Rentschler Biopharma Offers New Toolbox for LV Manufacturing

Editor's note: this story was originally published on BioPharmInternational.com.

Rentschler Biopharma, a biopharmaceutical contract development and manufacturing organization (CDMO), announced on Sept. 3, 2024, that it has launched an expanded service offering at Stevenage, UK, the company's advanced therapies site. With the expanded offering, Rentschler Biopharma now offers a new lentiviral vector (LVV) manufacturing toolbox for producing advanced therapy medicinal products (ATMPs), which complements the company’s existing adeno-associated virus (AAV) viral vector services.

The Stevenage site offers customized solutions for accelerating viral vector programs and includes novel, license-free toolboxes for AAVs and LVVs, according to a company press release. The company’s proprietary human embryo kidney 293 (HEK293) cell line offers additional time and cost savings for advanced therapy projects. The company’s services contributed to nearly 25% of FDA-approved biopharmaceuticals in 2023, Rentschler Biopharma stated in the press release.

“We made a strategic investment in the cell and gene therapy sector, starting with adeno-associated viral vector services, so we could offer our development and manufacturing expertise and sector experience to support innovators in this fast-developing space,” said Christiane Bardroff, chief operating officer, Rentschler Biopharma, in the press release. “We are now pleased to build on our success and augment this offering with lentiviral vectors. Our company remains dedicated to evolving our portfolio to enhance the health and quality of life for seriously ill patients around the world.”

Growing research and positive clinical results across a range of therapeutic applications has increasingly brought LVVs to the forefront in the advanced therapy space. Using LVVs for gene transfer has been applied to treat several genetic diseases, including beta-thalassemia. LVVs have also been used introduce genes to T-cells to modify them and generate immunity against cancer (1).

“The new lentiviral vector manufacturing toolbox highlights our commitment to providing cutting-edge solutions that enable our clients to advance their viral vector programs from pre-clinical and clinical development to market. By integrating lentiviral vector process development and manufacturing to our services, we are better serving the market by meeting the growing needs of the evolving and vibrant global advanced therapies sector,” said Robert Panting, general manager, ATMP, Rentschler Biopharma, in the press release.

Manufacturing LVVs has traditionally been difficult because they are enveloped viruses, which are more delicate and sensitive than non-enveloped viruses. LVVs are therefore more sensitive to temperature, pH, shear, etc. (2).

Because of their sensitivity, purification approaches for LVVs are typically gentler, often applying one single-step chromatography and one concentration/buffer exchange step; however, final sterile filtration is still a challenge and may impact titer and yield. Designing a manufacturing process must therefore consider how to mitigate yield loss all along the way (2).

References

1. Ghosh, S.; Brown, A. M.; Jenkins, C.; Campbell, K. Viral Vector Systems for Gene Therapy: A Comprehensive Literature Review of Progress and Biosafety Challenges. Applied Biosafety 2020, 25 (1), 7–18.
2. Mirasol, F. Comparing Viral Vectors for Gene Therapy Delivery. BioPharm International 2024, 37 (7) 10–13.

Source: Rentschler Biopharma