Dr Andrew Rutter of GSK 'GSK's Progress to date on the business case for Primary Continuous

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Continuous Manufacture: Small Agile Factories Andrew Rutter Senior Director Check Step – Feedback on direction, Scope and Engineering Platforms Boundaries. GSK R&D, PTS Advanced June 2018. Manufacturing Technologies. A Rutter, J Jack, G Whelan


The old and the new co-exist for a long time‌.

2


Hit Rate, Phase II and beyond, since 2013

Type

Phase II

Phase III

File/Launch

Overall

Single Stage

0

3

0 for 3

> 1 SS could be MS

1

1

1 for 1

Multistage

0

1

1

1

1

1

2 for 3


We have a great technical solution?

Batch Feed

Gravity flow from feed to isolation Continuous line

Crystallisation

Filtration - Drying


Modular Design Concepts: Libraries of Unit Operations Modular building blocks to execute multiple Recipes

CBH l FEASIBILITY l Sponsor Meeting l 2017 April 18th l Business Use Only

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Technical Solution Engineering Platforms built for Precision and Agility Intensification through Continuous, Speed through Modularisation, Agile Compliance through Digitalisation and Advanced Control/Modelling Use in Space built for Agility Quickly move a line in and out. Build digital systems to automate compliance checks. Innovate on Control system modularity to follow library to speed automation deployment.

1

3

Assemble Modules to Production Line

Precision and Productivity Advanced Control Systems increasing productivity and compliance. Precise Output.

GMS campaign – Online UPLC 108 stacked chromatograms

2 Library of Unit Operations to Assemble to Recipe 2 Sizes – Small (10kg/day), Large (75kg/day). Designed to link Clinical and Launch Supply Reactors, Separators and Control Elements (pumps etc) 2 Environments – ATEX, non ATEX. Digital Twin to provide framework to link physical and digital world.

System Based Library of Models.

1 Presentation title

Drive speed and productivity of defining and exploring the design and operational space.

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3 Business Cases to Pursue…. Biopharm

“Straight Fight”, Capex Avoidance

CP Secondary

“Speed & Agility”, Sales, Speed to market

CP Primary

?

“Productivity”, Quality, Cash, Labour


Project Level Economics Simplified 10tpa of manufacture. ÂŁ800/kg Raw Materials. 3 Levels of applying Continuous Manufacture. Indicative only 6 Larger Scale stages requires multiple Modules to make volume

ÂŁ

More Intensification

2

10

10

1.5

9

2

8

6.7

1

6

2

6

5.3

0.8

5

=Bx Stage

=Continuous Stage


Factory Level

Depreciation

Maintenance People Raw Materials

Working Capital ‌To make 16 products


10 NCE’s, 1 per year

NCE 7

NCE 6

NCE 5

NCE 4

(1-4 stgs)

NCE 3

13 CP

NCE 2

30 stages

NCE 1

5 NCE’s

Totals (with and without CP) Legacy Bx New Bx Continuous


Conclusion Biopharm & Continuous Secondary have a simple/single platform. Business Case is Capex avoidance and Speed to Market. Continuous Primary is a more complex platform, covering large recipe diversity. Over time this will become easier to manage. Single Stage Application to simplify overall route. or Multistage for some projects (Capex or Working Capital). Longer play on Factory Productivity & Precision(>10 years)


Capital is dead labour, that, Vampire like, only lives by sucking living labour, and lives the more, the more labour it sucks. Karl Marx, Das Kapital Vol 1 Chapter 10.

“ One does not discover new lands without consenting to lose sight of the shore for a very long time� C Columbus


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