Personalized medicine manufacturers are rapidly changing their manufacturing platforms to provide a new scale of production. In the Emerson Exchange Virtual Series, life sciences experts held an open Q&A on the trajectory of cell and gene therapies, and how a different approach to automation helps enable a brave new world of therapeutics.
Cell and gene therapies disrupt manufacturing
Kelsey Hill, Emerson’s life sciences marketing manager, explained that cell and gene therapy is one of the fastest growing segments in life sciences.
Over 40% of new therapies in development leverage cell and gene therapy techniques.
One of the key differences of organizations that develop cell and gene therapy products is that they are focused on identifying specific treatments that are effective based on an individual patient’s genetics. If a provider can understand the genetic fingerprint of a patient, they can better inform clinicians and care providers of what care best fits that patient’s needs. Christian Berg, director of manufacturing at Invitae, explained the game-changing stakes of such focused care.
This allows them to drive better efficacy, better efficiency of care, make treatments more cost effective, and possibly eliminate cancer in our lifetimes.
While traditional life sciences manufacturing is quite different from advanced therapeutics including cell and gene therapy, there are also critical areas where they overlap. Both have strong needs for data integrity and data integration. Jordan Croteau, director of manufacturing and facility systems at Moderna explained that critical areas of focus for automation are
how we can connect all of our systems in the landscape that is already in place, be it ERP systems or an already existing MES… So, it’s really not only the things that are different—which there are a lot of when it comes to the personalized space—but it’s focusing on all the things that are the same and tweaking them just a little bit.
The scale at which personalized medicine facilities operate forces manufacturers to change the way they think about processes and their associated architectures. Among the differences are:
- Smaller, different equipment
- Many batches – one for each patient
- Increased quantity of generated data
- Compressed, individualized batch product release processes
In cell therapy, groups across the facility must collaborate to find the best technologies to meet data, manufacturing, and quality needs.
Unique batches create unique concerns
Other concerns that are critical in personalized medicine are managing chain of identity and chain of custody. When working with personalized genetic material, it becomes even more essential that one batch is not mixed up with another. Moreover, there is significant patient to patient variability. Jordan explained,
If we can find a way to collect the data and really understand how the different variations in incoming materials impact the production process, then we can start to tune our production much more tightly so that we always get the same outcome and each patient batch is successful.
As individualized treatments move from product development and clinical manufacturing to a commercial application scale, the challenges increase during scale-up or scale-out. As manufacturers increase capacity, the plants still need to manage data integrity, traceability, chain of custody, chain of identity, and quality control. Christian clarified the issue,
It’s a data integrity and data volume problem that we’re really staring down. As we’re working through the clinical trials aspect of this next generation of technology, it’s potentially tens of thousands to hundreds of thousands of unique batches in a year… That’s the burning platform for automation and digital transformation as we go into the next generation of healthcare.
One focus of automation in personalized medicine is to improve efficiency. Often, enabling efficiency comes from finding ways to use automation to improve shop floor operations. Michael Cody, senior solution architect at NECI explained,
Any place along that value stream, whether it be your manufacturing shop floor operations or how you’re shipping material from one side of the country to the other, you’re always looking for ways to speed it up.
Cell and gene therapy is small scale and very manual, which creates unique challenges for efficiency. Michael detailed how Emerson’s Syncade offers manufacturing execution system (MES) and electronic batch record (EBR) solutions that are flexible, enabling easier use of modular equipment and adjustable processes containing the procedural knowledge and functions that drive more customized manufacturing.
Part of the solution is achieved by applying flexible technologies that are already in use at life sciences companies and tailoring these technologies to meet the critical needs of cell and gene therapy manufacturers. Emerson’s Michalle Adkins, director of life sciences consulting, explained how the Syncade MES helps to enable critical elements such as chain of identity.
You can scan a particular piece of equipment or a particular batch—usually it’s single use… You can ensure that you’re capturing the right data, the operator is working on the right batch, and you’re producing the right label.
To learn more about how automation is helping advance personalized medicine, you can watch the Q&A in its entirety on demand by registering for the Emerson Exchange Virtual Series. You can also visit the life sciences page at Emerson.com. And don’t forget to comment below to share your stories of adjusting to the changing world of life sciences manufacturing!