Top tips for providing the right amount of detail in first-in-human common technical documents
In the early-development stage, little may be known about a drug’s characteristics. What’s more, drug processes and formulations frequently evolve as more information emerges following testing and trials. Learn more.
Moving from vials to prefilled syringes for vaccines: Three key success factors
As pharmaceutical companies become more patient-centric and self-administration of injectable drugs continues to increase, the market for drug products in prefilled syringes is forecast to grow, reaching $9.53 billion by 2026.
Continuous Manufacturing: An Efficient Way to Produce OSD Drugs
When Henry Ford revolutionized manufacturing practices back in 1913 in Highland Park, MI, his main goal was simple—to make the best possible product in the most efficient and cost-effective manner. Ford’s focus on bettering the “flow” of manufacturing to enable workers/technology to work smarter and reduce waste of raw materials, changed manufacturing principles forever.
COVID-19’s Silver Lining: Accelerated Vaccine Development
Vaccine development is a lengthy process—it is expensive, attrition is high, and to get a licensed vaccine to everyone, it takes multiple candidate iterations. Vaccine development for pandemics and epidemics is risky, and due to the novel nature of viruses, certain unknown factors can derail a vaccine program.
Considerations and roadblocks that stifle orphan drug development
According to the US Food and Drug Administration (FDA), “2020 was a record-breaking year in terms of the number of orphan drug designation and rare pediatric disease designation requests submitted to the Office of Orphan Products Development.”
It’s no secret—consumers have a vast range of OTC options at their favorite in-store or online retailer. Everything from tablets and capsules, to syrups—consumers have more options than ever in the OTC jungle.
Navigating the Complexities of Process Performance Qualification
Method qualification is monumentally important before process performance qualification (PPQ). This early assessment of your method’s performance characteristics is critical as it pertains to method validation and its parameters such as precision, accuracy, and linearity.