We've been climbing the CMC Development mountain in the past few weeks, each session we picked a different track...
We spent a great deal on Manufacturing Process development - starting with the meaningful transition from the Discovery stage to the 1st GMP batch, following with the evolution of the process until it reaches its final shape, with occasional stops for scale-up, comparability, tech transfers and the endless effort of product characterization and impurity profiling..
We then went back down to see the first steps of Pharmaceutical Development- how the product will be delivered to the patient, and the foundations to what will later become our Commercial product. We saw how the analytical profile of the product stretches from the earliest IPCs all the way to Release and Stability and the vast array of Analytical Methods at our disposal- establishing a multidimensional body of data serving us to better understand our process and product over time. Our last camp was to see how the product reaches the real-world- we discussed Stability and Shelf-life, Good Distribution practices, and got a small taste of the daily life of CMC operations (this is when we met The CMC Superhero, usually found in small startups- look her up, she looks just like any one of us). And before we made the final push towards the summit- we spread the safety net of Quality, harnessed ourselves well with some solid Guideline definitions of it, and saw how they evolved over the years. From the “Quality by Testing" elaborated in ICH Q6A and the "organized arrangements" and Quality Management Systems depicted in the GMPs, and all the way through to the current state-of-the-art paradigms of Quality Risk Management and Pharmaceutical Quality Systems. And then- there it was, the peak of the mountain: Process Validation! We saw where the magic number “three batches” come from in the traditional approach, and how with today's complex products and processes, there is really no way around using Risk-based and Science-based approaches, as reflected in the concepts of Quality by Design. We broke our teeth with discussions on QTPPs, CQAs, CPPs, CMAs, PARs and NORs, and to celebrate our achievements, we saw some beautiful pictures of Design Spaces. In the last week we enjoyed the views from the top a little more and looked again at our Module 3 roadmap to make sure we haven’t forgot anything. We took a short glimpse to the near and far future of CMC and Pharmaceutical Development, with the advent of Big Data technologies enabled by PAT (Process analytical technology), IoT, Blockchain, and… no way around it: Artificial Intelligence. We saw the weird and interesting challenges ahead of us, when we will need to validate autonomous, self-learning systems....
And with that, the course was over, and is now available on-demand for anyone who missed it. See details here.