Catapult is a Technology Strategy Board programme
Technology gaps in developing closed systems for the manufacturing of ATMPs
Sarah Callens Head of Process Development ATMP Manufacturing Community 06 February 2014 ct.catapult.org.uk
Overview
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• What is closed processing?
• Why should you close a process?
• Example of the development of a closed process
• Technology gaps in closed processing
• Getting involved
What is closed processing?
Closed processing allows production to remain aseptic without relying on background and processing air quality.
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Why close a process?
• Reduces risk of contamination introduced by operators
• Decreases risk of cross contamination and can improve segregation
• Reduces COGs • Allows multiple products to be manufacturing within
the same manufacturing suite. • Allows processing in a Grade D (or C) background
rather than Grade B. Gowning, airlocks, facility flows, HVAC, plant space, EM requirements, cleaning.
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Technology Gaps – Scale down models
Closed systems for scale-down • Novel centrifugation • Lateral motion bioreactors • Stirred bioreactors.
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Stirred platform
Process Development Closed Systems and IPC Capability
15 FTE
1.7M budget 2013
Fill Finish
Wash, Volume Reduction, Formulation
Cel
l Exp
ansi
on
In Process Control
Cubian XC
Peregrine Automated Manual
Quantum®
Rocking platform
Vi-CELL
KSep SciLog TFF
Akta TFF
Pod system 12
Build in process efficiencies and reduce “non-value” added time by configuring the production environment to each process.
Process Development Organogram
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Sarah Callens
Head of Process Development
Ilaria Schena
Process Development Scientist
Vacancy
Process Development Scientist
Vacancy
Process Development Scientist
Evangelia Rologi
Process Development Technician
Asiya Arshad
Process Development Technician
Vacancy
Process Development Technician
Michael Delahaye
Senior Process Development Scientist
Leanne Partington
Senior Process Development Scientist
Ryan McCoy
Senior Process Development Scientist
Henrieta Fraser
Senior Process Development Scientist
Vacancy
Senior Process Development Scientist
Reginald Ugbeyan
Process Development Scientist
Jahid Hasan
Process Development Scientist
Jasmin Baboo
Process Development Scientist
Recruitment of Manufacturing Team
• Recruitment of the rest of the team through Q1-2 2014
• Initial focus on GMP Lab Manager and Manufacturing Scientists
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Head of Manufacturing
Phil Bassett
GMP Laboratory Manager
Outsourcing Manager
Logistics Manager Damian Grantham
Manufacturing Scientist
Outsourcing Scientist
Outsourcing Scientist
Manufacturing Scientist
Manufacturing Scientist
Em
bedded at C
MO
s
Catapult is a Technology Strategy Board programme
Current vacancies in the manufacturing team at the Cell Therapy Catapult Manufacturing Scientist The purpose of this role is to provide GMP manufacturing support for novel cell therapy medicinal products for Cell Therapy Catapult. Manufacturing Proving Lab Manager The purpose of this role is to routinely manage the ‘Manufacturing Proving Lab' and deliver manufacturing demonstration batches for novel cell therapy medicinal products at the Cell Therapy Catapult Outsourced Manufacturing Manager The purpose of this role is to routinely manage the transfer of projects and knowledge between the ‘Manufacturing Proving Lab' at Cell Therapy Catapult and external GMP production facilities. For more information and to apply please visit www.catapult.org.uk/careers
Catapult is a Technology Strategy Board programme
Industry
Cell Therapy Catapult
Investment
Researchers
NHS
[email protected] www.celltherapycatapult.org.uk