Blog

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…

Assessing parallelism prior to Determining Relative Potency

With nearly 50 citations, this paper summarizes the unanimous agreement of a USP committee, that the method for assessing parallelism that is currently presented in 〈111〉 and in the European Pharmacopeia's Chapter 5.3 is flawed and should…

Phase 1 trial of FVIII gene transfer for severe hemophilia A using a retroviral construct administered by peripheral intravenous infusion

This paper, cited over 200 times, summarizes a phase 1 dose escalation study, 13 subjects with hemophilia A received by peripheral intravenous infusion a retroviral vector carrying a B-domain–deleted human factor VIII (hFVIII) gene. This was…

Defining a Detailed Approach to Using the Adenovirus Reference Material (ARM)

This white paper encouraged advocates of the adenovirus standard to carefully examine its use in the field. It was originally presented at conference in 2003 but the article has recently been made open access (https://www.bioprocessingjournal.com/afp/J25-Sajjadi.pdf)…

Analysis of testes and semen from rabbits treated by intravenous injection with a retroviral vector encoding the human factor VIII gene: no evidence of germ line transduction

In this paper, we demonstrated that a PCR assay to detect vector was fit for its intended purpose.  In collaboration with Kim Boekelheide at Brown University, my group addressed a key regulatory concern for integrating vectors- potential for…