Subscribe
  
IPQ Inside the global regulatory dialogue

Biopharm Modeling and Continuous Manufacturing Will Help Drive Vertex’ Drug Development and QbD

Jun 22nd, 2012

Please Log in to print the full article

Vertex is focusing on biopharmaceutics modeling and continuous manufacturing as potentially powerful tools for advancing its drug development and quality by design (QbD) program.

In the context of oral solids, Vertex sees the potential for biopharm modeling to help develop an in vitro dissolution test that accurately predicts what happens in vivo, which will speed drug development and allow reduction of the number of PK studies that need to be performed in animals.

In turn, the firm believes that the use of a continuous manufacturing process that can be implemented at both development and production scales will provide decreased variability and cost savings by reducing or eliminating QC testing, utilizing a smaller footprint, and improving yield.

At a symposium sponsored by the International Consortium for Innovation and Quality in Pharmaceutical Development (IQ Consortium) in December in Cambridge, Massachusetts, Vertex Senior VP for Pharmaceutical Development Patricia Hurter highlighted the attention Vertex is placing on biopharmaceutics modeling and continuous manufacturing and explained their potential to spur the drug development process down a quality-by-design pathway.

[The story continues for subscribers beginning on page 2.  Nonsubscribers can purchase the story for $195 by contacting Wayne Rhodes ([email protected]).  For subscription/license information, click here.]

See related IPQ stories:

Vertex Harnesses QbD to Solve Difficult Formulation and Manufacturing Issues

Virtual Innovator Vertex Pioneers New QbD Course with CMO Partners

Pages: 1 2

    ©2021 IPQ Publications