BPOG Risk Based Approaches to Use of Closed Systems in Renovations of Existing Biopharma API Facilities

Companies often experience regulatory challenges during inspection of aging facilities, requiring them to initiate projects to optimize product protection and updating to current standards for classified areas for biopharma manufacturing. For a long time the company response have been to improve the existing classified areas or maybe even upgrading to a higher grade of classification. However, it may be more appropriate, and improve product protection, to instead implement the use of closed system processes and downgrade room classification during these facility renovation projects. If closed systems are fully utilised, then a CNC space can be used. As well as reducing complexity of operations, this will reduce capital and operating costs.
This presentation elaborates the work of BPOG members to harmonize the use of closed systems and define risk based tools and approaches to evaluate appropriate room classification across the Biopharmaceutical industry.
Presented by Lars Hovmand-Lyster, Senior Engineering Specialist in Novo Nordisk Global Project Office (GPO) Engineering Management Department
Senior Engineering specialist in Novo Nordisk Global Project Office (GPO) Engineering management department.
Quality Risk Management facilitator for product protection/closed Systems, contamination/cross contamination across Product Supply in Novo Nordisk.
Novo Nordisk Coordinator in BPOG Closed System in CNC work stream
Different positions at Novo Nordisk since April 2001 covering QC laboratory, downstream processing, design and qualification.
 
 
Sponsored by Merck
 

 
 
 
Merck is a leader in life science. Our purpose is to solve the toughest problems in life science by collaborating with the global scientific community – and through that, we aim to accelerate access to better health for people everywhere. We provide scientists and engineers with best-in-class products, technologies, services, and expertise. Our Mobius® range of single-use products enable faster, safer and more cost-effective manufacturing. From initial assessment of single-use alternatives to optimization of your single-use process, we deliver solutions for buffer and media preparation, cell culture, clarification, chromatography, virus clearance, ultrafiltration/diafiltration, formulation and final fill. At the heart of our Mobius® solutions are industry leading filtration and separation technologies including Durapore®, Millipore Express®, Millistak+®, Pellicon®, and Viresolve® Pro filters and Eshmuno®, Fractogel® and ProSep® Ultra Plus chromatography resins.
 
Followed by Ernest Jenness, Senior Product Manager for Mobius Single-Use Products at Merck
Ernie Jenness is a Senior Product Manager for Mobius Single-Use Products at Merck. Ernie joined Merck in 1990 holding positions in Manufacturing, Applications, Research and Development, and Product Management. His focus for the last 15 years has been in Single-Use systems. Prior to Merck, Ernie worked in the micro-electronics industry.
Ernie holds a BS in Mechanical Engineering and an MBA. He has published several articles related to Single-Use systems. He is a member of PDA, ISPE and BPSA.