Aimee Hodge, VP business operations development & manufacturing at PCI Pharma Services discusses PPQ pitfalls and how to avoid them.
PCI Pharma Services
For just a moment, let’s imagine we remove our pharma engineering hats and slip into… running shoes. Let’s swap out our dedication to drug development and manufacturing and replace it with weeks, months and even years of physical training all for one goal: completing a marathon.
To say you’ve put in the work is an understatement. Long hours in the gym, longer hours on the track. Trading pizza for protein shakes and carrot cake for, well, carrots. Running through pain, rain and strains to gain that extra advantage on the lengthy, 26.2-mile road to a remarkable physical feat. Rounding the final corner, the checkered banner of the finish line comes into view. What a welcome sight.
So welcome that you stare into the distance long enough to veer off the roadway and headfirst into a lamppost. Goodbye marathon, hello hospital.
The process performance qualification (PPQ) stage
OK, pharma development hats back on. In our neck of the woods, such snatching of defeat from the jaws of victory closely resembles a drug development journey that travels great distances before stalling out in the process performance qualification (PPQ) stage.
Up to that point, the drug project has passed several key milestones. For new small molecules and biologics, rigorous multi-phase clinical trials are wrapping up. For ANDAs, a complex reverse engineering process has led to a generic product that stands up to its brand name big brother. Everything seems ready for the final push to commercialisation, the crossed T’s and dotted I’s of a resource-rich project years in the making.
And then it isn’t. And worse, the reasons were, like that lamppost, entirely avoidable. Let’s explore a few case studies where the path to commercialisation took unfortunate detours at the least tenable time: the final runup to approval and launch. In the process, we’ll discuss best practices that can help keep drug approvals on course for the winner’s circle.
PPQ pitfalls can arise stemming from insufficient or incomplete communications with regulatory agencies regarding a product’s expectations or not conducting detailed risk assessments and corresponding remediation plans.
Adhering to a tried-and-true set best practices during the PPQ-stage can prevent a drug approval from stalling out on the final lap. For starters, you should seek to establish an ironclad protocol for commercial supply agreements that sets clear parameters for drug substance continuity and, most importantly, quality. Only with the proper product ingredients in hand can a manufacturer make informed decisions on the next step: finalising CQAs and, relatedly, a buttoned-up process failure mode and effects analysis (PFMEA).
Next, stick the landing on a final process validation campaign. Such a systematic procedure is crucial to ensure a manufacturing process can consistently produce quality products. Subsets of this step include drug product stability registration, continuous process verification and, furthest downstream, packaging and shipping validation.
Collaboration is Key
The final item in our best practices collection should be bolded, CAPPED and scrawled across the top of the checklist for any pharma company engaging a contract development and manufacturing organisation: COLLABORATE WITH YOUR CDMO.
In the end, what your CDMO doesn’t know can hurt you even more than a faceplant into a lamppost. The due diligence that you undertake when selecting the right CDMO takes outsized effort; the process should, at least, consider prior experience with similar formulations, the ability to support both short- and long-term needs, depth of development capabilities and, per our purview here, process for onboarding new products and assisting with regulatory submissions. Now, put that sound decision to hard work.
Above all, this means bringing that CDMO as fully into the process as possible. Details matter. In the marathon that is drug development, approval and commercialisation, there’s no ribbon for a second-place finish.