Cell and Gene Therapy Manufacturing workshop – Next generation manufacturing

The annual Cell and Gene Therapy Manufacturing workshop is being held this year at Guy’s Hospital, London, 14-15 March 2018.

The recent approvals of cell therapies such as Yescarta and Kymriah represent major milestones for the industry. However, these breakthrough therapies will initially only be delivered to a small number of patients. How will they be manufactured in large numbers? To achieve this, the industry must address bottlenecks in manufacturing, both scale-up and scale-out, as well as high cost-of-goods.

The theme for this year’s workshop is next generation manufacturing. The objective is to challenge delegates to think about the commercial product, market and process from the outset when developing a cell or gene therapy. Following the workshop delegates should be able to use this information to inform their process development and manufacturing strategy for clinical trials and routine manufacturing.

The workshop will include presentations from a wide range of experienced experts in the commercialisation of cell and gene therapies.

Date

14-15 March 2018

Venue

Guy’s Hospital, London

Agenda

Day 1

 

12:00-13:00

Arrival and networking lunch

 

13:00-13:10

Welcome

Julie Kerby and Dr. Stephen Ward, Cell and Gene Therapy Catapult

13:10-13:30

AMC latest data cell and gene therapy

Angela Osborne, eXmoor pharma concepts

13:30-14:00

Grand challenges

Dr. Phil Vanek, GE Healthcare

14:00-14:30

Flexible facility design

Jon Halling, Cell and Gene Therapy Catapult

14:30-15:00

Operational compliance of the future: Augmented reality

Mark Allen, GlaxoSmithKline

15:00-15:30

Break

15:30-16:00

Achieving market authorisation (what can go wrong at the last hurdle)

Dr. Alexis Cockroft, Lex Regulatory

16:00-16:30

Successful tech transfer

Dr. Daniel Smith, Cobra Biologics

16:30-16:50

Scale out manufacturing model

Chris Fisher, Autolus

16:50-17:20

In-line predictive technologies

Dr. Sam Watts, Stratophase

17:20-17:40

Central manufacture vs Near patient cost of goods

Professor Suzy Farid, UCL

17:40-17:50

Closing remarks

Julie Kerby and Dr. Stephen Ward, Cell and Gene Therapy Catapult

19:00-19:30

Networking drinks

London Bridge Hotel, 8 - 18 London Bridge Street

19:30

Dinner

London Bridge Hotel, 8 - 18 London Bridge Street

 

Day 2

 

08:45-09:00

Arrival, tea and coffee

 

09:00-09:10

Welcome

Julie Kerby, Cell and Gene Therapy Catapult

09:10-09:40

S.M.A.R.T.E.R. Manufacturing – Goal setting for the next generation

Dr. Ryan McCoy, Cell and Gene Therapy Catapult

9:40-10:10

Automated closed system production, process integration and scaling out

Dr. Ian Johnston, Miltenyi Biotec

10:10-10:40

De-risking supply chain: tracking and shipping

Alex Ricketts, Cryogatt Systems Limited

10:40-11:10

Break

11:10-11:40

Comparability for agile manufacturing

Natalie Ward, Cell and Gene Therapy Catapult

11:40-12:10

Paradigm shift in process control and release

Dr. Damian Marshall, Cell and Gene Therapy Catapult

12:10-12:40

Rapid alternatives to conventional sterility testing 

Dr Paul Newby, GlaxoSmithKline

12:40-13:40

Lunch

13.40-14:10

Raman applications in biomedical manufacturing processes

Dr. Brian McNeil, Strathclyde University

14:10-14:40

Skills academy – Task force update

Dr. Tony Bradshaw, Bradshaw Talent Management

14:40-15:00

Break

15:00-15:30

Scale-up manufacturing model – Viral Vector

Dr. James Miskin, Oxford BioMedica

15:30-16:00

Adeno-associated virus - Empty vs Full

Dr. Gregory Berger, Cell and Gene Therapy Catapult

16:00-16:30

Creating a purification platform process for viral vectors

Iwan Roberts, Puridify

16:30-17:00 Proof of concept study: Process development for AAV production Dr. Maya Fürstenau-Sharp, Sartorius Stedim Biotech GmbH 

17:00-17:15

Workshop closing remarks

Julie Kerby, Cell and Gene Therapy Catapult

 

We have now reached capacity for this event, however please get in touch if you would like to be added to the event waiting list.

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