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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Process Example – Pluripotent Derived Cell Therapy 5

Open Process

Process Example – Pluripotent Derived Cell Therapy 6

X 1000’s

Closed Process

Technology Gaps – Raw Materials 7

Technology Gaps – Disposable Kits for Automation 8

Spike port Luer connection

Technology Gaps – Fluid Path Which welder? Which sealer? Which connector?

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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

info@ct.catapult.org.uk www.celltherapycatapult.org.uk