Author: robert

As oligonucleotide therapeutics development accelerates due to advances in chemistry and delivery technologies, understanding how to ensure quality of oligonucleotide Active Pharmaceutical Ingredients (APIs) and Drug Products (DPs) becomes crucial. This includes anticipating regulatory expectations, beginning with good science and understanding the drug development process. Responsibilities of Sponsor and Vendors Many start-up or mid-size life…

Introduction Advancements in RNA therapeutics are increasing the demand for high-quality synthetic oligonucleotides including siRNA (small interfering RNA) and sgRNA (single guide RNA). While conventional solid-phase oligonucleotide synthesis (SPOS) remains the primary method for siRNA and sgRNA production, its limitations in scalability, sustainability, quality, and cost hinder its ability to meet the anticipated market demands….

An article examining recent GMP inspection data from two prominent regulatory bodies notes that “Deficiencies in investigations remains at the top of this list over the past four years. We as an industry cannot seem to get this quite right.” I agree. Here’s why.