{"id":326,"date":"2020-10-08T17:43:43","date_gmt":"2020-10-08T17:43:43","guid":{"rendered":"https:\/\/www.joinnbio.com\/?page_id=326"},"modified":"2021-05-25T17:40:24","modified_gmt":"2021-05-25T17:40:24","slug":"analytical-assay-development-qualification","status":"publish","type":"page","link":"https:\/\/www.joinnbio.com\/development-services\/analytical-assay-development-qualification\/","title":{"rendered":"Analytical Assay Development & Qualification"},"content":{"rendered":"\n
\n\n
<\/div>\n \"Analytics\n\n<\/div>\n\n\n
\n\n
\n

\n
fig. 1 \u2014<\/span><\/div>\n JOINN Biologics <\/span>\n <\/h3>\n\n

\n Analytics Development <\/h2>\n <\/div>\n\n<\/div>\n\n\n
\n

Analytics provides the information for the quality of the product itself, as well as the levels of impurities. By providing sensitive and accurate analytical data, analytics can help upstream development by performing spent media analysis, or downstream purification by analyzing protein products. <\/p>\n\n\n\n

<\/div>\n\n\n\n
Subject<\/th>Characteristics<\/th>JOINN’s Analytical Methods<\/th><\/tr><\/thead>
Spent Media<\/td>Expressions (titer)
Amino Acids
Vitamins<\/td>		HPLC, biosensor (Octet)
HPLC
HPLC<\/td><\/tr>
Proteins<\/td>Concentration
Integrity
Heterogeneity
Aggregation
Charge variants
Glycosylation
Thermostability
Binding activity
Viscosity
Turbidity<\/td>		UV spectrometer
CE-SDS, SDS-PAGE, MassSpec
MassSpec (intact, subunit, peptide mapping)
SEC-MALS, 96-well DLS, Non-reducing SDS Page
Capillary isoelectric focusing (cIEF), HPLC-IEX
Released glycan by HPLC, MassSpec for attached glycan
DSF
Octet, ELISA
Visometer
Vis spectrometer<\/td><\/tr>
Impurities<\/td>Endotoxin
HCP
Protein A
Residual DNA<\/td>		LAL
ELISA
ELISA
qPCR<\/td><\/tr><\/tbody><\/table><\/figure>\n<\/div><\/div>\n\n\n\n

To learn more, please fill out the form below.<\/h3>\n\n\n\n\n\n
<\/div>\n\n\n\n

Follow us on<\/p>\n\n\n\n