Introduction
Accesing the GS Xceed™ Gene Expression System is easy. Under a Research and Evaluation Agreement (REA) we provide you with naïve untransfected CHOK1SV GS-KO cells, GS vectors, our chemically defined, animal component-free (CDACF) Media and Feeds System (v8), full protocols and regulatory reports for you to discover and develop any number of candidate proteins at the pre-clinical stages. Once you are ready to file an IND for a therapeutic candidate, a GS Commerical License must be obtained to cover the clincial development and commercial stages for the candidate drug.
Simply email us at GSLonza@lonza.com for information on how to obtain a GS-KO REA. The REA is renewable on an annual fee basis for as long as you have GS-expressed products in pre-clinical stages. This standard package can then be augmented with options to purchase additional proprietary technology together with the associated know-how.
GS Xceed™ Research Evaluation Agreement (REA)
The standard package of materials for GS Xceed™ REA holders is:
- Vials of GMP host cell bank CHOK1SV GS-KO
- GS vectors and sequence data
- Version 8 (v8) CDACF Media & Feeds System
- Technology updates
- In-house or on-site training
- Cell bank characterization reports to support regulatory submissions
- Comprehensive technical operating manual GS literature updates and newsletters
- Visits to customer sites as part of GS Xceed™ System tours
- Technical teleconference following 3 months of using the new GS Xceed™ System
- Access to technical support from Lonza’s experts via the GSLonza@lonza.com mailbox
GS Xceed™ Commercial License
Once a product has progressed to the stage of IND filing, GS Commercial Licenses (single or multi-product) must be obtained to allow for clinical development and commercialization of your product produced using the new GS Xceed™ Gene Expression System. The license should be in place by the start of human clinical trials. Licensees will often continue to hold a GS REA License along with a GS Commercial License, to allow for continued evaluation of new products in pre-clinical R&D stages.
Please contact us at GSLonza@lonza.com for more information on how to upgrade your existing GS REA to a GS Commercial License.
Optional GS Xceed™ System Packages
At Lonza, we value the concept of continuous advancement and innovation of our technologies. We encourage all of our GS Xceed™ Gene Expression System customers to augment their standard GS REA package by purchasing other proprietary components together with associated know-how. These additional packages allow you to obtain the maximum value of your expression system.
Optional Packages of the GS Xceed™ System Include:
- Constant Region Vectors
- Host Cell Protein Western Blotting Assays
- Host Cell Protein ELISA Assays
Epibase™ Server for Immunogenicity Risk Mitigation
- A customer specific server for customers to screen all their candidate sequences in house for potential immunogenicity using Lonza’s proprietary Epibase™ screening platform
- Automated T cell epitope prediction and report generation
- Near unlimited number of sequence submissions
If you have any questions regaring the new GS Xceed™ System, please contact Lonza’s licensing group at GSLonza@lonza.com.
