Amgen is among the major biotech companies working hard on empowering, while at the same time streamlining, their analytical toolbox at the development and quality control testing levels as the next frontier of quality by design.
How to realize “the promise of analytics of the future” using what Amgen is calling “multi-attribute methodology” (MAM) was the theme of a presentation by the biotech company’s Contract and Product Quality VP, Anthony Mire-Sluis, during a session focused on QbD implementation challenges at CASSS’ CMC Strategy Forum Europe held in Sorrento, Italy in May 2014. Prior to joining Amgen in 2004, Mire-Sluis played a key role in biotech CMC policy setting at FDA.
At the session, he revealed: ● the purpose and rationale of Amgen’s MAM program ● how the vision was pursued using mass spectrometry (MS) methodology ● examples of its power in assessing product quality attributes, and ● the regulatory implications in moving to its use in specification-setting and routine QC testing.
The presentation shed light on the issues that come to the fore as the rapidly advancing analytical technology pushes up against existing biotech regulatory policies and on the adjustments that need to be made to accommodate these advancements. As such, it speaks to the intent of the CASSS CMC strategy forums as a vehicle to bring industry and agency experts together to explore biotech developments and the regulatory concerns they engender.
Also presenting at the session were Sweden Medical Products Agency (MPA) biotech product assessor Mats Welin, who offered “a regulator’s view” on “how to assure quality and consistency in an evolving QbD scenario,” and MedImmune UK’s Derek Murphy, who addressed the impact of QbD on QA and the Qualified Person (QP).
A significant discussion period followed the presentations that focused heavily on Amgen’s single multi-attribute method approach and the regulatory issues it raises.