Training Seminars

Cambridge Healthtech Institute Training Seminars offer real-life case studies, problems encountered and solutions applied, along with extensive coverage of the academic theory and background. Each Training Seminar offers a mix of formal lecture and interactive discussions and activities to maximize the learning experience. These Training Seminars are led by experienced instructors who will focus on content applicable to your current research and provide important guidance for those new to their fields.

TS11B: Essentials in Bioassay Development and Validation

WEDNESDAY, September 2 - THURSDAY, september 3


8:40 am - 6:00 pm Seminar Sessions
12:30 - 1:30 Lunch Provided
6:00 - 7:15 Taste of New England Networking Reception in the Exhibit Hall with Poster Viewing


8:30 am - 12:30 pm Seminar Sessions

Exhibit Hall Refreshment Breaks also provided.


Thomas Little, PhD, President and CEO, Bioassay Sciences, Thomas A. Little Consulting


About this Training Seminar:

CHI’s Bioassay Training Seminar provides a comprehensive presentation of the most important aspect of CMC and drug development the measurement of biological activity or potency. Learn about best practices for bioassay design, determining doses and plate layout, replicate strategy, outlier detection and removal. The courses also covers how to determine validity criteria, reference selection and systems suitability. Case studies for a variety of cell therapy, gene therapy and other therapeutic proteins will be presented.

A full presentation on bioassay method validation, including, robustness, linearity, repeatability, intermediate precision, accuracy, range and specificity. Study design, method of analysis and acceptance criteria are all presented.

The Following Topics Will Be Covered:

  • Bioassay Design
  • Dose Ranging
  • 4PL fitting
  • PLA and dose masking
  • DOE for signal optimization
  • Replicate Strategy
  • Selection of Validity and Systems Suitability
  • Calculator Design
  • Outlier detection and removal, confidence intervals
  • Qualification and Validation of Bioassay
  • Study 1
    • Repeatability
    • Linearity
    • Accuracy
    • Range
  • Study 2
    • Specificity
  • Study 3
    • Intermediate Precision
  • Study 4
    • Robustness
  • Study 5
    • Stability indicating
  • Presentation covers sample size, method of quantitation, acceptance criteria
  • Bioassay Control

SAS/JMP will be used in all calculations during the course, Free download of the software for evaluation may be obtained from their website. Attendees should bring laptop computers

Instructor Biography:

Little_ThomasThomas Little, PhD, President and CEO, Bioassay Sciences, Thomas A. Little Consulting

Dr. Little is President of BioAssay Sciences (BAS) a globally recognized bioassay consulting company for biologicals and vaccines. BAS specializes in the design, calculation and control of potency and relative potency for bioassays. BAS specializes in In-Vivo and In-Vitro bioassays. BAS works with international companies and health authorities globally to achieve product development goals aligned to ICH and USP guidance. BAS is a strategic partner of SAS/JMP and a division of Thomas A. Little Consulting. Dr. Little has developed specific content courses in statistical methods and data analysis, Bioassay Design and Validation, Quality Risk Management, design of experiments, Robust Optimization, Design Space and Tolerance Design, Assay Development and Method Validation, statistical process control, mixture design of experiments, Stability Analysis and Nonlinear Modeling. These courses are used by a variety of fortune 100+ companies to train their chemists, engineers and scientists.


Each CHI Training Seminar offers 1.5 days of instruction, refreshment breaks, exhibit hall functions, and lunch for all registered attendees on the full day of the class. Each person registered for the Training Seminar will be provided with a hard copy handbook for the Training Seminar in which they are registered. A limited number of additional handbooks may be available for other delegates. CHI encourages track hopping between conference programs, and we ask that Training Seminars not be disturbed once they have begun. We ask that attendees commit to attending the entire 1.5-day training, and not engage in track hopping once the class has started.