Relative Potency: What is it and How is it Calculated

• Instructor: Dr. Laureen Little
• Format: On-demand recording of most recent live session will be available May 2024
  On-Demand Recording of previous live session available now!
• Content: The relative potency calculation is often based upon a ratio of the ED₅₀ of the test article to the reference material. However, there is a step-wise approach which goes into preparing the data set for this calculation. This session covers the basic calculation, the data requirements and provides a discussion of confidence intervals and how they are used in today’s potency world.

The Ins and Outs of Getting Your Dose-Response Curve Right: Dose Selection, Model-Fits

• Instructor: Dr. Laureen Little
• Format: On-demand recording of most recent live session will be available May 2024
  On-Demand Recording of previous live session available now!
• Content: The potency assay is essentially based upon a comparison of the dose-response curve of reference material to the dose-response curve of the test article. Therefore, it is important that an appropriate model be selected to represent the data obtained from the laboratory. This selection includes selecting the right model (4-parameter vs. straight line), number of doses on the curve and the concentration of each dose.

Similarity Testing: Equivalency vs. Difference Testing – A Practical Take on Implementation

• Instructor: Dr. Laureen Little
• Format: On-demand recording of most recent live session will be available May 2024
  On-Demand Recording of previous live session available now!
• Content: Before a potency calculation can be done, it is critical to determine if the reference and test article are sufficiently similar that the potency of the test sample can be estimated by comparing it to the reference material. Currently, the USP and the EP discuss two different approaches. This session will review both approaches, explain the underlying statistical rationale and provide a real-world approach for using these approaches during development and for commercial product release.

Rare Reagents: Discovery, Development, Qualification and Establishing QC Material

• Instructor: Dr. Laureen Little
• Format: On-demand recording of most recent live session will be available May 2024
  On-Demand Recording of previous live session available now!
• Content: A potency assay is only as good as its underlying analytical reagents. This is a practical overview of assay cell banks, viral banks, selection of animals for animal assays and a no-nonsense review of how to characterize and select appropriate reagents.

The Use of QbD Tools for Development – DOE Basics and Available Software

• Instructor: Dr. Laureen Little
• Format: On-demand recording of most recent live session will be available May 2024
  On-Demand Recording of previous live session available now!
• Content: Quality-by-Design applies to the development of analytical methods as well as manufacturing processes. Nowhere is this more apparent than in the bioassay field. This session provides a basic overview of DOE, what it is, what software is available and why it works for bioassays. This session has homework – so be prepared!

The Use of Outlier Approaches in Bioassays

• Instructor: Dr. Laureen Little
• Format: On-demand recording of most recent live session will be available May 2024
  On-Demand Recording of previous live session available now!
• Content: All too often potency calculations are thrown off by a single dilution or even a single point. When raw data is examined, it appears that a single “outlier” throws off the entire data set.  This session discusses these problems and talks about approaches, both statistical and practical, on how to protect your assay against these “flyers”.

Bioassays and the USP Recommendations

• Instructor: Dr. Laureen Little
• Format: On-demand recording of most recent live session will be available May 2024
  On-Demand Recording of previous live session available now!
• Content: The USP has provided the bioassay community with a suite of chapters about how to develop, design and validate biological potency assays. This session provides an in-depth review of these chapters, highlights what are their recommendations and how this compares with the current European chapters. Additionally, we will review how industry scientists and regulators are reacting to these chapters.

Qualification and Validation: ICH vs. Quality by Design (QbD) Approaches

• • Instructor: Dr. Laureen Little

Format: On-demand recording of most recent live session will be available June 2024
On-Demand Recording of previous live session available now!

• Content: Content: Currently, the industry is in flux. The ICH guidelines on validation have been in force for more than ten years and have been well accepted. The ICH committee recently released a rewrite of these influential guidelines to include total error analysis, partial validation approaches and more. However, in the potency field scientists are implementing more QbD approaches to validation, as outlined in the USP chapter on bioassay validation. The field is now balancing the two different validation approaches and throwing in the wildcard of changes to the longstanding ICH validation guidance. This session lays out the ICH validation, the new aspects of the recent rewrite and compares it to a more QbD approach and demonstrates that a best practice validation combines elements of QbD and ICH approaches.

Monitoring the Bioassay: What to Watch and How to Watch it

• Instructor: Dr. Laureen Little
• Format: Tuesday, 07 May 2024, 7AM PT / 4PM CET. Recording available within two weeks after live session.
• Content: Knowledge of statistical process control (SPC) and how to set appropriate system suitability criteria are the fundamentals of monitoring your bioassay. These will be reviewed, and bioassay case studies will be used to demonstrate the basic principles. Additionally, we will discuss what to monitor and warn against doing too much.

The Reference Standard: Characterization, Monitoring and Qualification

• Instructor: Dr. Laureen Little
• Format: Wednesday, 08 May 2024, 7AM PT / 4PM CET. Recording available within two weeks after live session.
• Content: The in-house reference material is the most crucial assay reagent you will need to develop. This entire session is devoted to this critical topic. We will start with establishing the first reference material, setting up a monitoring and stability program, cover how to do comparability testing to switch between references and end with a discussion about handling references in a commercial environment. There are several deadly reference traps which have taken commercial products off the market, these will be reviewed in great detail.

Recent Bioassay Inspection & Application Trends

• Instructor: Dr. Laureen Little
• Format: Thursday, 09 May 2024, 7AM PT / 4PM CET. Recording available within two weeks after live session.
• Content: The final session will review recent inspection and application results. This will highlight problems and common errors companies run into during licensure and post-approval. 483s from recent inspections will be discussed.