— FL-04 · Tampa, Florida

Inside the
laboratory.

14,000 SQFT FACILITY
3 SPPS SYNTHESIZERS
2 RP-HPLC STATIONS
1 CLASS 100,000 CLEANROOM
34 ANALYTICAL CHEMISTS
N° 01 — The numbers

By the
numbers.

99.7%
2026 mean
HPLC purity
144/yr
Independent
third-party verifications
2-8°C
Cold-chain
maintained · 96-hr transit
0
Lots that have failed
verification & shipped
N° 02 — The process

From sequence to
sealed vial.

Solid-phase peptide synthesis

The peptide chain is assembled amino acid by amino acid on a polymer resin using Fmoc chemistry. Coupling efficiency is monitored at every step.

Cleavage & deprotection

Trifluoroacetic acid cleaves the assembled peptide from the resin and removes side-chain protecting groups. The crude peptide is precipitated and dried.

Reverse-phase HPLC

The crude peptide passes through a C18 column with a precision-controlled gradient. Pure fractions are collected; impurities are discarded.

Mass spectrometry

ESI-MS confirms the molecular weight of the purified peptide matches the theoretical mass within 0.1 Daltons.

Lyophilization

Purified peptide is frozen, then sublimated under vacuum to remove all water. The resulting white powder is stable for years at 2-8°C.

Sterile vialing

In our class 100,000 cleanroom, lyophilized peptide is weighed into Type 1 borosilicate vials, capped with butyl rubber stoppers, and crimp-sealed.

Endotoxin & sterility

Each vial undergoes USP <71> sterility testing and a LAL endotoxin assay. Bacterial endotoxin must read < 0.5 EU/mg to clear release.

Internal HPLC verification

A representative sample from every batch is rerun on HPLC by our internal QA team — independent of the synthesis chemist who produced it.

Independent verification

The same batch is shipped to ARC Labs (ISO 17025) for third-party HPLC analysis. Results must agree with our internal data within 0.2% tolerance.

N° 03 — The instruments

The tools.

Every instrument that touches a Uvie batch, calibrated quarterly, IQ/OQ/PQ documented.

N° 001
CEM Liberty BlueMICROWAVE-ASSISTED PEPTIDE SYNTHESIZER
3 UNITS · 0.005-5 MMOL SCALE
N° 002
Agilent 1260 Infinity IIRP-HPLC ANALYTICAL & PREP
2 UNITS · UV / DAD DETECTION
N° 003
Waters Xevo G2-XSQUADRUPOLE TIME-OF-FLIGHT MS
5 PPM MASS ACCURACY
N° 004
VirTis BenchTop ProLYOPHILIZER · 4-SHELF
−85°C · 26K BTU REFRIGERATION
N° 005
BioMerieux ENDOSAFELAL CARTRIDGE SYSTEM
15-MIN TURNAROUND · 21 CFR PT 11
N° 006
ESCO AeroCLASS 100,000 CLEANROOM
3,200 SQFT · ISO 8 CERTIFIED
N° 04 — The facility

Through the glass.

● REC · LIVEFL-04 / SYNTHESIS BAY
SPPS
SYNTHESIS BAY · 14:32:08
HPLC-02LIVE
HPLC
PURIFICATION · BAY 02
FILL LINECR-A
FILL
CLEANROOM · CR-A
— Visit

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walk-through.

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