Peptides for Critical Raw Material Applications
Ensure Compliance & Reliability with ISOplus Peptides
At JPT Peptide Technologies, we offer ISOplus grade peptides, designed for use as critical raw materials in various applications. With our ISOplus peptides, you can ensure to meet regulatory guidelines for your clinical applications, such as GLP and ISO 13485. Our strict quality management and certified QMS ensure the highest standards of quality, traceability, and compliance.
Why Choose ISOplus Grade Peptides as Critical Raw Materials?
- Regulatory Compliance – Applicable for clinical applications meeting your requirements (e.g. for GLP and ISO 13485).
- Full Traceability – Comprehensive documentation, including CoA and stability data.
- Strict Quality Management – Certified QMS ensuring supplier qualification, batch records, and robust quality control.
Applications of ISOplus Peptides
Our ISOplus grade peptides are ideal for:
- Clinical Immune Monitoring – Reliable peptides for immunological assays.
- DMPK Studies – High-quality peptides for drug metabolism and pharmacokinetics research.
- IVD Reagent Formulation – Critical raw materials for in vitro diagnostic assays.
Critical Raw Material Peptide Production Capacities
- Milligram to Multigram Scale – Suitable for research and production needs.
- High Purity (>95%) – Ensuring superior performance.
- Up to 50 Amino Acids – Routine synthesis of long and complex peptides.
- Custom Packaging & Aliquotation – Tailored to meet your requirements.
- Wide Range of Modifications – Including isotope labeling, cyclization, biotinylation, and more.
- Extensive Quality Controls – LC-MS, MS/MS sequencing, NPC by AAA, endotoxin testing, bioburden testing, short & long-term stability testing with updated CoA.
ISOplus Quality Management
What is ISOplus? Designed to prevent cross-contamination with enforced conditions such as line clearance and single-use columns.
What Documents are delivered?
- Certificate of Analysis (CoA) with complete analytical results.
- Updated CoA for long-term stability after each retest.
- Short-Term Stability Reports under stress conditions for handling and storage guidelines.
Auditable Manufacturing: JPT operates under a certified quality management system and is fully auditable by customers.
Comparison between RUO vs. ISOplus Peptides: To the already very high standard of our research use only (RUO) peptides, we have added several specifications to make ISOplus the option for your critical raw material applications:
| Specification | JPT's RUO | JPT's ISOPlus |
| Incoming material inspection | x | x |
| Vendor qualification | x | x |
| ADCF policy | x | x |
| Certificate of analysis (CoA) | x | x |
| Document management & LIM-system | x | x |
| Line clearance | x | |
| Shipment control | x | x |
| Endotox-free | x | |
| Audits | x | x |
| Critical change control | x | x |
| Regular stability testing with updated CoA | x |
Why Choose JPT for Custom Peptide Synthesis?
- Industry Expertise: Over 20 years of experience in peptide synthesis for research, diagnostics, and regulated applications.
- Uncompromised Quality: Rigorous quality control ensuring high purity, batch-to-batch consistency, and reliable performance.
- Regulatory Support: Team of scientists supporting regulatory submissions and compliance requirements.
- Scalability: From small-scale synthesis to large-scale production, tailored to your project needs.
- Reliable Partner: Efficient production processes and a large peptide synthesis capacity to meet your timelines without compromising quality.
Get in Touch
Looking for high quality custom peptides for IVD or critical raw materials? Contact us today to discuss your requirements and receive a personalized quote.
Premium Grade Catalog Products for IVD & Critical Raw Materials
Our premium grade catalog products undergo rigorous testing for sterility, cytotoxicity and stability to ensure consistent performance.
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