In a notable partnership, Switzerland-based Lonza inked a partnership with leading research institutes and academic medical centers including Stanford University School of Medicine, Fred Hutchinson Cancer Research Center and Parker Institute for Cancer Immunotherapy on pioneering autologous cell therapy research and process development projects. Lonza will collaborate with each partner to tech transfer several of their respective cell therapy manufacturing processes into the automated Cocoon® Platform and exhibit the technology’s ability to manufacture in a decentralized model. The partnership, while moving to a more scalable model for cell therapy manufacturing, acknowledges the crucial role research institutes and academic clinical centers fill in developing next-generation cell therapies, such as early-phase clinical cell therapy manufacturing, aims to streamline development timelines, advancing therapies to the clinic faster and make treatment available to more patients.
These premier institutions are leaders in cell-based immunotherapy discovery and development and hence notable news they have elected to collectively partner with Lonza to opt for the use of the Cocoon® Platform for decentralized cell therapy manufacturing capability.
What is Cocoon® Platform?
It is an automated patient-scale cell therapy manufacturing platform. The flexibility to execute a wide variety of protocols within a single system is enabled through a single-use, highly customizable cassette and custom programming.
The Cocoon system is based on an automated GMP-in-a-box concept for patient-scale cell therapy manufacturing. Lonza’s goal here is to offer a scalable, cost-efficient solution to address growing cell therapy manufacturing bottlenecks. Lonza’s Cocoon instrument is a closed, automated, highly flexible cell therapy manufacturing platform according to its website. The Swiss vendor notes that traditionally users compromise flexibility when migrating to a closed, automated system. However, they note this platform bridges this gap via the offering’s single-use, highly customizable cassette. The vendor has infused many years of experience advancing programs from pre-clinical through commercial-scale manufacturing into Cocoon.
Core Features of the System
Lonza reports the following core system features.
· End to end manufacturing of cell therapy products with key unit operations, including isolation, activation, transduction, expansion and harvest
· Fully enclosed manufacturing with minimal touchpoints
· Custom cassettes and custom programming to ensure maximum flexibility with specific process development needs (core element of this announced deal)
· Monitoring and control of temperature and gasses, pH and DO
· Information logging and control with electronic batch records for full product traceability
· Hands-off cultivations through an integrated 4°C cold chamber that allows for preloading of process reagents
· Flexibility for pre-clinical scale, with option to move to restricted unit operation for scale up to commercial manufacturing
· Support services (e.g. the vendor will sell the client consulting around process development, regulatory affairs and quality assurance services
Why are Stanford, Fred Hutch and Parker Institute contracting out their cell manufacturing capability?
Research centers such as Stanford, Fred Hutch and Parker focus is on research—discovery and development of advanced new medicine and therapies. At some point, it becomes more efficient to partner for cell therapy manufacturing capability—to succeed as a Point-of-Care manufacturing for patient-scale cell therapies.
The three prominent institutions sought benefit in collaboration hence the three came together to ink this deal. They will benefit from one central site to observe findings in their initial assessment at Lonza’s Shady Grove (MD) development site. Each organization—Stanford, Fred Hutch and Parker—will evaluate the Lonza Cocoon Platform’s capability against their internal capabilities of cell therapy manufacturing.
They will assess the Swiss vendor’s ability to deliver benefits such as:
· Increased process control
· Reductions in costs & manpower
· Improvements in time & space requirements
· How much more scalable is the vendor’s centralized (yet flexible) approach
Ultimately the goal is to benefit patient populations. The research centers will assess the benefits to determine if they move all activity to this new approach, they will be in a better position to delivery advanced new therapies at scale, hence producing more at a lower cost marginal cost.
Partnership Starts with a Pilot?
According to the press release each collaborating partner will first utilize the Cocoon Platform to assess the system’s automation, flexibility and scalability. Undoubtedly, the research centers have established evaluation criteria centering on the key benefits of automation, flexibility and scalability—some elements are mentioned above.
Call to Action: The scale out and optimization of cell therapy manufacturing represents a critical element in the delivery of advanced immuno-oncology therapies. Hence TrialSite News will monitor as these preeminent institutions evaluate the Cocoon Platform. As updates are made available, we will track and report them.