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How Ultrasensitive Biomarker Detection Platforms Accelerate Drug Development Research

Drug development research involves a huge investment of time and resources. Learn how ultrasensitive biomarker detection platforms, such as the Single Molecule Counting (SMC®) technology platform, can enable the acceleration of drug development research programs.

Drug Development Research Pipeline

Drug development research programs span many years because drug candidates have to go through multiple stages before reaching the market. They also involve the evaluation of drugs through pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity testing. A typical timeline of this is shown in Figure 1.

A timeline of a typical drug development research program. PK/PD and immunogenicity testing are important from preclinical testing to Phase III, and immunogenicity testing and ongoing pharmacovigilance occur after approval.

Figure 1.A timeline of a typical drug development research program. PK/PD and immunogenicity testing are important from preclinical testing to Phase III, and immunogenicity testing and ongoing pharmacovigilance occur after approval.

As shown in Figure 1, the stages of drug discovery include discovery, preclinical testing, clinical development/Phase I, Phase II, Phase III, approval, and market. Examples of what is studied in each stage are:

Discovery

  • Target identification
  • Receptor binding
  • Occupancy
  • Time on target
  • Drug target

Preclinical Testing

  • Proof of mechanism
  • Species differences
  • PK/PD
  • Absorption, distribution, metabolism, excretion (ADME)
  • Safety/toxicology
  • Dose ranging
  • Drug delivery
  • Efficacy
  • Clinical validation

Clinical Development/Phase I – Phase III

  • Phase 0 micro-dosing
  • Phase I-III trials
  • Efficacy
  • Safety
  • Human PK
  • Dose selection
  • Bioavailability

Approval/Market

  • Phase IV
  • Safety
  • Efficacy
  • Diagnosis
  • Staging
  • Treatment planning and monitoring
  • Prognosis
  • Post-market surveillance
  • Ongoing pharmacovigilance

Testing for PK/PD and immunogenicity are critical in most stages for the thorough evaluation of drug candidates.

PK/PD Testing

PK/PD testing helps determine how the drug is working in the body. The differences between the two are described in Table 1 and Figure 2.

Table 1.Pharmacokinetics vs pharmacodynamics.
Understanding drug and effector response through pharmacokinetics and pharmacodynamics.

Figure 2.Understanding drug and effector response through pharmacokinetics and pharmacodynamics.

The ultimate goal in PK/PD testing is to deliver the right dose to the right patient. Learn more about how ultrasensitive detection platforms can provide complete PK/PD profiling.

Immunogenicity Testing

Immunogenicity testing measures the immune response to a dosed biotherapeutic. It involves the detection of anti-drug antibodies (ADA) and neutralizing antibodies (NAb). This helps determine if a drug will fail to get approved by giving an indication of efficacy, treatment outcomes, and any adverse effects such as hypersensitivity, infusion reactions, or anaphylaxis. By performing immunogenicity testing, researchers decrease the failure rate of drugs and save time and money.

Discover more about immunogenicity and how ultrasensitive detection platforms can assist in this type of testing.

Ultrasensitive Detection Platform for Drug Development Research

Ultrasensitive immunoassay detection technology enables the acceleration of drug development research programs. The Single Molecule Counting (SMC®) technology was designed to meet the needs of drug development research programs.

For example, features include:

  • High sensitivity platform
  • Rapid sample reading time
  • Simple design with no fluidics
  • Low maintenance
  • Automated System-wide Suite of Instrument Self Tests (ASSIST) requiring no user intervention
  • Automation compatible
  • Industry-leading dynamic range (4-5 logs)
  • Integrated data analysis software
  • Single data output for simple export to LIMS
  • 21 CFR Part 11 compliant software
  • IQ/OQ/PQ validation services
  • For Research Use Only. Not For Use In Diagnostic Procedures.

Watch the webinars below to see case studies of SMC® technology being used in drug development research.

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