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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…

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 …

Anti-vector immunoglobulin induced by retroviral vectors

This paper summarizes work to character vector immunogenicity. Studies showed that intramuscular (i.m.) administration of retroviral vector induces strong anti-vector Ig responses, in a dose-dependent fashion. Although such anti-vector Ig was…