On January 25, 2012, I attended an excellent session at the IFPAC Conference where a series of presenters including Lonza, Hovione, Merck, Pfizer, and Bristol-Myers Squibb presented the value of Process Analytical Technology (PAT) and Quality by Design (QbD) within a CRO/CMO (Contract Research Organization/Contract Manufacturing Organization).
Common to all the talks was the use of PAT such as NIR, FTIR, FBRM®, PVM®, UV, and Raman to promote continuous improvement during chemical development, crystallization, and final product formulation. These tools help lower manufacturing risks, and ensure more consistent results and lower costs. I was struck by several opportunities where PAT tools helped improve the relationship between CRO/CMO and their sponsor. Specifically, Lonza and Hovione presented ways PAT helps them lower development costs and manufacture the most efficient, and least complex process. Merck, Pfizer, and BMS emphasized the higher quality of CROs and CMOs who used PAT to improve process throughput and ensure on-time delivery.
Hovione presented how their PAT approach builds stronger collaboration with their sponsor, for technical as well as business evaluations. They presented the table below showing that when using their PAT and QbD strategy called EDaM (Excellent Development & Manufacturing), they gained much more regulatory flexibility, an 6-9% improvement in quality, reduction in batch failures, and about a 9% improvement in yield.
Hovione, Lonza, Merck, Pfizer, and Bristol-Myers Squibb presented that through the use of ReactIRTM, FBRM®, PVM® and Synthesis Workstations, they are able to optimize and scale-up unit operations such as:
- Chemical reactions
to produce products that consistently meet target purity, yield, and particle size specifications.
I invite you to view an on-demand webinar which introduces Process Analytical Technology (PAT): The “Official” Language of Pharmaceutical Outsourcing.