Quality Controls

Quality is the major concern at SB-PEPTIDE (c.f. Quality management). Production of hundreds very different peptides in parallel is challenging in terms of organization. The company has developed a Quality Management System to limit errors as best as possible, corrective procedures in case it occurs and a tracking system allowing to find every information on a peptide.

Quality Controls (QC) are a major tool to make sure about the compliance with project’s specifications. QCs  start at the beginning of the process with a double verification of the project specifications before entering in production. Then, multiple checkpoints (technical or documentary) have been defined to ensure every specifications are respected all along the process allowing prompt corrective actions if case of deviance. Final product quality controls are performed in a specific QC laboratory.

Included product quality controls

 Every individual peptides that are delivered undergone 4 final quality controls:

Mass spectrometry

MS allows to verify the identity of a peptide. Each amino acid sequence has a defined molecular weight. Using high-resolution MS system, can compare the theoritical molecular weight to the observed one to confirm the peptide identity. sb-PEPTIDE employs high-resolution ESI-QTof system to control peptide mass weight.

Liquid chromatography

HPLC allows to determine the purity rate of a target peptide. This quantitative methods allows to assess the proportion of every components of a solution and by consequent, the one of the compound of interest. sb-PEPTIDE employs analytical HPLC and/or LCMS system combined to highly-resolutive columns (i.e. 1.7 or 2.5µ).

Quantification

Peptide quantification is highly important, a reliable quantification allows reliable results. It is certainly the most complex quality control when done properly. At sb-PEPTIDE, amounts are given as « estimated net ». Contrary to « gross weight » quantification method where the peptide is simply weighted without considering salts (in average 20% of the weight), SB-PEPTIDE employs methods to quantify as best as possible the peptide amount and indicates the peptide amount (we don’t sale salts!).

Visual control

Final tubes are controlled visually to make sure lyophilization happened well and powder looks fine and similar between tubes.

Peptides are delivered with a certificate of analysis including every technical information (sequence, modifications, mass weight, purity rate, batch number).

Additional QCs available

In case a better characterization of the peptide, its impurities and environnement, sb-PEPTIDE offers a full range of analytical services.

• Couterion quantification  (TFA and/or acetate) by Ionic chromatography
• Sequence verification by MS/MS
• Water content verification by Karl Fisher method
• Quantification by Amino Acid Analysis
• Net Peptide Content determination by AAA
• Enantiomeric purity determination
• Endotoxin level measurement by LAL