Pharmacokinetic/pharmacodynamic (PK/PD) correlations for peptide and protein-based drugs are frequently convoluted by their close interaction with endogenous substances and physiologic regulatory feedback mechanisms. Extensive use of pharmacokinetic and exposure/response concepts in all phases of drug development has in the past been identified as a crucial factor for the success of a scientifically driven, evidence-based, and thus accelerated drug development process. Accuracy, precision, and specificity remain paramount criteria for those interpreting assay results.
Vela has extensive expertise in implementing PK assays for various clinical phases and different drug products.

Antibody formation is a frequently observed phenomenon during chronic dosing with biotech drugs, especially if the drugs were derived from animal proteins. The presence of antibodies can obliterate the biological activity of a peptide or protein drug. Also, protein-antibody complexation may modify its pharmacokinetic profile.
Vela offers Surface Plasmon Resonance SPR) based methodology to monitor the generation of anti-drug antibodies and the subsequent characterization of such anti-drug antibodies regarding isotype and their neutralizing potential.