Conformia helps ICH QbD implementation
Conformia's platform was developed in response to data from the "Ace Case Study," which was carried out to assist pharmaceutical firms with implementation of the guidelines and standards issued by the ICH.
During the project, Conformia worked on the development of dummy drug molecule known as "Acetriptan" with several major pharmaceutical firm's including GlaxoSmithKline (GSK), AstraZeneca, Eli Lilly and healthcare major Abbott Laboratories.
The multidisciplinary team employed ICH guidelines (Q8/Q9/Q10) to all aspects of the product/process development life-cycle, eventually creating a detailed case study that has been widely adopted as an implementation model by the drug industry.
Anjali Kataria, Conformia founder and CMO, said that: "One component of this [QbD] paradigm is the knowledge management across the lifecycle and Conformia's Design Suite is the first software system to embody key elements of the Quality by Design paradigm and will help companies achieve the benefits of the ICH Quality Vision."
She added that: "While it isn't going to bring the entire paradigm to life, it certainly will assist companies in more rapidly adopting the paradigm by filling critical information and knowledge management gaps across the product and process lifecycle, and will help bring other technologies forward such as PAT, platform based development, Design-Automation and analysis tools."
Within the wider drug industry, demand for ICH-compliant design solutions has increased considerably in the last few years. A recent survey by US market research group AMR revealed that around 75 per cent of drug companies either have or are planning to have ICH QbD programs in place in the next six months.
AMR's research director Hussain Mooraj commented that managing design space and risk analysis in an organised manner that promotes knowledge and efficiency has been identified as a key factor in successful ICH implementation.
Reduce development risk
Conformia explained that its new design suite system had been created to provide pharmaceutical firm's with an ICH Q8/Q9/Q10-compliant centralised storage database that allows biologists, chemists and other groups involved in the drug development process to share data.
The firm believes that the platform, which is designed to complement its other life-cycle management offerings, will help drugmakers reduce development cycle time, expenditure and overall risk
"With the introduction of the Conformia Design Suite, companies can achieve new levels of collaboration and efficiency," said CEO Joe Prang.
"Conformia continues to set standards in automated, Web-based solutions that simplify the design, development and transfer of knowledge in pharmaceutical design."
