The rapid growth of biopharmaceuticals -peptides, oligonucleotides, monoclonal antibodies (mAbs), mRNA Vaccines, gene and cell therapy drugs has been in the focus for the past couple of years. Following the same trajectory, earlier this summer, the FDA advisory committee voted to recommend approval of seven additional peptide products: BPC-157, KPV, TB-500, MOTS-c, Epitalon, and Semax for the 503A bulks list drugs. This does not yet mean that these new medications are available to patients, but it is clear indication that the interest and availability of peptide drugs is growing and attracting attention from patients, industry, and regulators alike.

Scientech Laboratories has advanced mass spectrometry capabilities for characterizing peptides by LC-MS,LC-MS/MS, and other methods. Scientech has experience with analytical development which includes novel method development for your specific peptide followed by method validation to produce FDA cGMP-compliant data to support product release. Scientech can test both bulk drug substance and formulated drug product.

Scientech also has capabilitiesfor testing the safety of your peptide drug product to make sure it is free of undesired contaminants. We regularly test for heavy metals by ICP-MS, Residual solvents by GC and GC-MS, Microbial contamination USP <61> &<62>, endotoxin USP <85>, and other impurities.

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