Bioanalysis of gene and cell therapeutic products in new biotechnology era
With the modern biotechnology revolution well under way, gene and cell therapy have emerged as promising therapeutic modalities. By transferring therapeutic DNA/RNA or administrating living cells to patients, gene and cell medicines provide unique and revolutionary ways to treat cancers, rare diseases, inherited diseases and many other diseases that conventional drugs are ineffective.
Gene therapy can be delivered by both virus and non-virus systems while cell therapy consists of immunomodulatory cell therapy and stem cell therapy. Beyond that, oncolytic viruses, DNA/RNA vaccines and oligonucleotide therapeutics also treat diseases in gene manipulation and are often taken as gene and cell therapeutics. To date dozens of gene and cell therapeutic products have been approved by the FDA and thousands more are in different stages of preclinical and clinical trials worldwide. The exploratory rising of gene and cell therapy clinical trials bring a heavy demand of bioanalysis.
What will you learn?
- Safety assessment and efficacy of the gene and cell therapy thorough pharmacokinetics, tissue distribution, vector shedding, gene expression, immunogenicity and pharmacodynamics characteristics.
- Bioanalytical evaluations are different for gene and cell therapy products, when compared to chemical and protein drugs. Gene and cell therapy products are comprised of diverse chemical components and structures including DNA/RNA molecules, virus particles or gene modified cells.
- Bioassays used in cell and gene therapy development. New biological techniques such as qPCR/ddPCR, flow cytometry, hybrid LBA, HPLC-FL, ELISPOT are utilized as well as conventional ligand binding assays and liquid chromatography−mass spectrometry (LC−MS) assays.
Who may this interest?
- Gene and cell therapy bioanalysts
- Pharmaceutical and biotech professionals
- Oncology and rare disease scientists
- Toxicologists and immunologists
Speaker
Jianbo Diao, PhD
Sr. Technical Director
Bioanalysis Business Unit, WuXi AppTec (Shanghai, China)
Jianbo Diao joined the department of bioanalysis (BAS) in 2019 at WuXi AppTec and Dr Diao is currently the leader of qPCR and FACS groups at WuXi AppTec bioanalytical services business unit. Dr Diao has many years of experience in the bioanalysis of biological therapeutic products and has published 10+ peer reviewed papers. Dr Diao obtained his bachelor’s degree in the Department of Biotechnology in Zhejiang University (Zhejiang, China) and a PhD in Life Sciences College at Peking University (Beijing, China). In 2004, Dr Diao did his postdoctoral training at the Department of Biology, Purdue University (IN, USA) followed by an Associate Professorship at Fudan University (Shanghai, China).
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