Analytical Development & Product Characterization
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Analytical Development & Product Characterization
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Analytical Development & Product Characterization
Screening assays for Cell Line Development
Assessment of product Critical Quality Attributes (CQA)
In-process & product characterization
Risk Assessment to determine product CQA
Method development selects and optimizes analytical methods to assess drug attributes
Method verification / qualification (phase-appropriate validation) of release and stability assays follows FDA, ICH, & industry guidance as appropriate to ensure methods are fit for intended purpose
Method transfer to Quality Control for method validation
Verification is protocol driven following USP <1226> Verification of Compendial Procedures
| Method | USP | Methodology (Instrument) |
|---|---|---|
| Appearance (Visible Particles) | <790> | |
| Bacterial Endotoxin | <85> | LAL Chromogenic |
| Bioburden | <61> | Microbial Enumeration |
| Container Content (Extractable Volume) | <697> | |
| Osmolality | <785> | Freezing Point Depression |
| pH | <791> | |
| Sterility | <71> | |
| Total Protein Determination | <507> | A280 (Agilent Cary60) |
| Subvisible Particulates | <787>, <788> | Light Obscuration (HIAC 9703+) |
Qualification is protocol driven following ICH Q2(R2) & FDA guidelines
| CQA | Method | Instrument / Methodology |
|---|---|---|
| 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 Assay | 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 |
| 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 |
Ligand Binding Assays
Relative Potency Assays
Inhibition / Neutralization Assays
Plaque Reduction Neutralization Test (PRNT)
