Testing Services

Flocel Inc. provides in vitro BBB permeability testing on a contract basis. The fee structure is set by the number of compounds to be tested and the complexity of the testing. This service is performed in the laboratories at the Cleveland Clinic Foundation, at Stanford and in Europe. We also offer consulting services on brain biomarkers and testing in human subjects BBB integrity by analysis of peripheral blood.

Experiments:
  • Short-term Exclusion Assessment:
    1. To mimic acute permeability after IV injection. Plasma vs. brain levels are compared and "P" value is calculated. To compare these values with known permeant or non-permeant compounds, simultaneous injection of 14C Sucrose and/or 3H-Theophylline is usually employed.
    2. Results are comparable to published "P" values for a variety of compounds.
    3. Compounds are injected intraluminally, and concentrations detected intra- and extraluminally for 60 minutes at 5-10 minute intervals.
  • Acute determination of Active Exclusion:
    1. To evaluate if a low permeability detected as in Short-term Exclusion Assessment is due to
      1. Active extrusion
      2. Poor octanol-water partition
    2. Compounds (three observations per compound) are injected extraluminally, and concentrations detected intra and extraluminally for 60 minutes at 5-10 minutes intervals.
    3. If requested, the experiments may be repeated for the same fee in presence of putative extrusion (e.g., PgP) blockers.
  • Long-term determination of Active Exclusion:
    1. To evaluate if a low permeability detected as in Short-term Exclusion Assessment is due to
      1. Active extrusion
      2. Poor octanol-water partition
    2. The experimental design mimics an "IV drip" with plasma concentrations constant for 24-48 hrs.
    3. Compounds (three observations per compound) are injected intraluminally, and concentrations detected intra and extraluminally for up to two days at 1-2 hrs intervals.
    4. If requested, the experiments may be repeated for the same fee in presence of putative extrusion (e.g., PgP) blockers.
  • Chronic Exposure/Assessment of Long-term Toxicity and Pharmacokinetic Properties
    1. To study the effects of a given compound on BBB integrity
    2. Measurement of trans-endothelial electrical resistance or sucrose

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