Merck Launches First-in-Class Integrated Genetic Stability Assay to Accelerate Biopharmaceutical Testing

Merck, a globally leading science and technology company, officially launched the first integrated and validated genetic stability analysis on April 16. Benjamin Hein, Global Head of Life Science Services at Merck's Life Science business, stated that the Aptegra™ CHO Genetic Stability Analysis leverages whole-genome sequencing and bioinformatics to significantly accelerate customers' biosafety testing, enabling them to move into commercial production.

Merck Life Science Business Life Science Services

Global Head, Mr. Benjamin Hein

Hein emphasized"Driving innovation in biosafety testing is crucial for bringing new therapies to patients more quickly. The genetic stability testing of CHO has remained relatively unchanged for many years."

The Aptegra™ platform transforms biosafety testing with a digital solution for next-generation sequencing.

Currently, the FDA's guidelines require biotech companies to use multiple testing methods to meet genetic stability requirements. Hein explained that these traditional testing methods are both expensive and time-consuming, and often lead to the need for additional support and explanation of the data.

"The Aptegra™ platform utilizes next-generation sequencing technology, replacing five different tests and four different technologies with a single test, addressing these pain points," he continued. "This method reduces testing time by 66% and cuts costs by 43% compared to traditional methods. The platform meets all regulatory requirements for genetic stability assurance, including copy number assessment."

Merck has made investments over the past five years to expand its capacity for biologics safety testing for global customers. The company’s global biologics safety testing network includes Shanghai, China; Singapore; Sterling and Glasgow in the UK; and Rockville, Maryland in the US.

Genetic stability testing is included in the Cell Line Characterization (CLC) when the evaluated cells have been stably transfected with genetic elements producing biologically relevant products, such as monoclonal antibodies or their related subunits. The entire CLC test package is applied to the Master Cell Bank and repeated for cell banks expanded from this primary material. The tests conducted include the following methods:

Traditional genetic stability test packages adopt the following four methods:

Our innovative Aptegra™ The platform, co-developed by laboratory scientists and bioinformaticians, provides an extremely advanced tool that delivers highly comprehensive genetic stability testing results with a single test. Aptegra™ CHO genetic stability analysis can be completed within 30 days, saving a significant amount of time compared to the 3 to 5 months (minimum) required using traditional methods. Moreover, traditional methods necessitate repeated testing with different primers for each heavy and light chain subunit encoding the monoclonal antibody; Aptegra™The test has no such limitation and does not require prior notification of the relevant sequence information, which means we can analyze multiple genes encoded on a single vector expression system by running one test.

We offer a comprehensive, GMP-validated genetic stability analysis, the first of its kind based on whole-genome sequencing. We not only provide integrated analysis and sequencing analysis to detect variations within sequences but also offer the ability to assess copy number variations. The evaluation of copy number is a unique feature that remains largely unexplored by the industry in the context of whole-genome sequencing, setting us apart from others. As a fully GMP-validated analysis, the Aptegra™ platform provides our customers with a more complete, reliable, and trustworthy solution.