Therapeutic development support for peptides — from feasibility through preclinical and clinical programs — with manufacturing support under ISO 13485 and GLP.
Built for therapeutic peptide programs that require stronger traceability, controlled analytics, and documentation support as you progress from feasibility to preclinical and clinical supply. Tell us your stage, peptide format, and documentation needs — we’ll align the workflow accordingly.
Inspired by “program stage” layouts used for therapeutic supply planning — adapted for peptides.
Illustrative development pathway for TX peptide programs (deliverables and controls are project-dependent).
Deliverables are project-dependent and aligned to your peptide format, scale, and documentation requirements.
A simple visual for how many peptide programs progress from early feasibility to therapeutic-grade development support.
Example progression from RUO feasibility to therapeutic-grade development support and controlled documentation.
Common peptide requests aligned to therapeutic development workflows.
Defined sequences with development-stage analytics and controlled documentation support.
Linkers, functional handles, and application-dependent modifications to support conjugation strategies.
Support for cyclic formats and stabilization strategies for demanding sequences.
Related materials and impurities to support method development and characterization workflows.
HPLC/MS verification and release package alignment to your requirements.
Batch records and traceability elements aligned to ISO 13485 and GLP support.
High-level comparison of typical expectations for RUO-grade vs Therapeutic (TX) peptide workflows.
Note: Specific deliverables depend on peptide type, scale, and project requirements. This page describes ISO 13485 and GLP manufacturing support for therapeutic development workflows.
Release documentation aligned to your requested requirements.
Purity profile and chromatogram output (as applicable).
Identity verification report for the delivered peptide.
Batch records and traceability elements designed for TX workflows.
“TX” refers to peptide manufacturing and documentation support intended for therapeutic development workflows. Deliverables are project-dependent and aligned to your stage (feasibility, preclinical, clinical) and documentation requirements.
Yes. Many programs require modifications (e.g., linkers or functional handles) and stabilization strategies. Share your design and goals and we’ll recommend an approach that fits your synthesis and analytics needs.
Documentation is project-dependent, but may include a CoA and analytical outputs (HPLC/MS), plus traceability elements and record retention aligned to ISO 13485 and GLP workflows.
Yes. We can discuss specifications, testing expectations, and documentation needs to support continuity across lots as your program progresses.
Provide sequence(s), quantity/scale targets, purity targets, labeling/modification needs, and any documentation or audit expectations. If you’re unsure, our scientists can help define the best path.
Common questions about therapeutic peptide development support, analytics, and documentation.
Share your peptide design, development stage, and documentation needs — we’ll recommend the right TX workflow.
Tip: If the peptide is hydrophobic/long/cysteine-rich or includes sensitive labels, mention it so we can route the request to the right synthesis strategy.
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