Case Study: Bayer achieves automated, GMP-validated oligonucleotide QC with Genedata Expressionist (Genedata)

Automating QC of Therapeutic Oligonucleotides in a Regulated Manufacturing Environment

Bayer Pharmaceuticals, a long‑term Genedata customer since 2006, needed to implement a validated QC identification (ID) test for novel oligonucleotide drug substances to support release testing and imminent clinical trials. The challenge was to translate an Ionis LC‑UV‑MS SOP into Bayer’s QMS within a tight timeline and a GMP environment, requiring vendor‑agnostic software that could integrate UV and MS data streams, automate complex calculations, and ensure data security, integrity, and traceability.

Genedata implemented an automated end‑to‑end workflow using Genedata Expressionist® that integrates raw LC, UV, and MS data, runs system‑suitability checks with traffic‑light reporting, and can be locked down for GMP use (user authentication, audit logs, digital signatures). The solution was delivered on time and within budget, reduced data‑processing time by several hours, eliminated manual calculation errors, improved reproducibility and confidence for QA review, and enabled rapid Computer Systems Validation and deployment of the ID test into Bayer’s QC environment.

Bayer

Juliet Padden

Laboratory Head Analytical Development