Manufacturing & quality
Manufactured to a standard you can audit.
Every SpecPep research material is synthesized, purified and released inside a documented U.S. cGMP quality system, with third-party testing and a Certificate of Analysis on every lot.
The production pipeline
Three phases. Eight controlled steps.
From qualified raw material to a documented, ready-to-ship lot. Nothing is skipped and no lot is released on assumption.
- 01
Raw material qualified
Incoming materials are identity-checked with a supplier Certificate of Analysis on file before entering synthesis.
- 02
Automated SPPS
Solid-phase peptide synthesis on automated synthesizers under controlled coupling cycles.
- 03
Cleavage & deprotection
Controlled conditions with a monitored reaction, followed by precipitation of the crude material.
- 04
Preparative HPLC
Purified by preparative reverse-phase HPLC to a ≥99.0% specification.
- 05
Fraction verified
Target peak collected and confirmed before the fraction is carried forward.
- 06
Lyophilization
Freeze-dried under vacuum to a stable powder with low residual moisture.
- 07
Fill, cap & seal
Vialed and sealed in a controlled environment, with fill weight verified within ±0.5% of label claim.
- 08
Batch record & release
Five-point QC panel run, lot-specific COA generated, batch record retained, lot released.
Release gating
A lot ships only after it clears every gate.
Release is a sequence, not a single check. Each lot must pass all of the following before it is eligible to ship. Fail any gate and the lot is held, investigated, and never shipped — only conforming lots reach inventory.
Browse the COA library ↗REVIEW
Verified against label claim within ±0.5%, batch-level quantification retained on file.
Cleared only after every preceding gate. Non-conforming material never reaches inventory.
Standards & accreditation
The framework behind the product.
Consistency at scale comes from systems, not luck. These are the standards our manufacturing and testing operate within.
U.S. cGMP manufacturing
Synthesized in a United States facility operating under current Good Manufacturing Practice controls.
Quality management system
Production runs inside an ISO 9001:2015 framework — controlled, documented and auditable end to end.
Documented traceability
Every lot carries a batch record and lot-specific COA, retained and available to partners.
Procurement-ready
Manufacturing you can put in a procurement file.
Documented process · Third-party testing · Lot-level traceability · COA on every lot · Same-day fulfillment
