Standardization Leads to Agility Leads to Speed

How does standardization of aseptic filling accelerate drug development? Traditionally aseptic filling processes were developed as a custom solution late in the drug development process, often dedicated to a single drug candidate. That approach is less often successful, as drug candidates can fail, leaving companies with equipment that can’t be used for other purposes. Standardized flexible systems that fill drug into any type of dosage container can solve this problem. The impact of standardization doesn’t stop there. It has benefits other than reducing the risk of unnecessary custom equipment. It allows for lean manufacturing of the equipment, drastically reducing lead times. Standardization allows the development of a shared body of knowledge, allowing end-users to collaborate across companies. A network of standardized systems simplifies technology transfer and even allows the development of common regulatory strategies. This presentation will highlight case studies from several companies that used standard aseptic filling systems to accelerate their drug development.