May
12
2021
On demand

Applying Warp Speed lessons to your ATMP manufacturing facility

Many of the life sciences trends that are driving innovation today were here pre-COVID, but the pandemic was an accelerant. This is true of the vaccine research that is moving at rapid speed to curb this acute global crisis, but it doesn’t stop there. The same tide is lifting all areas of the life sciences industry. This is particularly true for advanced therapy medicinal products. 

The pandemic is pushing the envelope on speed-to-market to the point that facility design and construction may be experiencing a paradigm shift. The tried-and-true approach needs to be revisited as Operation Warp Speed is demanding the biopharmaceutical industry to navigate uncharted territory. 

During this webinar, we will highlight lessons learned from a Warp Speed project and provide advice and new approaches on how to apply these lessons to the future of ATMP manufacturing.

Attendees will learn about:

  • Challenges and solutions from a COVID-19 Warp Speed project 
  • Code, safety and regulatory considerations to keep your project on track 
  • Practical advice to apply as the future of our industry navigates a paradigm shift 

James P. Bornholdt

Director, SlateXpace Technical Operations, CRB

Licensed as both an architect and an engineer, JP has extensive experience in the design and construction industry. He specializes in project management, facility integration and process architecture. His experience encompasses facility design for biotech and pharma, domestic and international CGMP regulatory, process design and development, project management, HVAC design, advanced energy modeling and construction administration. JP’s combined knowledge of multiple disciplines provides a strong basis for integrated facility design. His ability to conceptualize and communicate these ideas in real time is valued by the clients he serves.

Charles Heffernan

Senior Process Specialist, CRB

Charles has more than 20 years of biotechnology industry experience extending to business strategy development; technology strategy; facility and process equipment design; capital projects; process development; technology transfer; commissioning and qualification; new product introduction; technology management; and regulatory licensure and compliance. The processes and facilities he has designed include those for vaccines, mAbs, blood fractionation, plasmids, viral vectors, cell therapies, and gene-modified cell therapies including novel RNA-based processes.

Thomas Page

Associate Vice President of Engineering and Asset Development, FUJIFILM Diosynth Biotechnologies

Thomas Page, PhD is currently the Associate Vice President of Engineering and Asset Development at FUJIFILM Diosynth Biotechnologies. Dr. Page has a PhD in Chemical Engineering and Bioengineering from Rice University and brings more than 20 years of experience in process engineering, facilities design, and management.

His experience includes successfully devised and implemented the Engineering and Production strategy to support regulatory approvals in the U.S., EU, Russia and South Africa for several large volume parenterals. Previously he lead design efforts on next generation mobile clean room and directed the design and construction of the Pandemic Influenza Facility and the Live Virus Manufacturing Facility.

Jarrod Wrampe

Design Project Manager, CRB

Jarrod has over 18 years of experience as a process utility engineer and project manager at CRB. Jarrod’s experience as a design lead and project manager allow him to understand the entire project from inception to completion across multiple disciplines, making him an integral part of every phase of the design team. Jarrod is a subject matter expert for critical utilities including high purity water systems, process steam systems, liquefied and compressed gas systems, waste kill/neutralization systems, and process heat transfer systems.

SPEAKERS

James Bornholdt
Director, SlateXpace Technical Operations at CRB
Charles Heffernan
Director at CRB
Thomas Page
Vice President - Engineering & Asset Development at Fujifilm Diosynth Biotechnologies
Jarrod Wrampe
Process Utility Engineer at CRB

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