In an era of strong regulation, GentleGen' biopharmaceutical safety evaluation collaborates to build a "safety moat" for innovative drugs.

Release time:2026-06-26

The global regulatory environment for biomedicine is accelerating and tightening. From the "Drug Standard Management Measures" to the "Technical Guidelines for Post-Marketing Safety Evaluation of Drugs," and the ongoing revision of drug management regulations, regulatory authorities' requirements for biopharmaceutical safety have shifted from "post-market compliance" to "full-chain proactive quality control." For innovative drug companies committed to dual submissions in China and the US, safety verification is no longer a "fill-in-the-blank" in the application process, but a "must-answer question" determining whether an IND/BLA can be approved.

Traditional testing technology has encountered bottlenecks

Biologics, especially cell and gene therapy (CGT) drugs, possess a high degree of biological complexity. Regulatory authorities' control over product quality has evolved from "visible traits" to "invisible sequences." Strict confirmation of monoclonal origin, tracking the genetic stability of exogenous genes during passage, and precise localization of integration sites have become the "three major hurdles" that CGT drug development must overcome.

However, traditional testing methods are showing obvious limitations:

Finite dilution + microscopic examination: low resolution, prone to missed detection of low-proportion heteroclones;
Sanger sequencing and qPCR: can only detect known regions and cannot detect unknown mutations or gene rearrangements;
Southern blot and FISH: Integration site localization is inaccurate and cannot capture unknown insertion sites.

There's a consensus in the industry: "The real risk is the risk you can't detect." " As the throughput, sensitivity, and information dimensions of traditional methods approach their ceiling, biopharmaceutical safety evaluation urgently needs technological innovation.

GentleGen NGSafety™: Redefining safety assessment standards with NGS technology

Against this backdrop, GentleGen, a biotechnology solution provider focused on automation and intelligence, offers a one-stop NGSafety™ technology platform based on high-throughput sequencing. This platform covers sub-product lines such as mRNA-NGSafety™, CRISPR-NGSafety™, and AAV-NGSafety™, and has successfully helped multiple CGT clients' R&D pipelines pass China-US IND filings.

Unlike the traditional "one by one" approach, NGSafety™ achieves "one test, multiple capabilities": with just one experiment, it can simultaneously obtain multidimensional data such as integrated locus information, copy number analysis, sequence integrity, flanking host gene background, and potential viral contamination.

Core performance advantages are obvious:

High sensitivity: can identify trace mutations or heteroclones as low as 0.1%, far exceeding the detection limits of traditional Sanger sequencing;
Excellent accuracy: copy number detection accuracy reaches ±5%, and can detect tiny chromosomal abnormalities as small as 100kb in host cells;
Short cycle: only 1-2μg of genomic DNA is needed to directly build a library, eliminating the need for the 2-3 week subclonal step;
Data compliance: Fully electronic records from FASTQ to BAM and VCF, seamlessly aligning with GMP/GLP quality control requirements and providing a complete traceable data chain for applications.

In addition, GentleGen also possesses full-chain service capabilities in the fields of oligonucleotide drugs and mRNA drugs. For oligonucleotide drugs, the company offers one-stop services from sequence design, synthesis, screening and validation to safety evaluation, with capabilities for synthesis and purification of oligonucleotides from mg to G levels; For mRNA drugs, unique technical solutions can be used to comprehensively cover 5'UTR, CDS, 3'UTR, 3'UTR, and Poly(A) tail sequences using Sanger sequencing, providing authoritative verification of sequence integrity and authenticity.

GentleGen is committed to promoting the standardization and precision of biologics safety evaluation through NGS technology, helping pharmaceutical companies improve R&D efficiency, reduce clinical risks, and accelerate drug market launches. For more information, please contact us at: marketing@gentlegen.com.

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