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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….

“Retrofitting quality into a biotech firm is the worst thing you can do … Thinking you can do quality later is the biggest lie people tell themselves.” — A Chief Science Officer Quality has a less than positive reputation in some corners. People see quality as something that can stifle progress. In fact, part of…

When it comes to GxP regulation, if it wasn’t documented, it didn’t happen … and that’s a problem for the quality teams who pour countless hours into keeping their companies compliant. When the auditor arrives, the only thing that matters is proof. Unfortunately, massive spreadsheets and stacks of paper files that take time to sift…

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.

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.

In the September issue of the FDA Group’s “Insider Newsletter,” Dr. Carmody discusses FDA’s proposed Quality Metrics program, new expectations for device cybersecurity, and a warning letter citing faulty study data. Find the story here.  

    Judy Carmody, PhD – Founder and Principal Consultant, Carmody Quality Solutions, LLC. Affiliations: Member, Society of Quality Assurance (SQA), New England Regional Chapter Society of Quality Assurance (NERCSQA), Association of GXP Excellence (AGXPE), and Women in Bio   A Roadmap to Quality: Performing CMC Activities with an NDA In Mind Oligonucleotide therapeutics development continues…