Join us at ISPE Annual Meeting

Take part with us

We’re excited to present with our clients - AstraZeneca, United Therapeutics and Catapult Cell & Gene Therapy -

Monday, October 14th

10.45-11.15

Whole Life Carbon & Pharma Manufacturing

AstraZeneca (Gary Dugdale) + PM Group (Michael Keohane)

All new buildings will soon be required to estimate their whole life carbon emissions as part of forthcoming environmental legislation. Michael Keohane and Gary Dugdale’s presentation will provide an insight into the source of carbon in pharmaceutical buildings with case study findings on whole life carbon assessment of pharma manufacturing facilities. An overview of life cycle assessment (LCA) for carbon emissions will be provided including the challenges & design strategy opportunities for the construction of industrial buildings.

Michael Keohane is a Sustainability SME and LEED AP at PM Group

Gary Dugdale is Built Environment and Sustainability Lead, Global Engineering, AstraZeneca

 

11.15-11.45

ATMP Regulatory Collaboration & Organisational Readiness

Catapult Cell & Gene Therapy (Jon Halling) + PM Group (Alf Penfold)

Accommodating multiple modalities in the same facility is becoming an important requirement as seen during the COVID-19 pandemic when rapidly developing and launching new vaccines. In this presentation, Alf Penfold and Jon Halling will outline how multiple Advanced Therapy Medicinal Product (ATMPs) modalities have been successfully accommodated in the same facility. They will also look at the many other unique challenges associated with ATMPs.

Alf Penfold is Technical Director – GMP Regulatory Compliance at PM Group

Jon Halling is Managing Director for Quality, Catapult Cell & Gene Therapy

 

15.30-16.00

ATMP Facility Impacts on Cost of Goods

United Therapeutics (Erich Bozenhardt) + PM Group (Charles Heffernan)

In the rapidly evolving field of cell therapy manufacturing, companies are grappling with significant cost pressures as they strive to bring ground breaking therapies to market. A critical factor influencing these costs is the selection of manufacturing technologies, which directly impacts facility design requirements. This often includes the size and specification of cleanroom environments. Charles Heffernan and Erich Bozenhardt will delve into the financial implications of technology choices on the construction and operational expenses of manufacturing facilities.

 

Charles Heffernan is Director of Advanced Therapies and Biologics at PM Group

Erich Bozenhardt is a Bioprocess SME with United Therapeutics

 

Learn more about ISPE Annual Meeting and Expo 2024