Umetrics has a long history in offering multivariate tools for analysis of research and production data. Early on in the definition of PAT, Umetrics presented concepts (slides and briefings are available on FDAs web) of chemometrics to the CDER PAT subcommittee. Svante Wold of Umetrics, was later invited by the FDA to assist as a member of the chemometrics working group that reported to the PAT subcommittee. Our unique strengths of 30+ years experience in the field of chemometrics and multivariate analysis (MVA) has played an important role in helping to introduce and teach others the usefulness of MVA for PAT applications.

The origins of PAT trace back to bringing measurements made in the laboratory into the production environment. Consequently PAT was initially interpreted as integrating advanced sensors into manufacturing processes. More recently PAT has grown to mean much more than sensors. Umetrics has compiled a set of tools that utilize the data generated throughout manufacturing, including these advanced sensors to provide metrics describing the state or health of a process. In pharmaceutical manufacturing unit operations are typically carried out in batches. The trajectory of these batches from initiation to completion can be summarized into a multivariate signature or fingerprint. Comparison of new batches to this MV fingerprint provides an indication of the state of the process.

An area that Umetrics is striving to contribute is the generation of a turnkey set of PAT analysis tools and integration of these with IT platforms to provide a comprehensive PAT analysis platform strengthened by our history in Pharma and experience in other industries.

If you are interested in speaking with one of Umetrics’ PAT consultants about Process Analytical Technology please contact us.