Clinical Peptides & Pools
Clinical peptides and PepMix™ Peptide Pools are increasingly needed as an antigen source for clinical immune monitoring, diagnostics, cell therapy and vaccine development. The diversity of applications and regulatory requirements calls for a flexible, high quality soruce for your clinical peptides. JPT is that source with its outstanding know-how on peptide antigen formats, peptide specifications and formulation, peptide manufacturability and properties as well as critical analytical release testing and batch documentation guaranteeing smooth transition from research to clinical application.
Building on our ISO 9001:2015 certified quality management system JPT established an enhanced peptide production environment that adds critical quality measures to the standard RuO (research use only) production, which are mandatory for clinical peptides and peptide pools. Resulting quality levels termed ISO PLUS Peptides and Clinical Grade Peptides focus on the more stringent requirements of immunotherapy, cell therapy, clinical immune monitoring, clinical proteomics as well as vaccine & drug development and have been approved for a variety of clinical applications.
Quality Control for Clinical Peptides
| SPECIFICATION | ISO 9001:2015 RuO |
ISO 9001:2015 ISO PLUS |
ISO 9001:2015 Clinical Grade |
|---|---|---|---|
| Incoming material inspection | x | x | x |
| Vendor qualification | x | x | x |
| Dedicated raw materials | x | ||
| Order-dedicated personnel | x | ||
| ADCF policy | x | x | x |
| Certificate of analysis | x | x | x |
| Document management & LIM-system | x | x | x |
| Documented cleaning & calibration | x | ||
| Batch doc. & CoA (acc. IND) | x | ||
| Line clearance | x (process) | x (spatial) | |
| Optional: certified vials | x | x | x |
| Shipment control | x | x | x |
| Batch release | x | ||
| Optional: Additional QC methods | x | x | x |
| Optional: Impurity ID & qualification | Report only | Report only | Report only |
Disclaimer:
Peptides of Clinical Grade and ISO PLUS specification are designed, manufactured and tested under an ISO 9001 certified quality system.
Peptides and peptide pools are intented for in vitro and research purposes only. Any use beyond this intented use requires the explicit approval of the customer’s legislative and regulatory agencies.
The customer is obliged to obtain advice from local regulatory authority and shall be solely responsible to ensure that the products are suitable for customer’s particular use and that intented use will not infringe statutory law. JPT invites its customers to visit, inspect and audit its facilities to verify if peptides or peptide pools produced under Clinical Grade or ISO PLUS conditions are suited for a specific application.
Optional Chemical & Physical Analyses
- Peptide Purity Determination
- Peptide Molecular Weight Determination
- Peptide Sequencing
- Peptide & Building Block Structure Confirmation
- Peptide Solubility Testing
- Peptide Stability Testing
- Peptide Quantitation / Peptide Content Determination
- Amino Acid Composition
- Residual Solvent (e.g. DMF, Acetonitrile, DMSO, NMP…) Determination
- Residual Water Determination
- Residual Counter-Ion (e.g. TFA, HCl, HOAc) Determination
- Enantiomeric Integrity
Learn more about all our Peptide Analysis Services: Chemical & Physical Analyses and which assays call for additional analyses.
Optional Biological Testing for Clinical Peptides & Pools
- Bacterial Endotoxin Testing
- Peptide Sterility Testing
- Cell Toxicity Testing
- Bioburden Determination
Learn more about all our Peptide Analysis Services: Biological Testing and which assays call for additional testing.
Bio- & Cheminformatics
- Manufacturability Evaluation /Ranking
Learn more about Peptide Analysis Services: Bio- & Cheminformatics and our proprietary Manufacturability Algorithm to predict potential difficulties and rank a given set of peptides according to their overall manufacturability.
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Quality Assurance
All production is ISO 9001:2015 certified.