Impact of Multi-Attribute Testing in the Biopharmaceutical Industry
I was fortunate to work with Bill Paulson in writing an article Biopharma Is Working with Analytics Providers and Government Agencies to Further Multi-Attribute Method Use in QC published in IPQ (International Pharmaceutical Quality) August 7, 2017. I refer people to that article for the specifics of MAM and in this blog I will touch upon the business and strategic impact of multi-attribute methods (MAM) given the apparent inevitable implementation of MAM.
MAM utilizes mass-spectrometry to analyze biopharmaceuticals and is on the cusp of being ready for full implementation into development and QC (see IPQ article) and seems certain to become the primary biopharmaceutical method in coming years. MAM offers the potential to bringing biopharmaceuticals a significant step closer to small molecule drugs that are defined rather than characterized. Below are some of the current analytical technologies that MAM has the potential to replace in product development and QC:
SDS-PAGE and cSDS
Existing methods for glycan analysis
Various methods used to assay for purity
ELISAs used for HCP quantitation
Various identity tests
Methods used to quantitate charge variants
The economic drivers to move forward with MAM include:
Cost savings from reduced QC testing
Improved quality from using a test that tells us more about our product
The ability to retrospectively expand analysis by pulling up older data
It would be remiss to overlook a couple of hurdles MAM still needs to overcome comprehending that there are no significant technical barriers:
Establishing a history of method and instrument robustness
Worldwide regulatory acceptance and implementation
Additional implications of MAM implementation include:
Smaller QC staffing/footprint
Fewer instruments required for product development and QC testing
A shift in needed analytical skill-sets
All industries that encounter a fundamental change in business as usual corresponding to a substantial increase in efficiency are challenged by changing business practices, finding people familiar with the innovative technology and the displacement of people and companies. While large biopharmaceutical companies have systems in place to plan around the eventual implementation of MAM and the impact on lab footprint, changing technical needs, and cost to doing business, how are peripheral and smaller companies situated in preparing for the changes that will come about as MAM is implemented? Some examples of potential changes include:
Reduced need for instruments and reagents for technologies to be replaced
How does the contract industry that the biopharmaceutical industry is dependent on adjust to the change? Have these industries yet considered how to establish this new technology?
When is it prudent for smaller biopharmaceutical companies to embrace MAM? The need of smaller companies and their dependence on contract companies will require an evolution of their interdependence that will be an interesting story to watch
Maintaining older methods and the companies required to support those methods until the analytical life cycle catches up with MAM
Currently MAM is slowly being implemented by large, biopharmaceutical companies with drivers including government agencies, business leaders, and vendors heavily investing in this technology. It seems likely that MAM will be embraced first by large biopharmaceutical companies and leading regulators followed by smaller companies and world-wide regulatory acceptance. A seminal event in this story will be when any major regulatory group requires implementation of MAM based on safety/quality desires.
Note: To read the full article in IPQ requires a subscription to this journal. I recommend that people and groups look through the free IPQ online content at https://www.ipqpubs.com/ and consider subscribing to the contents.