De-risking lentiviral vector production using a robust, scalable, suspension-based platform

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

Lentiviral vectors (LV) are a potent tool in the growing field of cell and gene therapy because they enable efficient delivery of genetic material into cells for therapies such as CAR-T and HSC-based gene therapies. With the increasing number of clinical applications and interest in the field, robust, scalable, and cost-effective platforms for GMP manufacturing of high-quality lentiviral vectors are urgently needed. 

Many companies looking to utilize lentiviral vectors have faced the common roadblocks and problems associated with traditional LV production of undesirable regulatory elements of plasmids, high costs, and long lead times for manufacturing slots.

In this webinar, we will describe ElevateBio BaseCamp’s LentiPeak™ LV production platform - a robust and well-established platform process for LV production based on transient transfection of serum-free cells grown in suspension, which is designed to address common industry problems.

The LentiPeak™ platform has displayed high upstream infectious titers (~1E8 TU/mL) and a low particle-to-infectious titer ratio (< 1000 particles/TU) across a variety of commonly utilized therapeutic transgenes, and has demonstrated robust scalability in both small-scale and large-scale bioreactors. The final purified product from LentiPeak™ shows efficient and potent transduction of primary cells and remarkable reduction in the host cell protein (HCP), host cell DNA, and plasmid DNA impurity content.

While aiming to generate a robust, scalable and GMP-compatible process, BaseCamp also focused on streamlining workflows to accelerate our partner’s timelines by immediate access to manufacturing slots and a seamless transition from PD to GMP manufacturing in the following aspects: ability to produce LVs coding for different genes of interest (GOI) including CAR/TCR constructs, employment of the single-use technologies, employment of non-animal-derived raw materials, and alignment of equipment, protocols, and data collection tools between PD labs and GMP manufacturing suites.

• A review of current industry-wide challenges faced by companies utilizing lentivirus as therapeutic modality
• Overview of the development of the LentiPeak™ platform: from upstream titer optimization to downstream impurity reduction and considerations for cGMP-compatible production
• A review of the benefits of utilizing a lentivirus production platform: time savings, scalability, accessibility to manufacturing slots

Jimmy Xin

Scientist, Vector Process Development, ElevateBio

Jimmy Xin is an accomplished scientist with extensive experience in the cell and gene therapy field. Currently, he works as a scientist in vector process development at ElevateBio, where he develops, scales, and transfer processes for the production and purification of viral vectors, with a focus on AAV and LVV vector development. He also played an instrumental role in the development of ElevateBio’s LentiPeak™ platform process for manufacturing of lentiviral vector material. Prior to his role at ElevateBio, Jimmy worked in the downstream process characterization group at bluebird bio, where he compiled and analyzed the data for bluebird bio’s first commercial product, Zynteglo™, as well as supported the development and tech transfer activities for additional commercial products: Abecma™ and Skysona™.

Jimmy has demonstrated expertise in the technical aspects of downstream purification, including depth, tangential flow, and nano-filtration, as well as other purification techniques like nuclease treatment, chromatography (Affinity, AEX, CEX, HIC), and final formulation. He is also knowledgeable in late-stage process development and characterization activities for developing a path forward to Process Performance Qualification (PPQ) and filing of commercial processes. He holds a B.S. in chemical engineering from the University of Florida, where he served as both a research assistant and undergraduate assistant in various biophysical laboratories.

Poornima Manavalan

Director, Business Development, BaseCamp, ElevateBio

Poornima Manavalan is a member of the Business Development team at ElevateBio BaseCamp, supporting the Cell and Gene Therapy manufacturing business. Poornima received her Bachelor of Technology (B.Tech) from Jawaharlal Nehru Technological University, in Hyderabad, India and her Master’s degree in Biological Sciences from the University of Massachusetts, Lowell. Following her graduate work, she spent 7+ years in various Research and process development roles, most notably, leading projects in the development of a gene editing platforms to create stable cellular models to study autism spectrum disorders (ASD) at the Center for Human Genetic Research (CHGR), MGH. Following her extensive research and technical background, she pursued a career in Business Development where she successfully managed and helped grow FUJIFILM Irvine Scientific’s cell culture media services business and FUJIFILM Diosynth’s CDMO business prior to joining ElevateBio.

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SPEAKERS

Jimmy Xin

Scientist, Vector Process Development, ElevateBio

Poornima Manavalan

Director, Business Development, BaseCamp, ElevateBio

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