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Sourcing Inquiry Logo IPS Therapeutique

IPS Therapeutique

Regions
North America
Countries
Size
Specialty
Biopharmaceuticals
Service category
Clinical development and testing, clinical CRO
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Key services

Services

 

Safety Services

Safe Lead SelectTM

Automated hERGSCREEN

Functional hERG/Kv11.1 Potassium Channel inhibition assay using the Patch Express 7000 automated patch clamp system Protocol outline:

  • TA tested in 3 cells at 3 concentrations on HEK 293 cell stably transfected with the hERG gene.
  • Cisapride as positive control, IC50 determination

Manual hERGSCREEN
Rapid delayed rectifying potassium (IKr) current inhibition assay using manual whole-cell patch clamp technique. Protocol outline:

  • TA tested in 3 cells at 3 concentrations on CHO or HEK 293 cells stably transfected with the hERG gene.
  • Cisapride, dofetilide or E-4031 as positive control

APDSCREEN
Action Potential Duration analysis in purkinje fibres or contractile cardiac tissue. Protocol outline:

  • TA tested in 3 tissues at 3 concentrations
  • E-4031 as positive control
  • Amplitude of the action potential, rate of depolarisation, APD30, 60, 90 determine

In-Vivo/In-Vitro QTSCREEN
Study package including manual hERGscreen & in-vivo ECG in small animal. Protocol outline:

  • hERG: TA tested in 3 cells at 3 concentrations on HEK 293 cell stably transfected with the hERG gene.
  • In-vivo ECG and arterial blood pressure in conscious and surgically instrumented animals, with suitable DSI telemetry monitoring
  • Cisapride, dofetilide or E-4031 as positive control

E-C couplingSCREEN
Simultaneous APD and contraction measurements. Protocol outline:

  • TA tested in 3 tissues at 3 concentrations
  • Cisapride, dofetilide or E-4031 as positive control

IND-EnablerTM – For a prompt and seamless IND approval

The line of services entitled IND Enabler refers to the full-size, GLP-compliant cardiac toxicity assessment assays mentioned in the ICH guidelines S7A and S7B. Included in IND Enabler are the hERG inhibition assay, considered to be a necessary complement to the in-vivo assessment of QT prolongation in telemetered animals, as well as action potential duration measurements and analysis, and ionic current inhibition assays, both of which are labeled as complementary assays in the ICH guidance documents. The IND enabler assays are designed to generate reliable and unambiguous results which will confirm the absence of cardiac liability for a given compound, or alternatively, provide a clear indication of those conditions under which the compound may exhibit cardiac toxicity. In addition, it is considered an invaluable tool for assembling a convincing cardiovascular profile for your IND application.

hERGGLP
Full-size rapid delayed rectifying potassium (IKr) current inhibition assay using manual whole-cell patch clamp technique

  • TA tested on seven (7) HEK 293 cells stably transfected with the hERG gene at four (4) rising concentrations.
  • E-4031 as positive control, IC50 determination

APDGLP
Full-size Action Potential Duration analysis on purkinje fibres or contractile cardiac tissues from small animals, large animals and human donor hearts

  • TA tested on five (5) tissues and at 4 rising concentrations
  • E-4031 as positive control
  • Amplitude of the action potential, rate of depolarisation, APD30, 60, 90 determination

In-Vivo/In-Vitro QTGLP
Full-size pre-IND study package including manual hERGGLP & in-vivo ECG in small animal

  • Manual hERGGLP:
  • In-vivo ECG and arterial blood pressure in conscious and surgically instrumented animals, with suitable DSI telemetry monitoring
  • Cisapride, dofetilide or E-4031 as positive control

E-C couplingGLP
Simultaneous APD and contraction measurements on contractile cardiac tissues from small animals, large animals and human donor hearts

  • TA tested in 3 tissues at 3 concentrations
  • Cisapride, dofetilide or E-4031 as positive control

Torsades PredictTM – The most powerful assay to investigate arrhythmia issues

Torsades Predict is a line of premium services which goes beyond the quantification of cardiac risk. The assays included in Torsades Predict are aimed at identifying mechanisms of toxicity or at confirming the involvement of complex phenomena in the generation of arrhythmia. Parameters such as geometrical dispersion of repolarization or excitation contraction coupling, are thoroughly and extensively studied through unique and fully customized studies.

The Torsades Predict line of services uses innovative instrumentation, fully validated systems and processes, in order to achieve temporal and geometric resolution beyond those required by normal, pre-IND studies. It is understood that the assays performed within this line of product will generate parameters which may be unfamiliar; IPST is obviously dedicated to the design of the studies, its execution to the exacting standards expected from our company, as well as a complete analysis and interpretation of the results generated, in order to provide our sponsors with complex, yet clear conclusions.

  • Transmural dispersion of repolarization (TDR)
  • E-C Coupling

Human Cardiac Efficacy models

A unique tool to support or validate your cardiac efficacy data: IPST’s exclusive use of healthy human cardiovascular tissues in a validated, fully compliant context, has provided the pharmaceutical industry with a unique tool for verifying efficacy in functional human tissues devoid of pathologies.

Molecules targeting cardiovascular indications can be tested for efficacy in human tissues very early in preclinical development, through a series of electrophysiological or contraction relaxation measurements. The scientific and financial advantages associated with the in-vitro use of human tissues are evident: absence of species-specific differences, direct measurement of functional interactions with the intended targets, unequivocal demonstration of efficacy for compounds in early drug development.

In assembling a range of validated assays using human tissues in an in-vitro context, IPST has thought of both scientists and investors. As scientists, we are definitely interested in the fate of the molecules we test and develop, however, we also are well aware of the importance of satisfying investor concerns at various times during the drug development process. The human cardiac efficacy models have thus far established a splendid historical record as both predictors of cardiac toxicity, and models of efficacy for cardiovascular compounds.

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