Waker Bioscience Co., Ltd. specializes in gene therapy safety evaluations, particularly focusing on insertion mutation risk assessments. The company has developed a comprehensive integration site analysis (ISA) technology that adheres to domestic regulatory requirements, positioning itself as a leader in the field. Their services include high-precision CRISPR/Cas9 off-target analysis, vector copy number detection, vector quality control, and efficient sgRNA screening. Waker Bioscience employs advanced methodologies such as LTA-PCR and TES, which are recognized as validated ISA detection methods, to ensure the safety and efficacy of gene therapy products.

The company has established a genomics and bioinformatics analysis platform, supported by a state-of-the-art clean laboratory. Their ISA technology is crucial for assessing the biosafety of gene therapy vectors, which can potentially cause insertional mutagenesis when integrated into the host genome. By combining optimized PCR and sequencing techniques with proprietary bioinformatics systems, Waker Bioscience offers unparalleled precision in identifying integration sites and their frequencies. This innovative approach not only meets regulatory guidelines from organizations like the FDA and EMA but also enhances the safety profile of gene therapies, thereby contributing to the advancement of the field.

China

Room 402A, Building 6, No. 10, Oasis Ring Road, Pujiang Town, Minhang District, Shanghai, China

Waker Bioscience Co., Ltd.

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