ISPE DVC April Program: Single Use Technology Assessment & Implementation via Retrofit of a Clinical Manufacturing Facility

ISPE Delaware Valley Chapter - April Program - Single Use Technology Assessment & Implementation via Retrofit of a Clinical Manufacturing Facility

GlaxoSmithKline’s Clinical Manufacturing Facility in Upper Merion, PA was renovated to establish a global manufacturing platform strategy for scale out with 2000L Single-Use Bioreactors (SUBs). The latest advances in SUB technologies were assessed through qualitative and quantitative analysis, and compared to stainless steel systems. Renovations were completed and validated in 2016.

A global cross-divisional team completed a data driven approach to evaluate SUB technologies from multiple suppliers. Experimental data, computational fluid dynamics, vendor data analysis and operational assessment formed the framework for selection. SUB performance was compared to stainless steel bioreactors.

Single-Use systems were also introduced in the seed scale-up, media prep, sterile media hold and harvest filtration processes that will be harmonized with commercial manufacturing. The clinical manufacturing space will maintain a hybrid single-use/stainless process train for legacy products and flexibility.

Transformation of an existing clinical manufacturing facility proved challenging with the constraints of the existing building and avoiding a full facility shutdown. Construction personnel access, removal of existing equipment and installation of new systems was planned to minimize impact to ongoing GMP operations.

Learning Objectives:

At the conclusion of this session, participants will:

  • Understand a data driven approach for selection of technology from multiple suppliers
  • Understand how this project implemented a global cross-divisional team leveraging the data driven approach
  • Understand how a matrix framework was used to for decision analysis
  • Understand how this project provides a model for hybridization of an existing GMP operating facility

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Presenters

Steve Orichowskyj, PE, CPIP

Steve is Senior Director of Biotechnology for Hargrove Life Sciences in Philadelphia, PA. Steve has thirty years of experience in the biotech industry as a process development engineer, engineering consultant and project manager.  This includes domestic and international projects for start-up biotech companies and major biotech/pharmaceutical companies, as well as experience in the food, dairy and biofuels industries. Steve’s prior experience includes process development work with Lawrence Berkeley Laboratories, Hoffmann-La Roche and Microlife Technics.  Steve is a chemical engineer with a BS degree from Rutgers University in New Brunswick, NJ and an MS degree from the University of California, Berkeley. 

 

Edward Stevens

Ed is the Manager of Capital Projects, Biopharmaceutical Pilot Plant for GlaxoSmithKline in Upper Merion, PA. He has held various positions of increasing responsibility during his thirty years with GSK in support of areas including GMP production for clinical trials, process development for both cell culture and microbial products, and GMP anti-infective manufacturing. Ed holds a Bachelor's degree in Information Systems and an MBA, both from AIU. He has almost thirty-five years of industrial experience, including R&D experience in the both the pharmaceutical and semiconductor industries.  

 

Steve Comer

Steve is a Senior Technology Manager for GlaxoSmithKline in Upper Merion, PA. Steve has over thirty years of experience in biopharmaceutical manufacturing with both mammalian cell culture and microbial fermentation platforms. Throughout his career, Steve has accumulated expertise across most aspects of biopharmaceutical manufacturing through his experience in several roles, including production supervision, process technology transfer management, production scheduling and new technology introduction. Steve has a Bachelor’s degree in Microbiology from Clemson University.


Registration Information:

 

COST

ISPE Members

$60

Non-Members

$80

ISPE Young Professionals

$20

Student/Retired/Unemployed

Free

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Sponsors:

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Walk-in registrations will be permitted for an additional $20 per ticket price.