PAT for Small Molecule

Process Analytical Technology (PAT) has been used extensively in the development and manufacture of small molecule drugs, which make up the majority of the pharmaceutical products currently in use. Many well-known products are manufactured with a PAT-enabled process.

For small molecule pharmaceuticals, PAT can increase the range of acceptable raw material suppliers, improve product quality and productivity. It can also significantly reduce cycle times, the amount of rejected material, work-in-process materials and in-process testing.

The optimal way to apply PAT is with a holistic approach, starting in the R&D or pilot plant stage, through to the manufacture of the final product – keeping the product lifecycle and manufacturing unit operations fully controlled and monitored. In reality, many companies start with smaller deployments and ‘islands of PAT’, which grow as more systems are added, then the technology is expanded, and skills are developed. Return on investment (ROI) opportunities are available at every stage – even for these small-scale, initial deployments.

Many small molecule processes take this ‘small PAT application’ approach for their first venture into PAT. If there is no PAT experience inside the organization, then it is likely the most appropriate route. This project will act as a teaching aid as well as deliver tangible business benefits in its own right. Once more is understood about the product and PAT technology, then it is applied more extensively throughout the business. Aside from the investment in new technology, the shift towards a PAT approach also involves a cultural change, as the process moves away from the traditional Quality by Testing (QbT) approach.

Bruker offers a wide range of instrumentation-based PAT solutions and recommends synTQ , the instrument agnostic software package from Optimal Industrial Technologies.

Free eBook:

‘QbD & PAT for Dummies’ offers a simple and easy to follow guide on what Quality by Design (QbD) and PAT are, the regulatory framework supporting these approaches, as well as how leveraging these concepts can positively transform production processes and quality testing.

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