Achieving high yield and purity in lentiviral production using dPCR and IEX membranes

Wednesday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST

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Achieving high yield and purity in lentiviral production using dPCR and IEX membranes

Live30 webinars are thirty-minute presentations designed to update you on the latest innovations, applications, and data in a fast yet interactive format.

Streamline lentiviral vectors (LV) production with practical strategies to improve yield, purity, and regulatory confidence. This webinar showcases how a dual-method approach using digital PCR (dPCR) and p24 antigen ELISA enables high-sensitivity detection of replication-competent lentiviruses (RCL) to meet regulatory expectations.

In addition, learn how LV genomic RNA and vector copy number (VCN) can enhance quality control and provide direct insights into vector integrity in transduced cells, across production lots. The speaker will provide insights into how integrating a scalable ion exchange (IEX) membrane adsorber can cut processing time while more than doubling infectious unit recovery. Further, they will discuss actionable methods for improving analytics and scalability, all within a cGMP-aligned platform designed to support both clinical and commercial LV manufacturing.

Attend this webinar to:

Gain practical insights into how regulatory expectations for RCL testing are met with a dual-method approach, and key cGMP considerations
Learn from SK pharmteco experts about PCR-based testing, and applying them across production settings
Discover process parameters and lessons from optimizing IEX purification, enabling a two-fold recovery gain and greater downstream scalability

Jae Hwang

Senior Scientist, Downstream Process Development at SK pharmteco

Jae Hwang is a Senior Scientist in Process Development with over 9 years of expertise in biopharmaceuticals, focusing primarily on the purification and optimization of various modalities including monoclonal (mABs) and polyclonal antibodies (pABs), protein nanoparticles, exosomes, and viral vectors such as Lentiviral Vector (LV), Adenovirus (AdV), and AAV. At SK pharmteco, Jae innovated a novel LV Downstream Process Platform, improving recovery over two-fold and surpassing client expectations. Jae also developed a novel capture strategy that resulted in 50-110% infectious titer step yield, exceeding industry benchmarks. He optimizes diverse downstream processes, including AEX, TFF, and sterile filtration. Jae has experience in both process development (PD) and manufacturing (MFG) scales, including work in CGMP Grade B and A level suites. He has successfully enhanced downstream yields and performance for both internal and client projects. Jae graduated from Temple University (BS Biochemistry) in 2015.

Oxana M Tsygankova

Senior Scientist, Virology/Analytical Development at SK pharmteco

Oxana is a Senior Scientist with 2.5 years of experience in GMP testing for gene and cell therapy within the Virology Department at SK pharmteco. During her tenure, she has played a key role in developing cell-based methods and successfully established GMP-compliant assays for detecting replication-competent viruses in viral vector drug products. Her work has been recognized through presentations at ASCGT conferences and published in three papers. Currently, Oxana is part of the Department of Analytical Development, where she contributes to new assay development, assay transfers and qualification activities across both departments. She brings extensive research experience from her previous roles as a postdoctoral fellow and staff scientist at leading institutions such as Duke University and the University of Pennsylvania. Oxana earned her PhD from the Russian Academy of Sciences in Moscow.

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