What’s the difference between the R&D Systems’ research use only protein vs. GMP for manufacturing?
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GMP Proteins for Cell Therapy Manufacturing
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The main differences come down to extensive documentation, training, oversight, and added testing. GMP proteins include Quality Assurance reviews on all GMP batch and bottling records before release. Three validation lots are made before the product is released to ensure our ability to produce consistent lots. Validated equipment and methods are used throughout production. Our documentation extends to employee training, material traceability, equipment logs, and lot specific certificates of analysis. Each batch is tested for mycoplasma, host cell protein, and N-terminal sequencing of the first 10 amino acids. In addition, individual GMP bottlings also have additional bioactivity and bioburden testing. This is all done to ensure the production of safe and consistent proteins.
This post is sponsored by Bio-Techne.