Cell therapy weekly: improving T-cell isolation
This week: Thermo Fisher Scientific (MA, USA) expanded its CTS Detachable Dynabeads platform, the US Food and Drug Administration (MD, USA) granted Orphan Drug Designation to a gene therapy for Fabry disease and Cellino Biotech (MA, USA) appointed a new Senior Vice President of Therapeutics Development.
The news highlights:
- Improving T-cell isolation
- Fabry disease gene therapy gets Orphan Drug Designation
- Cellino Biotech appoints Senior Vice President of Therapeutics Development
Improving T-cell isolation
Thermo Fisher Scientific has expanded its CTS Detachable Dynabeads platform, launching the Gibco™ CTS™ Detachable Dynabeads™ CD4 and CTS Detachable Dynabeads™ CD8. These new products are designed to improve the isolation and activation of T cells with a focus on cell quality and workflow control.
CTS Detachable Dynabeads CD4 and CD8 allow efficient isolation of CD4+ and CD8+ T cells, minimizing cell stress while ensuring high purity and yield. This is particularly beneficial for CAR-T therapies, where a balanced mix of CD4+ and CD8+ cells is essential for effectiveness. When paired with the CTS Detachable Dynabeads Release Buffer, these products offer a unique cGMP cell selection technology with an active release mechanism, suitable for process development, clinical trials, and commercial production.
“As the number of CAR-T cell clinical trials grew by 125% from 2016 to 2022, biotech and biopharma companies are facing ongoing challenges across process development, clinical trials and commercial manufacturing,” said Sara Henneman, general manager of Thermo Fisher Scientific’s cell culture and cell therapy business. “The Dynabeads magnetic core is currently used in over 200 active clinical trials as well as several cell therapy drugs already approved for use. Our CTS Detachable Dynabeads CD4 and CTS Detachable Dynabeads CD8 represent the latest products from our platform that is accelerating innovation and increasing productivity for cell therapy manufacturers.”
Fabry disease gene therapy gets Orphan Drug Designation
The FDA has granted Orphan Drug Designation to Exegenesis Bio’s (PA, USA) novel gene therapy for Fabry disease, which results from a deficiency in the enzyme alpha-galactosidase A. This deficiency leads to a buildup of lipids in organs like the heart, kidneys and skin. Exegenesis Bio’s gene therapy, EXG110, introduces a functional copy of the gene encoding alpha-galactosidase A into cells, enabling them to produce the missing enzyme. This helps break down the lipid accumulation, alleviating the symptoms of Fabry disease and preventing further organ damage.
“The FDA’s decision to grant orphan drug designation to EXG110 highlights the need for better approaches to treat Fabry disease, a debilitating condition that affects thousands of people worldwide. We believe this is validation of our rigorous science, our innovation culture and our strong commitment to rare disease patients,” stated Zhenhua Wu, CEO of Exegenesis Bio.
Cellino Biotech appoints Senior Vice President of Therapeutics Development
Cellino Biotech, a company focused on developing advanced platforms that enable efficient, scalable production of cell-based therapies, particularly for regenerative medicine, has appointed Chris Gemmiti as Senior Vice President of Therapeutics Development.
Before joining Cellino, Gemmiti was Vice President of Technical Operations at CRISPR Therapeutics (Zug, Switzerland), where he led CMC efforts for CASGEVY, the first approved CRISPR-edited therapy for sickle cell anemia and beta-thalassemia.
“Chris has an impressive background as a scientist and biopharma leader, with a successful track record of developing novel therapeutics in the field of regenerative medicine,” said Nabiha Saklayen, CEO and co-founder of Cellino. “As we start to advance our pipeline and pursue high-value strategic partnerships, we believe his expertise will be invaluable to our team and we’re thrilled to welcome him.”
