Maximizing recovery in lentiviral downstream processing: strategies from development to GMP

Ishtiaque Rashid is a Downstream Process Development Scientist at Genezen, where he develops and optimizes downstream manufacturing processes for pseudotyped enveloped viral vectors, including lentiviral vectors (LVV), retroviral vectors (RVV), and VSV-G–pseudotyped vectors. He began his career in academia as a faculty member before transitioning to the biotechnology industry, gaining extensive experience across viral vectors, monoclonal antibodies, and plasmid DNA.

Prior to joining Genezen, Ishtiaque served as a Lead Scientist in Downstream Process Development at National Resilience and Thermo Fisher Scientific. His scientific background in DNA repair research and protein purification, combined with his expertise in process development for advanced biologics, has enabled him to contribute to the translation of innovative cell and gene therapies from development to manufacturing.

Nick Clarkson has over 20 years’ experience in research and development in cell and gene therapy and immunology and is currently Vice President and Head of Process Development at OXB which is a world leading viral vector CDMO.  He has held senior leadership roles in innovation and analytical development within OXB giving him a breadth of experience spanning basic research and development in viral vector manufacturing platforms, through to scale up for GMP manufacturing and validation for commercial products. He gained his D. Phil from Oxford University where he spent over 10 years at Oxford University’s Sir William Dunn school of Pathology studying T cell biology before transitioning to Industry. He spent 4 years at ProImmune, developing state of the art immunogenicity assays and testing services for the pharmaceutical industry before joining OXB.

René Gantier is Senior Director, R&D, Advanced Bioprocess Applications at Repligen, where he provides strategic and technical leadership in the development of advanced bioprocessing technologies and next-generation manufacturing solutions.

With more than 20 years of experience spanning bioprocess development, purification, and manufacturing innovation, he has built deep expertise across biologics, monoclonal antibodies, and cell and gene therapies.

In his current role, René leads initiatives focused on process intensification, smart manufacturing, and digitally enabled bioprocess control, with particular emphasis on process analytical technology, automation, and integrated data-driven workflows for advanced therapies.

Prior to joining Repligen, he led the Biotech Process R&D team at Pall Life Sciences, driving the development of end-to-end upstream and downstream continuous bioprocessing solutions and advancing the integration of real-time analytics, automation, and digitally enabled process intensification.

René holds an MSc in Cell Biology from the University of Nantes, France, and a PhD in Biochemistry from the University of Rouen, France.

Paul Carter is Senior Director of External Manufacturing Vector at Quell Therapeutics, responsible for developing and manufacturing viral vectors used to modify Treg cells. Before joining Quell, he spent 33 years at GSK, most recently as Head of Viral Vector Downstream Process Development within the Cell and Gene Therapy Unit. Earlier, he spent ten years in Upstream and Downstream Process Development on therapeutic proteins and monoclonal antibodies, and contributed to small molecule drug discovery, including reagents for high throughput screens and proteins for structural biology, delivering several world first protein structures.

Paul has led the development of GMP manufacturing processes, characterised through Design of Experiments methodologies. He has significant expertise in analysing biological molecules, including protein structure for crystallography, and in characterising viral vector functionality using assays such as flow cytometry and PCR to determine viral titre and infectivity, as well as assays for residuals and clinical biomarkers.