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Monoclonal Antibodies
We offer PK analysis and PKPD modeling for monoclonal antibodies with either affinity-based ligand binding assays or LCMS/MS-based quantification.
High Quality In-Life and BA
Purpose: to evaluate PK property of mAb after IV infusion administration in cynomolgus monkeys (n=4/group)
Study Design:

Dose: 4, 6, or 7 mg/kg
Sampling: Serum collection for 9 time points till 25 post dosing
Results: Good differentiation of PK curve at 4, 6, 7 mg/kg dose level

PKPD in NHP – B Cell Depletion in Lymphoma
Animals were dosed at 10mg/kg IV bolus (N=2).
Blood samples were collected until day 42 post dosing
ELISA measurement for Rituxan concentration; FACS analysis for B cell counting

B cell depleted immediately after IV dosing and maintained at low level until 21 days when started to recover
LC-MS/MS Quantification of Humanized mAb
Can be used in:
Chimeric ab. BA
Humanized ab. BA
Human ab. BA

ELISA Quantification of Humanized mAb
Generic/EASYELISA®
Fast – no extensive method development required
Saving
Easy – no antigen required
Antigen Method

Generic Method




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