Analytical Development & Quality Control

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Analytical Method Development

Comprehensive Analytical Services

Compendial, Physicochemical, & Biomolecular, and Characterization Analytical Methods

Address product Critical Quality Attributes (CQA)

In-process & product characterization

Regulatory Compliance

Method development follows FDA & ICH guidance

Method verification / qualification (phase-appropriate validation) of release and stability assays

Ensure methods are fit for intended purpose

Method transfer to Quality Control

Method Validation

Compendial Methods

Verification is protocol driven following USP <1226> Verification of Compendial Procedures

Method USP Instrument / Methodology
Appearance <790>
Total Protein Concentration by A280 <507> Agilent Cary60
Endotoxin <85> Charles River Endochrome-K™
pH <791>
Subvisible Particulates <787>, <788> HIAC 9703+

In-House Analytical Methods

Qualification is protocol driven following ICH Q2(R2) & FDA guidelines

Agilent 1100 & 1200 HPLC/UPLC

SCIEX PA 800 Plus

CQA Method Instrument
Charge Profile cIEF SCIEX PA 800 Plus
CEX Agilent 1290 UHPLC
Identity CEX Agilent 1290 UHPLC
Purity CE-SDS, Non-Reduced & Reduced SCIEX PA 800 Plus
SEC-HPLC Agilent 1290 UHPLC
Potency Cell Based Liquid N₂ Freezer, CO₂ Incubators, Cell Counter,
Plate Shakers, Washers,Readers
Binding ELISA Plate Shakers, Washers, Readers
Impurity Column Leachates ELISA
Residual Host Cell DNA 7500 FAST qPCR
Residual Host Cell Protein ELISA
Residual Cell Culture Supplements ELISA
Residual Simethicone Agilent 1260 HPLC – CAD
Content PS-80 Agilent 1260 HPLC – CAD

Characterization Methods

CQA Method Instrument
Content Amino Acid Analysis Agilent 1100 HPLC
Copy Number 7500 FAST qPCR
Function Binding Kinetics by Biolayer Interferometry Octet Red384
Structure & Post Translational Modifications Peptide Mapping Mass Spec & Agilent 1290 UHPLC
Intact Molecular Weight Mass Spec & Agilent 1290 UHPLC
Subunit Molecular Weight Mass Spec & Agilent 1290 UHPLC
N-Glycan Profile Mass Spec & Agilent 1290 UHPLC – FLD

Sartorius Octet Red384 System

Agilent 6545 XT Q-ToF Mass Spectrometer

Quality Control

Release Testing

cGMP testing to ensure product quality, efficacy, & safety

Compliance with USP & EP compendia, client-specific methods

Qualified and calibrated instrumentation with robust data integrity systems

Comprehensive analytical testing of raw materials, in-process samples, finished product, and stability samples

Microbiological testing capabilities to support both DS and DP requirements

Stability Testing

Real-time and accelerated stability protocols with secure, monitored storage

ICH-compliant stability testing across all climatic zones

Forced degradation studies

Personnel Expertise

Experienced personnel with strong technical knowledge and operational efficiency

Experienced in supporting regulatory filings, and successful audits and inspections

Collaborative interaction with method development team ensuring transferrable and validateable methods

Quality Control : In-house Release and Stability Method

In-House Release

Quality Attribute

Method

Color, Clarity, Visible Particles-

Appearance

Total Protein Concentration -

Concentration by A280

pH-

pH

Safety-

Endotoxin, Subvisible Particles

Volume-

Extractable Volume

Potency -

Relative Potency ELISA

Purity-

Reduced CE, Non-Reduced CE, SEC-HPLC

Charge Profile and Identity -

CEX-HPLC

Impurities / Residuals-

Host Cell Protein ELISA, Protein A ELISA,Host Cell DNA PCR,Simethicone

Excipients-

PS80 HPLC-CAD

In-House Stability

Appearance

Concentration by A280

pH

Subvisible Particles

Relative Potency

Reduced CE

Non-Reduced CE

SEC-HPLC

CEX-HPLC

PS80 HPLC-CAD

Dedicated QC Staff

Effective AD/QC method transfers and support

Qualified methods for Phase 1/2 GMP

QC Process