Transcript The GS Gene Expression System™

The GS Gene Expression System™
The GS System™ is a widely accepted,
industry-leading expression system
Industry-Leading Expression System
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Owned and licensed by Lonza
A mammalian gene expression system
For therapeutic proteins and monoclonal antibodies
GS-CHO and GS-NS0 cell lines
Widely Accepted
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Over 110 companies, 75 academic institutions
Over 95 products in the clinic
100s of high-yielding cell lines created
(last 15 years)
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Principles of the Glutamine
Synthetase (GS) System
ATP
NH4+ + glutamate
ADP + Pi
glutamine
methionine sulphoximine (MSX)
MSX = a glutamate analogue that binds to GS irreversibly
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slide 3
The GS Gene Expression System™ is
accessible at all stages of production
Discovery
basic
research
disease
discovery
Development
drug
discovery
drug
development
Manufacture
Distribution
clinical
trials
packaging
production
marketing
sales
distribution
Lonza
Development
Services &
Manufacturing
GS vector
&
cell line
construction
cGMP
cell
banking
process
development
& scale up
cGMP
production
regulatory
support
Customer
In-Licensing
Lonza’s
GS Technology
GS vector
&
cell line
construction
cGMP
cell
banking
process
development
& scale up
cGMP
production
regulatory
support
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Using the GS System™ is proven to
improve yields and speed
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High-yielding
cell lines
Up to 9.6 g/L GS-CHO
1.9g/L GS-NS0 in chemically defined,
animal component-free medium
Speed
No need for rounds of gene amplification
Scale Up
Predictable (1 to 20,000L currently)
Regulatory
Acceptance
10 licensed products: Zenapax® (Roche),
Synagis® (MedImmune), Soliris® (Alexion),
& 5 mAbs, 2 protein
Ease of use
Complete support package
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Using the GS System™ leads to
higher product concentrations
Product concentrations for GS-CHO cell lines making different
antibodies in Lonza’s cGMP manufacturing bioreactors
Concentration (g/L)
ProductConcentration
Product
(g/L)
5
4
3
2
1
0
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The majority of products will achieve
more then 2g/L using the GS System™
Lines
Cell Lines
NumberofofCell
Number
Product)
DifferentProduct)
MakingaaDifferent
(Each
(Each Making
Product concentrations for GS-CHO cell lines making different
antibodies in Lonza’s cGMP manufacturing bioreactors
8
7
6
5
4
3
2
1
0
0-1
1-2
2-3
3-4
>4
Product Concentration
Concentration (g/L)(g/L)
Product
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200
100%
160
80%
120
60%
80
40%
40
20%
Relative Cost %
Number of Batches Required
Increasing productivity with the
GS System™ lowers relative cost
2000L scale
5000L Scale
Cost
Assumptions
0
0%
0.1
0.3
0.6
Product Titre (g/L)
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1.9
2.8
Product Requirement:
35kg/yr
65% yield across
purification
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The GS System™ is used for a number
of well-known commercial products
Zenapax™
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Roche - humanized antibody
Treatment of prophylaxis of acute
organ rejection in kidney transplant
rejection patients
Synagis™
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MedImmune - humanized antibody
Prevention of serious lower tract
disease caused by RSV (Respiratory
Syncytial Virus)
4 additional mAbs: Alexion’s Soliris® and 3 non-disclosed
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The GS System™ and out-licensing
team ensures your needs are meet
Arun Nataraj
Qingyu Cao
Director of Licensing & Technology
Sales
 +1 201 316 9485
 [email protected]
Licensing and Technology Manager
 +33 3 20 26 8738
 [email protected]
General
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Isabella Sharratt
Sales & Business Development
Administrator
 +44 1753 716 676
 [email protected]
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228 Bath Road, Slough SL1 4DX,
Great Britain
+44 1753 777 000
[email protected]
Online
 www.lonza.com
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The GS out-licensing package provides
timely, comprehensive support
Patents
Materials
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Standard 0.4 series GS vectors
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Host cell lines from cGMP cell banks
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NSO
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CHOK1SV
Transfection Medium System
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Our GS out-licensing package offers
access to years of specific know-how
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GS manuals: methodologies, equipment
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Vector sequences
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Regulatory support
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Vector information
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Characterization and testing status of host cell banks
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Support for media and feeds in regulatory submissions
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Working with Lonza’s proprietary media and feeds
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Technical updates; Support: [email protected]
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GS System Optional Packages /
Updates and Improvements
2011: GS-CHO Chemically Defined Animal Component
Free (CDACF) Live Version 8 Media System
2011: Light Path™ Discovery Material Supply
2011: Epibase™ Server for Immunogenicity Risk
Mitigation
2010: Genetic Characterisation Service
2010: pConPlus vectors
2010: Potelligent® CHOK1SV Cell Line Technology
2007: GS-NS0 and GS-CHOK1 Host Cell Protein ELISA
assay reagents and know-how
2006: GS-NS0 and GS-CHOK1SV Host Cell Protein
Western Blotting assay reagents and know-how
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Lonza also offers the GS System™
to customers for research purposes
Research Evaluation Agreement (REA)
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Commerical Customers
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any product – research use only
Annual fee: £35K
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The GS System™ license is designed
with a user’s needs in mind
Per Product
Required before start of clinical trials for therapeutics
Commercial terms linked to manufacturing source
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3rd Party manufacturing (CMO)
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Customer or Strategic Partner manufacturing
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£300k per annum and 2% royalties on net sales
£75k per annum due from Phase 2, 1.5% royalties on net sales
Lonza manufacturing
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License fees waived, 1.5% royalties on net sales
Term
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Royalties to patent expiry then 50% reduction to cover know-how.
Multi-product Licenses for using GS as a platform technology
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The GS System™ has been adopted for
licensed therapeutics at every stage
140
Number of Products
120
132
100
80
60
47
40
40
20
0
Pre-Clinical
Phase 1
Phase 2
10
9
Phase 3
Commercial
Phase of Clinical Trial
Notes
Total active licensed products: over 240
Total in active human trials / pre-registration: 100
Total approved: 9
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