In vivo analysis of test drug-induced hemodynamic, hematological, biochemical, immunological and skin alterations. The experiment may be conducted on juvenile domestic pigs (the most sensitive platform), dogs, rats and mice. During the experiment the following parameters are acquired and analyzed:
Pulmonary Arterial Pressure (PAP)
Systemic Arterial Pressure (SAP)
Cardiac Output (CO)
Heart rate (HR)
Expiratory/end-tidal Carbon Dioxide pressure (pCO2)
All Blood Cell Counts
White Blood Cell (WBC) differential
Skin reactions (rash, flushing)
In vivo immunogenicity studies in the following model animals:
In vitro assessment of anti-drug and anti-carrier antibodies, natural and induced.
Anti-drug IgM and IgG antibodies (ADAs)
Anti-phospholipid, anti-cholesterol antibodies
Anti-insulin and other antibodies against proteins/peptides
In vitro assessment of standard and immune response-related hematological descriptors.
WBC, RBC, platelet and lymphocyte counts and WBC differential
Plasma thromboxane, PAF, histamine, leukotrienes, tryptase
In vitro assessment of test drug-induced complement activation in serum/plasma/whole blood.
Assessment of human C3a, C5a, C4d, Bb, SC5b-9
Assessment of C3, all species (PAN-C3)
Assessment of iC3b opsonization and terminal complex (C5b-9) deposition
SRBC (CH50) hemolytic assay, all species
In vitro assessment of test drug-induced Basophil activation in serum/plasma/whole blood.
Formulation of Complex Drugs
Formulation of Drug Carriers
Formulation of Vaccines
Professional advice on
Optimization of particle surface composition and size in order to decrease infusion reaction (CARPA) liability
In vitro, in vivo and clinical study design and regulatory reporting for immune system-related toxicity