Manufacturability verification and optimization

Pharmaceutical companies must adopt digital technologies for manufacturability verification and optimization to ensure a smooth transition from lab to production. Traditional methods are slow, costly, and prone to failure, leading to delays in drug availability. Embracing digital technologies in the lab enhances efficiency by bridging the gap between R&D and production, using simulations and digital twins to optimize processes, reduce risks and ensure regulatory compliance. This approach has successfully helped companies like Johnson & Johnson Innovative Medicine to scale up production while minimizing costs and improving sustainability.

Verify the manufacturability of medicines early in the drug lifecycle in two steps

There are two key steps to verify the manufacturability of medicines early in development to reduce risks and streamline the process: the site capability check followed by the actual tech transfer. The site capability check will capture data from production equipment across all sites and lines and recommend the ideal site and manufacturing lines to best produce the General Recipe. Once a site is determined, the Site Recipe is created, which is the actual tech transfer and includes the use of digital twin simulations to assist with the scale-up and scale-down rules.

By deploying process design and tech transfer, pharma companies can accelerate recipe development, enhance drug manufacturability and scale up from lab to production. Read the ebook to learn more.