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实例探究 > Automating QC of Therapeutic Oligonucleotides in a Regulated Manufacturing Environment

Automating QC of Therapeutic Oligonucleotides in a Regulated Manufacturing Environment

技术

分析与建模 - 数据即服务
应用基础设施与中间件 - 数据交换与集成

适用行业

药品

适用功能

质量保证

用例

质量预测分析
监管合规监控

服务

数据科学服务
系统集成

挑战

Bayer Pharmaceuticals obtained an exclusive license from Ionis Pharmaceuticals to develop new oligonucleotide-based treatments for a wide range of medical conditions. To support release testing and the imminent clinical trials of an advanced drug candidate, the Bayer Analytical Development Team for Biologics was tasked with implementing a validated drug substance and drug product release ID test that required establishing new analytical methods, standard operating procedures, and organizational responsibilities. The tight go-live timeline and anticipated costs of any delay led Bayer to work together with our long-term partner Genedata to develop a confirmatory identification (ID) workflow of oligonucleotide species by mass spectrometry so that an approved quality control (QC) could be implemented and validated by Bayer’s Quality Assurance (QA) team. The main challenges were implementing an oligonucleotide analytics workflow, satisfying GMP requirements, and meeting a wide range of new analytical demands.

关于客户

Bayer Pharmaceuticals is a company that focuses on researching, developing, manufacturing and supplying specialty-focused innovative medicines that provide significant clinical benefit and value. The company obtained an exclusive license from Ionis Pharmaceuticals to develop new oligonucleotide-based treatments for a wide range of medical conditions. To support release testing and the imminent clinical trials of an advanced drug candidate, the Bayer Analytical Development Team for Biologics was tasked with implementing a validated drug substance and drug product release ID test. This required establishing new analytical methods, standard operating procedures, and organizational responsibilities.

解决方案

Genedata Expressionist enabled timely implementation of highly customized MS solutions and thus the Ionis SOP could be swiftly translated into an automated end-to-end data processing, analysis, and reporting workflow. Together with Genedata consultants, Bayer further optimized the workflow at every processing step to meet its analytical needs and ensured compliance in Bayer’s regulated downstream operations, while adhering to the SOP. The ID test was based on analytical measurements that used MS and UV data independently and in combination. As an open and vendor-agnostic platform, Genedata Expressionist integrates seamlessly into the entire analytical process and enables Bayer to directly import and process raw data from different instruments and combine these data streams in a single analytical measurement. The Genedata Expressionist workflow developed for this project automatically determined the first acceptance criterion (the oligonucleotide ID) by reporting the m/z value of the main peak.

运营影响

The inherent flexibility of Genedata Expressionist allied with the expertise of the Genedata scientific and technical consulting team delivered an analytical process that met all Bayer's requirements and was implemented and rolled out on time and within budget.
The ability of Genedata Expressionist to integrate multiple data streams facilitated a one-to-one translation of the existing SOP into a fully automated workflow that after training and validation could be performed by routine users.
Full automation of the workflow not only ensured compliance with the SOP, but by eliminating manual process bottlenecks, also dramatically reduced data processing time by several hours.

数量效益