01.12.21 -- Reducing Risk In Transferring Vaccine Production

As COVID-19 vaccine development and manufacturing has rightfully become a global priority, it has left other vaccine producers and public health organizations searching for manufacturing capacity. Facilities committed to COVID-19 production are forcing non-COVID-19 vaccine makers to shift their production needs to other facilities, requiring a technology transfer in each case. 

Capturing the right information early demystifies the development process, especially for drugs with HPAPI components. Gathering, organizing, and understanding critical risk data related to HPAPIs and cytotoxic drugs ensures that appropriate controls are defined, from concept to clinical batch manufacturing to commercial-scale manufacturing. 

The pandemic has broadcast a loud call for bringing our nation’s pharmaceutical healthcare supply chain back to the United States. Bringing it home will provide greater regulatory control and patient, economic, and workforce benefits.

With nearly 90 percent of developmental pipeline drugs consisting of poorly soluble molecules, formulation experts must address this obstacle by applying approaches to improve an API’s pharmacokinetics. 

The concept of quality by design (QbD) asserts that quality be designed into a drug based on an understanding of the product and the process by which it is developed and manufactured. This article focuses on how QbD is applied to research and development (R&D) to drive better results throughout the drug development process.