Assay Platform |
Example Assays |
Equipment / Instrument |
Cell Based |
|
Potency |
MD/M5e; PE/Envision; MSD/S600; Beckma/Vicell; Labconco/A2; Thermo/ 3111 |
|
Mycoplasma |
UV Nano 5; PCR Instrument |
UPLC |
|
UP-SEC
|
Agilent/1290
Waters/H-Class |
|
Peptide Mapping |
Agilent/1290
Waters/H-Class |
|
N-glycans |
Agilent/1290
Waters/H-Class |
HPLC |
|
SEC |
Agilent/1260, 1290
Waters/E2695, Arc Bio
Thermo/Ultimate 3000
Shimatzu/LC-20AR |
|
CEX |
Agilent/1260, 1290
Waters/E2695, Arc Bio
Thermo/Ultimate 3000
Shimatzu/LC-20AR |
|
Titer by ProA |
Agilent/1260, 1290
Waters/E2695, Arc Bio
Thermo/Ultimate 3000
Shimatzu/LC-20AR |
|
HIC |
Agilent/1260, 1290
Waters/E2695, Arc Bio
Thermo/Ultimate 3000
Shimatzu/LC-20AR |
|
PS-20/80 or other surfactant |
Agilent/1260, 1290
Waters/E2695, Arc Bio
Thermo/Ultimate 3000
Shimatzu/LC-20AR |
|
Histidine or other amino acids |
Agilent/1260, 1290
Waters/E2695, Arc Bio
Thermo/Ultimate 3000
Shimatzu/LC-20AR |
Capillary Electrophoresis |
|
SDS Reduced |
PA800 Plus |
|
SDS non-reduced |
PA800 Plus |
|
iCIEF |
ProteinSimple/iCE3
ProteinSimple/Maurice C |
Container Closure Integrity Testing (CCIT) |
|
Vacuum Decay |
PTI455 |
Compendial / Identity |
|
pH |
All instruments compliant to EP, USP, ChP |
|
Appearance |
All instruments compliant to EP, USP, ChP |
|
Endotoxin |
All instruments compliant to EP, USP, ChP |
|
Clarity |
All instruments compliant to EP, USP, ChP |
|
Degree of Opalesence |
All instruments compliant to EP, USP, ChP |
|
Color |
All instruments compliant to EP, USP, ChP |
|
Insoluble Particulate Matter |
All instruments compliant to EP, USP, ChP |
|
Recoverable/Extractable Volume |
All instruments compliant to EP, USP, ChP |
|
Filled Volume |
All instruments compliant to EP, USP, ChP |
|
Sterility |
4-gloves Isoflex |
|
Bioburden |
Milliflex plus pump |
BioPhysical / Spectroscopy |
|
Particulate Matter |
All instruments compliant to EP, USP, ChP |
|
Osmolality |
All instruments compliant to EP, USP, ChP |
|
UV280 |
Agilent/Cary100; C Technologies/SoloVPE |
Surface Plasmon Resonance |
|
Antigen Binding Affinity |
Biacore T200; 8K |
|
FcRn Binding Affinity |
Biacore T200; 8K |
ELISA |
|
Host Cell Protein |
Hamilton/Microlab Star; Biotek/ELX50; Biotek/405LS; MD/M5e; Bio-Rad/Chemidoc MP |
|
Residual Protein A |
Hamilton/Microlab Star; Biotek/ELX50; Biotek/405LS; MD/M5e; Bio-Rad/Chemidoc MP |
|
Potency |
MD/M5e; PE/Envision; Biotek/ELX405VRS |
BioChemistry |
|
Residual DNA by qPCR |
Applied Biosystem 7500 & Q7 |
|
Western Blot |
Invitrogen/PowerEase 500 Power Supply EI 8700; Bio-Rad/PowerPac Basic |
|
Karl Fisher Moisture Analysis |
Mettler Toledo/C30S |