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| We produce bulk quantities of all recombinant proteins. |
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Globe Labs has the resources to perform the majority of the release testing required for bulk protein development. The few tests which we require to be outsourced are carried out by our audited sub-contractors. At Globe our core expertise is in protein manufacturing and analysis.
Overview of Globe activities
- raw material testing - amidites, supports, reagents, solvents
- in-process testing - synthesis, cleavage/deprotection, purification
- final API testing
- environmental monitoring
- support for R&D, Process Development, troubleshooting
- stability testing
Typical API release tests include:
Identity
Molecular weight
Sequencing
PS/PO content |
Quality
Sodium content
Moisture content
Endotoxin Bioburden |
Purity
HPLC (IEX, RP)
CGE
Residual solvents limit
Trace metals limit |
Strength
Assay |
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