Development of a Public-Facing Quality Control Workflow for Oligonucleotide Manufacturing

My project focused on evaluating and simplifying quality control (QC) workflows used in oligonucleotide manufacturing. Oligonucleotides are short synthetic strands of nucleic acids that are widely used in biotechnology applications such as PCR, gene synthesis, molecular diagnostics, and therapeutic development. Because these products are used in highly sensitive scientific and clinical applications, manufacturers rely on extensive QC processes to ensure product identity, purity, consistency, and overall quality.

The primary objective of the project was to develop a simplified, public-facing QC workflow model that improves accessibility and understanding while maintaining scientific accuracy. Existing QC workflow diagrams are often highly technical and visually complex, incorporating multiple analytical techniques, overlapping process stages, and specialized terminology that can be difficult for non-technical audiences to interpret. The project aimed to address this communication gap by identifying core QC stages and organizing them into a more structured and user-friendly framework.

To accomplish this objective, publicly available industry workflows, regulatory guidance documents, and technical literature were analyzed to identify common manufacturing and analytical processes used in oligonucleotide QC. Key workflow stages—including raw material verification, synthesis, purification, analytical testing, data review, and final product release—were mapped into a simplified format. Analytical techniques such as RP-HPLC, capillary electrophoresis (CE), and LC-MS were also associated with specific QC stages to demonstrate how quality is evaluated throughout manufacturing.

The final outcome of the project was a dual-level communication framework consisting of a simplified workflow diagram and a more detailed analytical mapping. Together, these resources were designed to improve interpretability, reduce potential miscommunication, and support more effective scientific communication within biotechnology manufacturing and quality systems.