The GS Gene Expression System™
The GS System™ is a widely accepted, industry-leading expression system 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 Over 110 companies, 75 academic institutions Over 95 products in the clinic 100s of high-yielding cell lines created (last 15 years)
Principles of the Glutamine Synthetase (GS) System ATP ADP + Pi NH4+ + glutamate glutamine methionine sulphoximine (MSX) MSX = a glutamate analogue that binds to GS irreversibly
The GS Gene Expression System™ is accessible at all stages of production Discovery Development Manufacture Distribution basic research disease discovery drug discovery drug development clinical trials production packaging 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
Using the GS System™ is proven to improve yields and speed 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
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 Product Concentration (g/L)
The majority of products will achieve more then 2g/L using the GS System™ Product concentrations for GS-CHO cell lines making different antibodies in Lonza’s cGMP manufacturing bioreactors Number of Cell Lines (Each Making a Different Product) Product Concentration (g/L)
Increasing productivity with the GS System™ lowers relative cost Assumptions Product Requirement: 35kg/yr 65% yield across purification
The GS System™ is used for a number of well-known commercial products Zenapax™ Roche - humanized antibody Treatment of prophylaxis of acute organ rejection in kidney transplant rejection patients Synagis™ 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
The GS System™ and out-licensing team ensures your needs are meet Arun Nataraj Director of Licensing & Technology Sales +1 201 316 9485 arun.nataraj@lonza.com Isabella Sharratt Sales & Business Development Administrator +44 1753 716 676 isabella.sharratt@lonza.com Qingyu Cao Licensing and Technology Manager +33 3 20 26 8738 qingyu.cao@lonza.com General 228 Bath Road, Slough SL1 4DX, Great Britain +44 1753 777 000 GSLonza@lonza.com Online www.lonza.com
The GS out-licensing package provides timely, comprehensive support Patents Materials Standard 0.4 series GS vectors Host cell lines from cGMP cell banks NSO CHOK1SV Transfection Medium System
Our GS out-licensing package offers access to years of specific know-how GS manuals: methodologies, equipment Vector sequences Regulatory support Vector information Characterization and testing status of host cell banks Support for media and feeds in regulatory submissions Working with Lonza’s proprietary media and feeds Technical updates; Support: GSLonza@lonza.com
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
Lonza also offers the GS System™ to customers for research purposes Research Evaluation Agreement (REA) Commerical Customers any product – research use only Annual fee: £35K
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 3rd Party manufacturing (CMO) £300k per annum and 2% royalties on net sales Customer or Strategic Partner manufacturing £75k per annum due from Phase 2, 1.5% royalties on net sales Lonza manufacturing License fees waived, 1.5% royalties on net sales Term Royalties to patent expiry then 50% reduction to cover know-how. Multi-product Licenses for using GS as a platform technology
The GS System™ has been adopted for licensed therapeutics at every stage Notes Total active licensed products: over 240 Total in active human trials / pre-registration: 100 Total approved: 9