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…

Working toward an adenoviral vector testing standard

This paper summarizes the proceedings of a conference held to discuss the development of an adenoviral vector standard.  In response to the tragic death of Jesse Gelsinger, dose related toxicity became a focus in the field of gene therapy.…

Generation of retroviral packaging and producer cell lines for large-scale vector production and clinical application: improved safety and high titer

This paper, cited 70 times, describes improvements in retroviral vector packaging and producer cell lines designed to yield higher unprocessed manufacturing titers, complement-resistant vectors, and minimize the potential to  generate  replication-competent …

Development of retroviral‐based gene therapy products: a quality control perspective

This early article provided a broad overview and a brief history of quality control considerations in the development of retroviral-based gene therapy products.  As part of pioneering efforts in the field and early regulatory experience, I…

Evaluation of PCR and ELISA assays for screening clinical trial subjects for replication-competent retrovirus

This paper is cited as reference #30 in the FDA’s 2020 guidance on Testing of Retroviral Vector-Based Human Gene Therapy Products for Replication Competent Retrovirus During Product Manufacture and Patient Follow-up https://www.fda.gov/media/113790/download …