Clinical Peptides & Peptide Pools
Clinical use peptides 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.
Why Choose JPT's Clinical Peptides?
JPT's peptides are produced under an ISO 9001:2015 certified quality management system, providing enhanced quality measures critical for clinical applications. Our production environment is designed to meet the rigorous standards required for immunotherapy, cell therapy, clinical immune monitoring, and vaccine development. We offer two specialized quality levels:
- ISO PLUS Peptides: Focused on immunotherapy and cell therapy, these peptides meet higher regulatory standards than those required for research use.
- Clinical Grade Peptides: These peptides adhere to the most stringent requirements and have been approved for a variety of clinical applications, including drug development and clinical proteomics.
Quality Control for Clinical Peptides
Our peptides undergo a comprehensive quality control process, ensuring that they meet the highest standards for clinical applications. Below is a comparison of our quality control measures:
| 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
Chemical & Physical Analyses for Clinical Peptides
- 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
Biological Testing for Clinical Peptides & Pools for Clinical Peptides
- 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
Bioinformatics & Cheminformatics for Clinical Peptides
- 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.
