May 15-17, 2018
Seaport World Trade Center, Boston, MA, USA
Related presentations, posters, and scientific talks from this event have been posted here for your reference. Please click the associated link to download.
Challenges in consistent, correct, and comprehensive characterization of R&D materials and processes, G.A. McGibbon; S.K. Bhal; A.A. Anderson; J. DiMartinoDownload
Challenges in consistent, correct, and comprehensive characterization of R&D materials and processes
Graham A. McGibbon; Sanji K. Bhal; Andrew A. Anderson; Joe DiMartino
Abstract: Pharmaceutical R&D organizations rely extensively on analytical data about materials and processes as they strive to bring innovative products to market. Even with digital data, a key challenge to analyze and integrate it effectively arises when assembly of results from different complex data sources is necessary for achieving consistent, correct, and comprehensive interpretation. An example of this is the management of impurities data, which is essential in the development of new therapeutics. Across process optimization and scale-up operations, batches of material will be produced and then analyzed by a variety of techniques, each with their own proprietary data encoding. Consistent metadata describing experimental equipment, methods, materials and processes are also vital for ensuring the quality data is available to describe batches of drug substances and drug products. Data integrity must be maintained while also enabling re-processing, reporting, and re-use throughout the product lifecycle and when sharing between sites and organizations. In this poster we highlight analytical data management software that facilitates action to reduce risks using insights about impurities.