Synthego, a leading provider of genome engineering solutions, today announced the launch of its IND-enabling (INDe) gRNAs, a transformative product offering that revolutionizes the CRISPR-based cell and gene therapy preclinical pipeline. This innovative offering empowers researchers with high quality gRNAs designed specifically for GLP-regulated preclinical and IND-enabling studies, incorporating comprehensive IND-compliant materials and documentation in their design and production and facilitating a seamless transition from preclinical to clinical applications.
“IND-enabling gRNA is the culmination of years of learning at Synthego to understand how CRISPR is used in preclinical and clinical applications in order to provide end-to-end support for cell and gene therapy developers,” said Paul Dabrowski, CEO of Synthego.
On the journey through the regulated landscape of CRISPR-based therapeutic development, every step counts towards realizing groundbreaking ideas for life-changing therapies. The IND-enabling phase plays a pivotal role, involving rigorous safety, toxicity, and efficacy testing of the therapeutic candidate, along with initial interactions with health regulators. This phase culminates in the submission of the Investigational New Drug (IND) application, paving the way for clinical trials.
The introduction of INDe gRNAs enhances Synthego’s industry-leading coverage of the entire discovery-to-clinic continuum when combined with Synthego’s recently inaugurated cutting-edge GMP facility, bolstering its support for the rapidly expanding CRISPR clinical industry. This expansion ensures customer success throughout the entire therapeutic development process. Leveraging Synthego’s proprietary Halo™ platform, a holistic system encompassing hardware, automation, chemistry, and dynamic learning models, each gRNA product within Synthego’s continuum is precisely tailored to meet the unique requirements of researchers at each phase of therapeutic development.
For more information, please visit www.synthego.com/inde.
