Blog

Investigating Unforeseen Outcomes in a Culture of Quality

A willingness to investigate unwelcome results is integral to building and maintaining a culture of quality. My first two Quality Quarterly issues focused on bioassays and total analytical error. I chose these topics because the resolving…

Upcoming Publication: Practical Considerations in Using an Equivalence Approach to Establish Lot Release Limits for Vector Dose

BioProcessing Journal  has invited Dr. Janice Callahan and I to publish a second manuscript as a follow-on to a prior publication proposing an equivalence model for lot release and vector dose assignment. This preview of the work-in-progress…

Total Analytical Error (TAE) from Concept to Calculations

Do you struggle with understanding statistical concepts applicable to your role and responsibilities in the development of biologics? Are you aware of the trend toward Bayesian statistical inference and the shift away from the frequentist…
Nancy Sajjadi

Developments in Bioassays

For over 30 years, I have been involved in the quality control of experimental biologics and have witnessed both incredible outcomes and tragic disappointments in addressing many different unmet clinical needs. I recently attended a conference…

Co-chair panel Bioassays and statistics FAQs to FACTS

In this session, Nancy Sajjadi and Steve Walfish introduce 4 speakers and posit several questions to address hot topics in bioassay design, development and validation:  Generating and evaluating the standard curve, establishing equivalence…