Pearl River Laboratories (PRL) provides a wide range of phase appropriate analytical services to the pharmaceutical and biopharmaceutical industry. We are a fully compliant 21CFR part11 laboratory meeting your cGMP analytical testing needs from Phase1 through commercial. PRL takes pride in meeting customers needs through high quality, customer focus, flexibility and innovation.

GMP Assays

General Assays

• Appearance (Coloration)

• Appearance (Clarity)

• Appearance (visible particulates)

• Protein concentration (UV)

• pH

• Density Determination

Chromatography-Based Assays

• Aggregation by SEC

• Distribution by HIC

• Drug Conjugate ratio by UV, HIC, RP

• Free drug & related species by RP-HPLC

• CEX

• Peptide mapping profile

• Glycan Fingerprinting

• Methionine oxidation

Charge-Based Assays

• cGE (reduced, Beckman-Coulter 800 Plus)

• cGE (non-reduced, Beckman-Coulter 800 Plus)

• Charge Isoforms (iCE)

Colorimetric Assays

• MBTH

• Anthrone

Other Assays

• Endotoxin

• Moisture content

Heightened Characterization Assays

• Peptide mapping

• Glycan Fingerprinting

• Methionine oxidation

• Degradant characterization

• Forced Degradation studies

• NMR (1D, 2D, etc.)

• LC-MS-MS, MALDI for large molecule

Compendial Testing

• USP/NF

• EP

• JP

• ACS

Impurities Isolation, Identification and Characterization

Method Development, Qualification and Validation

• HPLC assays, including stability-indicating assays

• Charge-based assays (cGE, iCE)

• Chiral HPLC assays

• GC-FID methods for residual solvents

• GC-MS, LC-MS methods for potential genotoxic impurities (PGI’s)

• Counter Ion methods by titration & HPLC

• Customizable assays

• Specialized assays

Extractables and Leachables

• Development of Extractables and Leachables (E&L) methods (Volatile, Semi-Volatile and Non-Volatile)

• Risk Assessment studies for equipment, containers and closures

• Assess for (E &L) using established protocol studies for Biologics and Medical Devices undergoing Stability evaluation