CMC Group Publishes Perspectives on Quality by Design
The Frontage Chemistry Manufacturing and Controls group had its perspectives of the Quality by Design (QbD) approach to drug development published in an industry journal.
The title of the article is “Considerations for strategic partnering with CRO/CMOs: Incorporating QbD in early stages of product development can be key to expediting your project successfully." To view the full content, please click here. Thank you.
Published in the May 2012 issue of Pharmaceutical Online, a Life Science Leader publication, the article is abstracted here:
“Upon identification of a lead candidate, several hurdles must be overcome to ensure the successful delivery of the molecule to the target site of treatment. Physico-chemical properties of the drug substance that can create challenges for the delivery of the molecule include solubility, membrane permeability, stability and interactions with formulation excipients.
Developing a rational formulation development strategy that is creatively designed to efficiently overcome such challenges is essential. This rational strategy incorporates QbD during early stages of the drug development process, leading to quick prototype development by identifying critical product attributes, process parameters, material attributes and operation controls required for the formulation and its manufacturing process.
Implementing a rational, stepwise approach to QbD throughout the preclinical and clinical stages of product development will allow the development team to create an optimized formulation and a robust, scalable process. earlier in the timeline and may avoid the potential for clinical failure of the candidate due to bioavailability or absorption issues.”
Reference: A Shaw, V Ketkar, V Yadwad, R Connolly, Frontage Laboratories, Inc. Considerations for strategic partnering with CRO/CMOs: Incorporating QbD in early stages of product development is the key to success. Pharmaceutical Online, May 2012.