral solid dosage facilities, liquid facilities, and creams & ointment facilities and product work for aseptic filling, live vaccine facilities, vivariums, DEA work, biohazardous areas, cell and gene work, potent product work, inhalation products, including the design of the associated utilities and support for these products.

    Mr. Flagg has over 30 years of experience in the pharmaceutical and biotechnology industries. He has design and management experience in almost every aspect of this industry from almost every type of manufacturing capability to research and development with laboratories/facilities to quality control laboratories, clean rooms, pilot plants, mechanical plants, manufacturing, packaging, warehousing, and all support facilities, such as central utility buildings. Ed’s breadth of work has included projects in aseptic facilities, oral solid dosage facilities, liquid facilities, and creams & ointment facilities and product work for aseptic filling, live vaccine facilities, vivariums, DEA work, biohazardous areas, cell and gene work, potent product work, inhalation products, including the design of the associated utilities and support for these products.

Jacob K. Javits Convention Center

10:00AM and 1:00PM

655 W 34th St | New York, NY 10001

The IPS Technologies Tours and Case Studies at Interphex will take place at the Javits Center. Please meet in the Glass Room at the Javits Center.

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