Accessing the GS System™

Multichannel pipetting of CHO cells
  • Introduction

    Accessing the GS System™ is easy.  Under a Research Evaluation Agreement (REA) we provide you with our standard vectors, nucleotide sequences, host cells, access to the components of Lonza’s CM25 transfection medium, GS instruction manuals and relevant regulatory documentation. This standard package can then be augmented with options to purchase additional proprietary technology together with the associated know-how.

    Once you are ready to file an IND for a therapeutic candidate, a GS Commercial License must be obtained to cover the clinical development and commerical stages of your drug candidate.

    Simply contact Lonza by e-mail at GSLonza@lonza.com and information about how to obtain a GS Research Evaluation Agreement (REA) will be sent to you.

  • Research Evaluation Agreement (REA)

    The current standard package of GS System™ materials for GS REA holders are:

    • GS vectors and sequence data
    • Vials of GMP host cell bank NS0
    • Vials of GMP host cell bank CHOK1SV
    • Transfection medium system
    • Comprehensive technical operating manuals
    • Cell bank characterization reports to support regulatory submissions
    • Access to technical support from Lonza’s experts via the GSLonza@lonza.com mailbox
    • GS literature updates
    • Technology updates
    • In-house or on-site training
    • Visits to customer sites as part of GS System™ tours
    • Technical teleconference following 3 months of using the GS System™
  • GS 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 clinical development and commercialization of your product produced using the GS System™.  The license should be in place by the start of human clinical trials.  Licensees, will often continue to hold a GS REA, along with a GS Commercial License, to allow for continued evaluation of new products in Pre-clinical and R&D phases. 

    Please contact us at GSLonza@lonza.com for more information on how to upgrade your GS REA to a GS Commercial License Agreement.

  • Optional GS Packages

    At Lonza, we value the concept of continuous advancement and innovation of our technolgoies.  We encourage all of our GS 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.

    The Current Optional Packages of the GS System™ Include:

    • Constant Region Vectors – pConPlus Vectors
    • Serum-free Medium, Supplements and Feed Systems
    • Chemically defined, Animal Component-free Medium, Supplements and Feed Systems
    • Host Cell Protein Western Blotting Assays
    • Host Cell Protein ELISA Assays
    • Methionine Sulphoximine Assays

     

    New Custom Material Supply Services

    In addition to the following services, we now offer a custom material supply service for your early discovery and development needs.  This new service called Light Path™ Discovery Material Supply is a pre-clinical material generation service where Lonza produces between 10-250 mg of purified protein using the GS System™. The objective of Light Path™ Services is to provide the customer with product materials suited for early stage development needs. This includes product lead screening, functional studies, structural analysis, and formulation studies, which will ultimately shorten your timelines to the clinic.

    Light Path™ Services Include:

    • Customer provides sequences
    • Transient / stable transfection method using Lonza standard GS vector and cell lines or customer provided cell lines
    • Purification using Protein A/G, other commercially available resins or customer method
    • Purified material, supernatant, expressing vectors (for GS REA customers)
    • Delivery timeline of 8-16 weeks depending on the number of products and quantity
    • No license fees
    • Low cost introduction to GS System™
    • GS REA customers receive a 10 % discount on the standard Light Path™ Discovery Service fee