Waker Biology

Waker Bioscience provides safety assessment services for cell and gene therapy drug products. The company specializes in insertion mutation risk assessment, quantitative off-target analysis for CRISPR/Cas9, and sgRNA screening. Their services cater to pharmaceutical clients, aiming to help them develop novel cell and gene therapies that meet regulatory safety standards. The service portfolio includes Integration Site Analysis, On-/Off-Target Analysis, Vector Copy Number, and Vector Quality Control.

Operating under GLP regulations, Waker Bioscience has an 800-square-meter laboratory and has established an advanced genomics and bioinformatics platform. The company's core technologies, S-EPTS/LM PCR and TES systems, originated from Manfred Schmidt's team at the German National Cancer Center. Waker Bioscience reports having participated in over 130 gene therapy projects globally and completed insertion mutation risk assessments for more than 50 clinical trials. They offer customized services that cover the entire process from sample receipt and quality control to library preparation, next-generation sequencing, bioinformatics analysis, and providing ISA risk assessment reports.

Keywords: gene therapy, cell therapy, biosafety assessment, insertion site analysis, off-target analysis, vector copy number, CRISPR, Cas9, sgRNA screening, drug development, regulatory compliance, next-generation sequencing, bioinformatics, genomics, pharmaceutical services, drug safety