LABORATORY INFORMATICS
data from instrumentation and analytical systems from different vendors. ‘Many laboratories work with multiple chromatography systems from different vendors, each of which will use their own languages, but companies can now connect data from all the instrumentation directly to the decision support interface,’ Anderson continued. ‘This connection is also automated. We have a mechanism that monitors the data sources, and when records of interest are generated, they are automatically pulled up and pushed into Luminata, with full retention of all levels of access security, chain of custody and data transparency and integrity.’ A collective and cohesive infrastructure impacts positively on multiple areas of operation, not just the immediate product life cycle, but also on areas such as PAI (prior approval inspections), because all the data that an inspector may require, say, the last six months of batch records, is held in one system. ‘We can cut down that time of fielding questions during inspections or during data review as part of an audit.’ The firm started partnering with instrument vendors more than two decades ago to develop tools that would simplify the analytical data landscape and support fast, confident decision making. ‘Consolidation
of all the different techniques (NMR, LC/ MS, GC/MS, optical techniques and more) into the singular Spectrus platform in 2012 brought analytical data homogenisation and standardisation to scientists that rely on analytical data to help make decisions. These innovations in analytical data handling were driven by scientists’ need to assemble and connect data on a daily basis for a variety of risk-mitigating decisions.’ There are multiple benefits of data standardisation on the Spectrus Platform, particularly for the firm’s most recent product introductions, which include Luminata and Katalyst D2D (design to decision). Katalyst D2D is a web-based platform that leverages the ability of Spectrus to assemble disparate analytical data and connect it with chemical information, such as structures/ formulations, metadata and more, Anderson continued, particularly in support of high throughput and parallel experimentation. ‘For these types of tools, standardisation on Spectrus gives scientists the ability to make decisions about substance identity and purity with greater confidence – by having live, comprehensive analytical data visualised within decision support software interfaces. Streamlined data access facilitates the capability to share knowledge
in chemical context for immediate access by colleagues/partners and for informed future review. Another advantage is that assurance of data integrity through adoption of a single, common data format, and improved IT and systems integration with an informatics platform that speaks the language of analytical data,’ said Anderson. ‘Specifically for Luminata, standardisation on the Spectrus platform enables project teams in product development to build ‘effective control strategies in CMC with access to vast quantities of live analytical data that is connected and assembled to support those workflows,’ Anderson said. ‘Katalyst D2D supports high throughput experimentation workflows from experiment design through execution, to high throughput analysis and connection of analytical results with each well of an array. The alternative of not having such an
interface requires scientists to seek data from a variety of software interfaces. Katalyst D2D is built upon the Spectrus Platform, so in addition to users benefitting from having a single software interface across their experiment lifecycle, Katalyst D2D users will also offer the added benefit of data integrity – which their current systems may not afford,’ Anderson concluded.
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28
