Prediction of Infusion (CARPA) Reactions

CARPA Assay

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)
  • Electrocardiogaphy (ECG)
  • Expiratory/end-tidal Carbon Dioxide pressure (pCO2)
  • All Blood Cell Counts
  • White Blood Cell (WBC) differential
  • Coagulation Parameters
  • Skin reactions (rash, flushing)

 

Immunogenicity Assays

In vivo immunogenicity studies in the following model animals:

  • pig
  • dog
  • rat
  • mouse

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

 

Formulation of Complex Drugs

  • Formulation of Drug Carriers
  • Formulation of Vaccines

 

Complement Activation Assays

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)
  • SRBC (CH50) hemolytic assay, all species