CMC Relative Potency Analytical Methods: A Technical Deep Dive Course Outline

Who Should Attend: This is a recommended annual training course structured as continuation of Potency Bioassay Development & Validation Training course by Dr. Laureen Little. This course is meticulously designed to provide comprehensive education to lab personnel and managers of biopharmaceutical companies and CRO/CTL’s on the intricate technical aspects of relative format assays such as immunoassays, enzymatic assays, and bioassays. The curriculum is structured to ensure participants gain a deep understanding of the key areas covered in each session.

Click on the titles below to learn more about each session. Sign up anytime and receive links to recordings of any individual sessions or all five sessions. Although designed to be taken in a series, you may pick and choose individual sessions, as they are designed to be stand-alone units. When you are ready, click on the “Register Now” button to sign up for individual sessions or the full course. Each live session is interactive: Login, listen, learn and ask questions!

Platform Selection: Biological and Analytical Aspects

  • Instructor: Dr. Anton Stetsenko
  • Format: Live session in Early 2025. Recording available within two weeks after live session.
  • Content:
    • Animal vs cell-based assays
    • Expression & binding vs downstream signaling & effect
    • Multi-mode Mechanism of Action challenges
    • Stability indicating properties

Dose-Response and Dilutions Preparation

  • Instructor: Dr. Anton Stetsenko
  • Format: Live session in Early 2025. Recording available within two weeks after live session.
  • Content:
    • Dynamic range – cause and effect
    • Full and partial dose-dependent response
    • Arithmetic vs serial dilutions
    • Pseudo- and true replicates
    • Volume transfers and effect of errors
    • Impact on accuracy and precision of reportable value

Data Analysis, Part 1

  • Instructor: Dr. Anton Stetsenko
  • Format: Live session in Early 2025. Recording available within two weeks after live session.
  • Content:
    • Signal (plate) uniformity
    • Dilutional statistical unit
    • Model selection (linear and non-linear)
    • Transformation and weighting
    • Role of residuals
    • Model-based outliers’ analysis for dose-response model fit

Data Analysis, Part 2

  • Instructor: Dr. Anton Stetsenko
  • Format: Live session in Early 2025. Recording available within two weeks after live session.
  • Content:
    • Similarity (parallelism)
    • Assay and test sample acceptance criteria
    • Role of Assay Control
    • Tracking and trending

Software Review

  • Instructor: Dr. Anton Stetsenko
  • Format: Live session in Early 2025. Recording available within two weeks after live session.
  • Content:
    • Early development (Excel, Prism, JMP, R, Python)
    • Review of the most common specialized packages (STATLIA, PLA, QuBas, SoftMax Pro, CombiStats)
    • Data integrity (21 CFR parts 210 and 211)
    • Electronic records (21 CFR part 11)

COPYRIGHT: U.S. Copyright Law protects the program you are about to attend from unauthorized duplication. Multiple participants are not authorized to share access provided to a single registrant.  For each individual who attends, a single dedicated seat license must be purchased, or a group rate must have been previously arranged with FasTrain. FasTrain reserves the right, at its discretion, to cancel or interrupt access to a web-based training class without notice, or to invoice and collect the group rate payment for the class from the single registrant if this requirement has been violated.