Monoclonal Antibodies
DMPK support for monoclonal antibody programs. PK in relevant species, target-mediated disposition, tissue distribution and immunogenicity assessment, delivered with the bioanalytical methods developed and qualified in the same group.
OVERVIEW
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
