PAT for Large Molecule

The use of Process Analytical Technology (PAT) is a well-established technique that is being used in most areas of development and production for large molecule pharmaceuticals. PAT has been implemented with great success by various companies from the R&D stages, in pilot scale plants, through to full GMP manufacturing facilities.

The technology has brought about significant benefits for biologics manufacturers, including speeding up product development and making manufacturing vastly more efficient. For example, for one of the leading biopharmaceutical company, using PAT in their process led to their titre being tripled in a batch process, with further gains anticipated as their continuous improvement learnings are implemented.

In upstream processes, the use of PAT is well established and has been reported on many times. The technology is increasingly being exploited in downstream processing to further optimize production.

For upstream processes, companies normally utilize Raman spectroscopy with great success. In downstream processing, Raman, UV Vis and UPLC remain the most commonly used instruments. New, miniaturized instruments, such as NMR spectrometers, are also advancing upstream and downstream processes. As part of this PAT system, knowledge management software is essential to bring together the disparate data collected by these sources and coordinate it in a flexible and validatable way. An example of this technology is the market-leading software, synTQ by Optimal Industrial Technologies.

The implementation of PAT in conjunction with Smart AI and control methods has the capacity to radically transform the biopharma industry. 

Bruker offers synTQ PAT management software and a wide range of instrumentation-based PAT solutions.

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‘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.