Pharmacokinetics (PK) Services

Biocytogen provides high-quality PK services that include:

  • 1) Dose range finding
  • 2) Drug administration by any route (iv, ip, sc, po, it, im)
  • 3) Sample collections over specified time points from blood/plasma/serum and any other tissues
  • 4) Blood and tissue-specific PK analysis for biotherapeutics where detection antibodies are available
  • 5) Biodistribution including tissue collection and drug concentration determination of biotherapeutics where detection antibodies are available

PK Analysis of Anti-human CTLA-4 Antibody

PK workflow

PK-Workflow

PK analysis of an anti-human CTLA4 antibody in MC38-bearing B-hCTLA4 mice, where the extracellular domain of human CD40 replaces that of mouse CD40 via genomic knock-in. Anti-human CTLA4 antibody was administered i.v. at 0.1, 0.3, 1, 3 mg/kg. Plasma antibody concentrations were determined by ELISA (A) and PK parameters were derived by the non-compartmental model with Phoenix Winnolin 8.0. AUC0-∞ showed dose linearity (B) while half time (T1/2) was unchanged across the doses administered.

Group T1/2 (h) Cmax (ng/mL) AUC0-576h (h*ng/mL) AUC0-∞ Vd (mL/kg) Cl (mL/h/kg)
G1(CTLA4 mAb 0.1 mg/kg) 73 469 33563 39581 260 3
G1(CTLA4 mAb 0.3 mg/kg) 60 587 72898 83861 313 4
G1(CTLA4 mAb 1.0 mg/kg) 43 15717 774191 835554 76 1
G1(CTLA4 mAb 3.0  mg/kg) 95 61189 3330696 4513387 103 1

 

PK analysis results of anti-human CTLA4 in MC38-bearing B-hCTLA4 mice. Data was fitted by the non-compartmental model with Phoenix Winnolin 8.0.

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