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Posted On: 02/24/2005
UMetrics, TCIVega Partner to Provide Integrated PAT Solutions
Umetrics AB and TCGIvega have formed a partnership to provide integrated solutions for PAT in the pharmaceutical industry. The alliance enhances Umetrics’ leading competence and software suites in multivariate/chemometrics analysis by adding TCGIvega’s strong skills in data architecture design and integration.
The objective of this partnership is to address the need for seamless data connectivity in the PAT domain. Currently, many pharmaceutical and biotech companies have separate data architecture systems such as MES (Manufacturing Execution System), LIMS (Lab Information Management System), and SCADA (Supervisory Control and Data Acquisition) systems. It is increasingly difficult to connect these systems for the purpose of data analysis and process monitoring.
As outlined by the FDA, one objective of PAT is the multivariate analysis of real-time production data – whether in development and scale up, or in final production. This requires combining the information in all of these data systems. The strength of TCGIvega is extensive experience with integration of data systems in the life sciences industries. This partnership now extends the integration to include Umetrics’ real-time and off-line multivariate software. Data will flow seamlessly from source to analysis and visualization. Umetrics’ senior consultants will manage these projects and remove the stress from the pharmaceutical production facilities.
The solution (“Umetrics’ PAT Suite”) will be available to both production (primary and secondary manufacturing) as well as R&D environments where pharmaceutical and chemical development use multiple data sources.
“This partnership is a key step forward for Umetrics and our PAT product offerings,” says Umetrics’ CEO Lars Osterberg. “Given the ability to harness all data sources simultaneously, in a robust and validated environment, our PAT solutions will perform process monitoring of all parts, from raw materials and API synthesis, to final product quality control. This is a unique offering in the industry.”
TCGIvega CEO Giri Devanur adds, "Our strength in the enterprise integration space and our long history in life sciences nicely dovetails with Umetrics’ unique PAT offerings, making for a true end-to-end solution." Alluding to the DataLync real-time database connectivity product that TCGIvega is developing in collaboration with Umetrics and a major pharmaceutical company, Devanur observes, "It completes the missing 'lync' that has been befuddling PAT practitioners.”
With over 17 years of experience of providing multivariate data analysis software to the pharmaceutical industry, Umetrics’ products are uniquely suited for the PAT initiative. These products include SIMCA-Batch On-Line and SIMCA-P+.