You've chosen Americas as your location.

To clear your location selection and return to IPS Global, click below.

Return to IPS Global

You've chosen Americas as your location.

Thank you for choosing a location. This will help us show you the information that matters the most to you.

Continue Change Selection

Emergent CDMO Case Studies: Project Design and Implementation of Two State-of-the-art Fill/Finish Technologies

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

Jacob K. Javits Convention Center - New York, NY

Discover new technologies that deliver large-scale yields in this case study on manufacturing therapeutics and vaccines for biopharma.

This tour will highlight the implementation and design of the groninger® FlexPro50 (non-viral) and groninger® INTEGRA (viral) fill/finish expansions at two Emergent CDMO manufacturing sites in Maryland, USA: Camden and Rockville. Tour topics include project execution by IPS and Emergent followed by the isolator-based aseptic fill/finish technologies implemented by solution providers: groninger, Franz Ziel, and SKAN.

Share this Case Study

  • Paul Valerio

    Director of Process Technology - IPS-Integrated Project Services, LLC

    Mr. Valerio’s diverse and highly valued skill set has developed over a two-decade career working in various roles at multinational pharmaceutical corporations and leading containment equipment manufacturers. A combination of strong technical ability, business acumen, interpersonal skills, and international experience makes him a solid asset for the clients he supports. Paul supports clients manufacturing sterile products in multiple dosage forms, through all stages of design and manufacturing, including master planning through detailed design phases, URS development, vendor management and FAT support, and technical transfer analysis.

    Mr. Valerio’s diverse and highly valued skill set has developed over a two-decade career working in various roles at multinational pharmaceutical corporations and leading containment equipment manufacturers. A combination of strong technical ability, business acumen, interpersonal skills, and international experience makes him a solid asset for the clients he supports. Paul supports clients manufacturing sterile products in multiple dosage forms, through all stages of design and manufacturing, including master planning through detailed design phases, URS development, vendor management and FAT support, and technical transfer analysis.

  • Dan Leorda, PE

    Vice President, Mid-Atlantic Region - IPS-Integrated Project Services, LLC

    Mr. Leorda has over 25 years of progressive management experience in the pharmaceutical industry. Dan’s experience includes program management, procurement, project cost tracking, TVD and IPD delivery. He has extensive experience in all aspects of projects, including project planning from concept through execution, scope development, logistics, budgeting, procurement, subcontracting, and problem solving, as well as developing contracts, proposals, schedules, and safety plans. Dan has successfully provided management and construction services on fast-track EPCMV projects ranging in value from $100,000 to $80M and has successfully led EPCMV project teams globally.

    Mr. Leorda has over 25 years of progressive management experience in the pharmaceutical industry. Dan’s experience includes program management, procurement, project cost tracking, TVD and IPD delivery. He has extensive experience in all aspects of projects, including project planning from concept through execution, scope development, logistics, budgeting, procurement, subcontracting, and problem solving, as well as developing contracts, proposals, schedules, and safety plans. Dan has successfully provided management and construction services on fast-track EPCMV projects ranging in value from $100,000 to $80M and has successfully led EPCMV project teams globally.

  • Nithin Stephen

    Director, Commercial Development, Drug Product - Emergent

    As Director of Commercial Development, Nithin is responsible for developing and executing the commercial strategy for Emergent CDMO’s Drug Product Business Line. He supports the sales and business development team’s efforts to acquire and serve new clients as well as expanding our work and strengthening our relationships with current customers. With deep expertise in drug product fill/finish services, commercialization, and portfolio management, Nithin offers clients valuable insights and perspectives on how to best optimize their portfolio and manufacturing process.

    Before joining Emergent, Nithin served as associate Director of Business Management at Pharmaceutics International Inc. where he managed the clinical and commercial drug product portfolio. For six years, he supported the R&D, project management and business development team at this Baltimore-based CDMO. Nithin holds a doctorate of pharmacy from the University of Maryland, Eastern Shore School of Pharmacy.

    As Director of Commercial Development, Nithin is responsible for developing and executing the commercial strategy for Emergent CDMO’s Drug Product Business Line. He supports the sales and business development team’s efforts to acquire and serve new clients as well as expanding our work and strengthening our relationships with current customers. With deep expertise in drug product fill/finish services, commercialization, and portfolio management, Nithin offers clients valuable insights and perspectives on how to best optimize their portfolio and manufacturing process.

    Before joining Emergent, Nithin served as associate Director of Business Management at Pharmaceutics International Inc. where he managed the clinical and commercial drug product portfolio. For six years, he supported the R&D, project management and business development team at this Baltimore-based CDMO. Nithin holds a doctorate of pharmacy from the University of Maryland, Eastern Shore School of Pharmacy.

  • Peter Dayrell

    Global Director, Project Engineering, Manufacturing Operations - Emergent

    As Director of Global Project Engineering, Peter is responsible for developing and delivering the corporate capital portfolio, strategic project oversight, and harmonizing capital project delivery methodologies across the Emergent organization. He supports the manufacturing operations and CDMO teams in the evaluation and delivery of new capabilities in capacities to support manufacturing strategy and business growth.

    Peter has 16 years’ experience with Emergent focused in the areas of project management, engineering capital delivery, manufacturing site and global capital portfolio management, and engineering and construction management team leadership. Peter holds a Bachelor of Science in Mechanical Engineering from Michigan State University and is a certified Project Management Professional (PMP®) with PMI since 2009.

    As Director of Global Project Engineering, Peter is responsible for developing and delivering the corporate capital portfolio, strategic project oversight, and harmonizing capital project delivery methodologies across the Emergent organization. He supports the manufacturing operations and CDMO teams in the evaluation and delivery of new capabilities in capacities to support manufacturing strategy and business growth.

    Peter has 16 years’ experience with Emergent focused in the areas of project management, engineering capital delivery, manufacturing site and global capital portfolio management, and engineering and construction management team leadership. Peter holds a Bachelor of Science in Mechanical Engineering from Michigan State University and is a certified Project Management Professional (PMP®) with PMI since 2009.

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.

View our full COVID-19 statement and procedures

Read Policy

Choose Your Location

To customize your experience, select an IPS region or country to view specific information based on your location.

  • Americas
  • United States
  • Canada
  • Brazil
  • All Other Countries

You’ve chosen as your location.

Thank you for choosing a location. This will help us show the information that means to most to you. Continue to the homepage to view featured projects, and happenings specific to your location.

Continue

We use cookies to personalize and enhance your experience on our site. Visit our Privacy Policy to learn more.