Issue 206
Sterility testing is difficult for autologous cell and gene therapies because of limited volumes and the need for speed. Are more rapid testing methods needed? According to a group of researchers at SCTBio, the answer is yes.
The compendial sterility test represents the current industry standard approach – yes, it’s reliable, but it also takes days to complete. The SCTBio team decided to develop and qualify a more rapid sterility test; notably, they demonstrated that their test effectively detected bacteria or fungi inoculated at 10 CFU, while the compendial sterility test did not always yield positive results at this concentration. Meanwhile, the test’s ability to accurately detect negative samples confirmed its specificity.
Of course, this is but one area of CAR-T optimization – can you think of any other neglected areas? Drop me a line: [email protected].
Until next week,
Jamie Irvine | Associate Editor
Essential Reading
AstraZeneca’s latest move
AstraZeneca is investing $300 million in a new facility – based in Rockville, Maryland – to launch cell therapy platforms in the US for “critical cancer trials and future commercial supply.” The investment will initially focus on manufacturing T-cell therapies for global clinical trials, with potential expansion to support other diseases. “We are incredibly excited that more than 150 new highly skilled jobs are being created to bring our scientific work and therapies to clinical trials which could transform the lives of patients around the world,” said Pam Cheng, Executive Vice President of Global Operations & IT and Chief Sustainability Officer at AstraZeneca in a press release. “This new $300 million investment will accelerate our ambition to make next-generation cell therapy a reality, ensuring that we are ready to scale and meet the demands of patients.”
Targeting tumors
The scarcity of “good” targets represents a major limitation to the success of CAR-T cell therapies against solid tumors. Despite years of research, only a handful of potential targets have been identified from monoclonal antibody therapy studies. Researchers from the University of Los Angeles have now developed a CAR-T therapy that detects surface tyrosinase related protein 1 (TYRP1) in tumor cells with high TYRP1 overexpression and presents antitumor activity in vitro and in vivo in murine and patient-derived cutaneous, acral, and uveal melanoma models. Importantly, they found no systemic or off-tumor severe toxicities are observed in an immunocompetent murine model.
Worth Your Time...
Research
Researchers develop AAV-mediated gene therapy for neuraminidase 1 knockout mouse model of sialidosis – a metabolic disorder characterized by deficiency of the enzyme neuraminidase.
Bespoke Gene Therapy Consortium establish public–private partnership to address biological, manufacturing, and regulatory challenges of gene therapies.
Scientists use interleukin-24 to eliminate cancer stem cells and enhance CAR-T cells with improved antitumor reactivity.
Business
BioNTech and Autolus announce collaboration to advance CAR-T programs towards commercialization and expand late-stage programs (pending regulatory authorizations).
EMA releases a progress update on pilot for academic and non-profit developers of advanced therapy medicinal products and describes current participants.
Flash Therapeutics and CEA extend decade-long collaboration for development of cell therapies against skin conditions.
