GMP manufacturing
GMP Peptides
Custom and catalog GMP grade peptides are manufactured in our classified ISO7 Clean rooms, these peptides serve several applications such as in vivo diagnostic imaging, starting materials in biopharmaceutical manufacturing, ex vivo cell therapy and neoantigen.
A wide range of GMP peptide applications
GMP Peptides Specifications
By extending our long-standing RUO custom peptide expertise to GMP Manufacturing, we combine innovation with GMP grade reproducibility, traceability, and consistency. We provide flexible batch sizes from small scale to large scale manufacturing including synthesis, purification and lyophilization up to tailored QC releases.
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QC Testing Attributes
All of our GMP peptides follow a stringent QC process. We systematically check the basic peptide properties such as identity, appearance and purity but we also offer a large range of validated QC methods including water content determination, endotoxin and bioburden measurement, solubility testing and residual water or counter-ion content, among others.
Catalog GMP peptides
The only beta-Amyloid peptides on the market produced under GMP
Our collection of catalog beta-Amyloïd peptides is one of the largest in the world.
By merging our vast expertise of peptide chemistries with our solid background in quality systems,
we are the first provider to deliver GMP grade beta-Amyloïd peptides to the market.
- Added assurance for your high-profile projects
- Production process compliant with 21 CFR part 820 and ISO 13485
- Manufacturing in controlled areas under SOP’s, BR’s, with qualified equipment and staff
- Lot to lot reproducibility, consistency, and traceability
- Comprehensive QC testing and characterization
Testing of our GMP beta-Amyloid peptides goes beyond the standard Purity and Mass spectrometry, by reporting results for Bioburden, Endotoxin, Monomer, and Peptide Content.
- Mass Spectrometry
- Peptide Purity
- Amino Acid Analysis
- Peptide Content
- Endotoxin
- Bioburden
- Solubility
- Monomer Content
- Water Content