Allotrope Foundation, an international consortium of pharmaceutical and biopharmaceutical companies with a common vision to develop innovative new approaches for handling data in R&D, has released the first production version of its Allotrope Framework to Allotrope Foundation and Allotrope Partner Network members. The September internal release package includes version 1.0 of the Allotrope Data Format (ADF), the Application Programming Interfaces, (APIs), and the Allotrope Foundation Taxonomies (AFTs), marking the successful completion of the early phases of development. Designed for Allotrope Foundation by Osthus, an information management and technology services firm, the Allotrope Framework is an advanced data architecture that facilitates the creation, use and exchange of laboratory data by standardizing data representation across proprietary equipment and software.

Realizing The Vision

Members of Allotrope Foundation, in collaboration with members of the Allotrope Partner Network, have already begun to implement software solutions that integrate the Allotrope Framework into their laboratory workflows and enable adoption of the Allotrope Data Format, that enables software to access any data from any analytical instrument regardless of manufacturer or software version.

“The progress on the Allotrope Framework to date has shown significant promise in developing the tools that provide a standard file format and terminology for describing the data and workflow of the analytical laboratory in the software used to generate and analyze that data” said Dr Dana Vanderwall, associate director, Cheminformatics at Bristol-Myers Squibb. “We have initiated a project to develop a standard platform for the planning, execution, analysis and reporting of analytical chemistry across Discovery Research at Bristol-Myers Squibb that will reduce the friction in the process of using data for decision making and insight by leveraging the Allotrope Framework as a fundamental part of the infrastructure.”

GlaxoSmithKline (GSK) will implement the Allotrope Framework for use in drug substance release and stability testing in research and development (R&D) as a first step towards wider integration into multiple workflows across R&D and manufacturing environments. The Allotrope Framework and Allotrope Data Format are expected to drive automation and enhancement of data quality, compliance and integrity. GSK’s integration project encompasses the entire data lifecycle, including sample receipt, analysis, review and approval and long-term preservation. “Every decision we make about our products is based on data. To deliver safe and efficacious medicines to the patient, we must be confident in the quality and integrity of our data. Our integration project with Allotrope Foundation will deliver standard metadata and data stored in a standard format, addressing the root cause of our data challenges and revolutionizing the way we generate, access and use data to make decisions and deliver our pipeline of medicines,” said Dr Annette Doherty, senior vice president, Product Development & Supply.

Roadmap for the Allotrope Framework

The development of the Allotrope Framework is an ongoing project. In addition to the V1.0 elements of the ADF, APIs, and AFTs, the design of the Allotrope Framework includes a comprehensive metadata repository built on the taxonomies and a more complete range of API functionality in the form of the class libraries. The generally available release of the full Framework is scheduled for the fourth quarter of 2016.