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The pharmaceutical industry faces unprecedented challenges in bringing life-saving medicines to market. According to the Tufts Center for the Study of Drug Development, the cost of bringing a new drug to market can exceed $2.8 billion when accounting for capital and trial failures. In this high-stakes environment, every stage of development must be optimized to…

For small- to medium-sized pharmaceutical companies and start-ups, time is currency. Every day delayed on the path to IND not only postpones patient access to potentially lifesaving therapies but also incurs significant financial cost and dilutes investor confidence. Furthermore, the pace of technological advances today (i.e., artificial intelligence and machine learning development) is leading to…

– “Dig Your Well Before You’re Thirsty.”(A Chinese Proverb) The key to a successful inspection? Be prepared long before inspectors arrive at your door.  Companies that maintain inspection-ready systems, well-trained personnel, and organized documentation experience smoother inspections with fewer findings. Pharmaceutical inspections are inevitable; life sciences organizations know that FDA inspections are like trains; there’s…

Introduction When the U.S. Food and Drug Administration (FDA) conducts inspections of regulated facilities, it often issues an FDA Form-483—also known as an inspectional observations form—when it identifies areas of non-compliance. Receiving an FDA-483 can be challenging for companies, clinicians, and CROs, as it highlights deficiencies that must be urgently addressed to avoid enforcement actions…

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…