Instrumentation & methods

Forty-plus platforms. One disciplined operating model.

Our analytical floor is built around redundant chromatography, mass spectrometry, spectroscopy, and microbiology platforms—qualified, calibrated, and operated under a single quality system.

Analyst loading sample into Agilent UHPLC stack for peptide characterization — FIG—07 · Peptide characterization · Agilent 1290 / Q-TOFVS-LAB-02

PLT—01

Chromatography

High-resolution separations for identity, potency, and impurity profiling.

Agilent 1290 Infinity II UHPLC(×3) DAD, FLD, RID
Waters Acquity H-Class UPLC(×2) TUV / PDA
Shimadzu Nexera X3 LC(×2) Method development
Thermo Vanquish Horizon UHPLCCharged Aerosol Detection
Agilent 7890B GC / FID(×2) Residual solvents
Thermo TRACE 1310 GC / TCD-FIDVolatiles & gases

PLT—02

Mass Spectrometry

Quantitative and structural confirmation across small molecules, peptides, and metals.

Sciex Triple Quad 6500+ QTRAPQuantitative LC–MS/MS
Thermo Q Exactive Plus OrbitrapHigh-resolution accurate mass
Agilent 7250 GC-QTOFUntargeted screening
Agilent 7900 ICP-MSElemental impurities, USP <232>/<233>
Bruker rapifleX MALDI-TOFPeptide & protein ID

PLT—03

Spectroscopy

Orthogonal structural and quantitative confirmation methods.

Bruker Avance NEO 400 MHz NMR1H, 13C, 2D experiments
Thermo Nicolet iS50 FTIRATR & transmission
Agilent Cary 3500 UV-VisMulti-cell kinetics
Horiba FluoroMax-4 FluorimeterSteady-state fluorescence
Malvern Mastersizer 3000Particle size distribution

PLT—04

Microbiology & Bioanalytics

Class II BSCs, dedicated BSL-2 suites, and rapid microbial identification.

bioMérieux VITEK 2 CompactMicrobial identification & AST
bioMérieux BacT/ALERT 3DSterility testing
MilliporeSigma Steritest SymbioMembrane filtration
Bio-Rad CFX Opus 96 qPCRPathogen detection
Thermo MSC-Advantage Class II BSCs(×6) BSL-2 suites
Memmert IPP & ICP incubatorsValidated temperature mapping

Compendial & regulatory methods

A reference library built around the methods regulators expect.

USP <61> / <62> Microbial Enumeration

USP <71> Sterility

USP <232> / <233> Elemental Impurities

USP <467> Residual Solvents

USP <621> Chromatography

USP <1225> Method Validation

USP <1226> Verification of Compendial Procedures

ICH Q2(R2) Validation

ICH Q3D Elemental Impurities

AOAC 2015.01 Heavy Metals

EP 2.6.12 / 2.6.13

FDA BAM Pathogen Methods

Reference materials are traceable to NIST, USP, EP, and Cerilliant. Method validation follows ICH Q2(R2). Full method lists and validation summaries are available under NDA.