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| We produce bulk quantities of all recombinant proteins. |
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 At Globe Labs we have the capability to produce large scale pre-clinical materials for animal and toxicology studies. Materials for pre-clinical studies do not need the operation of full cGLP manufacturing procedures.
It is frequent for sponsors to use materials obtained from Process Development projects for pre-clinical testing. All materials produced during development work are the property of the client and will be delivered to the sponsor upon request. Depending on the stage of product development or product characterization, release specifications and criteria will be outlined in the Process Development Scope of Work Agreement.
The Process Development Team at Globe provides assistance in clone selection and development of a suitable upstream and downstream manufacturing process for the production of pre-clinical materials. The principle objective is producing sufficient quantities of pre-clinical materials while meeting mutually agreeable specifications, therefore limited process development work will be applied unless specified by mutual agreement. Cell lines entering Globe must first be tested for presence of contaminants.
Globe offers the following services for pre-clinical manufacturing:
- Clone selection
- Process Development – upstream and downstream
- Analytical Development
- Scale up
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