Serum-free, Suspension-based Lentiviral Vector Platform May Allow for Accelerated Production

ElevateBio BaseCamp has unveiled its new LentiPeak Lentiviral Vector platform, a serum-free, suspension-based, scalable production platform intended to produce vector yields for cell and gene therapy products according to regulatory standards with high volumetric productivity.¹

The platform is capable of producing lentiviral vectors for preclinical, clinical, and commercial scales with high titers ranging from 1x10⁸ TU/ml to 1x10⁹ TU/ml via its serum-free suspension process. ElevateBio plans to integrate the platform into its current end-to-end services, facilitating alignment in "unit operations, materials, analytics, and manufacturing expertise" for product development lifecycles. The company expects this will improve comparability in product quality from phase 1 to phase 3 clinical trials. ElevateBio also expects that the new platform will lessen costs and shorten timelines.

“Our team of industry-leading experts have developed next-generation platform-based processes that are designed to address lentivirus manufacturing challenges head-on,” Andrew Sandford, president, ElevateBio BaseCamp, said in a statement regarding the news.¹ “With our partners’ needs in mind, our proprietary LentiPeak platform has demonstrated leading vector titers with high potency, and process scalability to help our partners de-risk vector production, right from the start. At ElevateBio BaseCamp, we are ever committed to simplifying the complex cell and gene therapy landscape to enable our partners to rapidly progress their therapeutic programs and make these therapies more accessible to patients in need.”

The announcement is just one of many developments currently ongoing in the cell and gene therapy manufacturing space. Late last month, investigators at University Hospitals (UH) Seidman Cancer Center, working in collaboration with an unnamed biotech start-up company, announced development of a new manufacturing process for chimeric antigen receptor T-cell (CAR-T) therapies.² The process showed potential to reduce production times to approximately 24 hours, substantially down from the current commercial standard of about 3 weeks. The cells produced by this method were also shown to be more potent when tested in animal models. A first-in-human clinical trial for cells produced by this method is ongoing. 

Several other companies have also announced intentions to address challenges in cell therapy manufacturing. In a recent interview with CGTLive, Evan Zynda, PhD, senior scientist, Thermo Fisher Scientific, spoke about the company’s approach to increasing patient access and reducing time-to-treatment for cell therapies. In another interview, Raphaël G. Ognar, chief executive officer and co-founder, NKILT Therapeutics, spoke with CGTLive about the company's approach to process development and strategic partnerships for streamlining cell therapy manufacturing.

“As a 30-year veteran of the cell and gene therapy industry, I’ve witnessed the immense advancement of lentiviral vector technology from its infancy to the current landscape with 6 FDA-approved lentiviral vector-derived cell and gene therapies,” Mitchell Finer, PhD, co-founder and president of Research and Development, ElevateBio, added to the company’s statement.¹ “The LentiPeak platform is made possible by ElevateBio’s strong scientific foundation, industry-leading expertise, and the investments we’ve made into viral vector production. Our pioneering work continues to be the basis for our continued innovation to drive many more therapies through development to commercialization for our partners.”

REFERENCES

1. ElevateBioBaseCamp unveils its Lentipeak lentiviral vector platform. News release. ElevateBio, LLC. November 3, 2022. https://www.elevate.bio/press-releases/elevatebio-basecamp-unveils-its-lentipeak-lentiviral-vector-platform 

2. University Hospitals Seidman Cancer cCenter researchers slash time needed to produce CAR T-cells. News release. University Hospitals Cleveland Medical Center. October 21, 2022. https://news.uhhospitals.org/news-releases/seidman-cancer-center/university-hospitals-seidman-cancer-center-researchers-slash-time-needed-to-produce-car-t-cells.htm