As a member of the biopharma field you have probably experienced the excitement surrounding cell and gene therapies and heard about the success of early CAR-T therapies.
They are the next big leap forward toward more personalized, and more effective medicines, and a potential game-changer for the treatment of bloodborne cancers, autoimmune diseases, and more. As of 2017 more than 800 of these therapies were already in clinical trials worldwide. No matter the size of your organization you still face similar challenges in scaling up your processes. One of your biggest risks has traditionally been the translation of the automation from benchtop discovery and process development to the manufacturing suite. Unlocking a solution to this long-standing problem is one key to delivering on the promise of cell and gene therapies.
With 50 years of experience manufacturing biologics, the manufacturing processes today are well understood, and the technologies readily accepted by the industry. Unfortunately, the current scale-up approach to manufacturing biologics doesn’t work in a world where therapies are synthesized on a patient by patient basis. Manufacturing these new treatments will require a radical rethink of our approach to both the mechanical and software design. To allow and encourage the industry to break through the current large batch approach we need to ask – what if?
What if we didn’t accept that one set of software is used to develop the therapies in research while a completely different set of software is used for manufacturing in clinical and commercial settings? What if we didn’t accept that the only way to transfer this knowledge from the lab to the plant floor was through complex tech transfers and reinterpretations of the myriad of steps required to go from patient to therapy and back to patient? What if end users didn’t simply accept the status quo that the software is written in languages that haven’t evolved since the 1970’s and hardware is bulky and expensive? What if equipment designers understood that rugged electronics designed for the manufacturing floor aren’t necessarily required in a clean, environmentally controlled, lab environment?
Meeting the challenges posed by the impending avalanche of cell and gene therapies coming to market is going to take a radical rethink of how we deliver automation systems for these manufacturing processes. Part of this new “what if” approach will require borrowing successful technologies from adjacent industries. We must avoid the “not invented here, so it’s not good enough” attitude that has been so pervasive in our industry. Disruptive innovation doesn’t happen when someone builds something new from scratch. Disruptive innovation happens when someone recognizes a need and assembles a variety of disparate technologies in new and creative ways. Innovative companies like Zipline are making life-saving blood deliveries by autonomous drone in Rwanda. They are taking advantage of new technologies developed in the cell phone and other industries and assembling these technologies in new ways to solve old problems.
In an ironic twist it is the biopharmaceutical industry that is pushing ahead with innovations and different approaches at breathtaking speeds. Maybe it’s time the underlying technology for the manufacturing platforms followed suit. Taking the same approach, we have used for the last 30 years surely will yield the same slow, incremental improvements we’ve grown accustomed to. A new and different approach is required. One that leverages the power of the community to innovate and push the boundaries of what’s possible in months instead of waiting for suppliers and years-long development cycles.
Therapies that are on the cusp of commercialization such as CAR-T and even more radical and promising CAR-NK treatments signal the beginning of a revolution in human health. Building a smart platform for manufacturing modern cell and gene therapies isn’t a luxury, it is a necessity. The opportunity is so large, and the impact is so vast that challenging the “inevitables” of the way we deliver solutions today is the only viable path.
By Andy Robinson