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AAPS 2017: Applying QbD in Process and Impurity Control Strategy Development

Andrew Anderson, Vice President, Innovation and Informatics Strategy, ACD/Labs


The 2017 AAPS Annual Meeting kicks off this week so I’ve started to think about all the work we’ve been doing this year at ACD/Labs, and how it relates to the pharmaceutical R&D community. While our team is on-site at the show, I thought it would be a good idea to revisit a recent byline we published to Laboratory Equipment back in August. The article, titled Mitigating Risk through a Searchable Knowledgebase, focuses on how process and impurity control development teams can respond to the increasing amount of pressure global regulatory authorities are placing on them to incorporate quality-by-design (QbD) to support risk management.  

The short answer, which I elaborate on in the article, is the implementation of an impurity control informatics platform. However, the piece doesn’t specifically discuss how QbD and impurity control management directly impact process development within pharmaceutical R&D organizations. After all, AAPS stands for the American Association of Pharmaceutical Scientists so ahead of the show Joe DiMartino, our newly appointed solution manager for Luminata – ACD/Labs’ impurity control informatics platform – aimed to address this topic in an interview with You can check out the full interview here, but in the Q&A Joe discusses the evolving regulatory landscape and how companies can leverage QbD to help mitigate risk in drug development. He also explains the benefits of Luminata and how it differs from other solutions available in the market.

Here is a preview of the questions Joe addresses in the interview:

  • Why have global regulatory authorities been pushing Quality-by-Design (QbD)?
  • What are some of the regulations in place that call for a QbD approach?
  • How has an evolving drug development landscape necessitated these regulations?
  • What are the benefits of QbD in drug development?
  • How is ACD/Labs’ platform different from similar solutions?
  • What benefits does it provide customers?

Again, I encourage you to check out both articles as they provide some great insight into a trend that is shaping product development groups and their supporting corporate informatics infrastructure. Also if you happen to be onsite at the 2017 AAPS Annual Meeting, make sure you stop by booth # 1138 and say hello to the ACD/Labs team. Visit our events page for more details on what we’ll be up to throughout the show.

Finally, for more information about Luminata, check out our latest video below, which explains how organizations can cut their impurity data time investments from months into minutes.