We have developed molecular and hardware technologies for automated production and purification of these protein-based products. Importantly, the production platform is programmable and can be used to produce virtually any protein-based therapeutic (e.g. vaccines), countermeasure (e.g. toxin neutralizing antibodies and antivenoms) or lab reagent (e.g. cytokines and polymerases). This automated cell-free protein manufacturing platform can rapidly produce and purify cytokines and antibodies at various scales and within a few hours. This is in contrast with current cell-based technologies that could take weeks to express and purify a desired protein, and that require large upfront investments regardless of the production scale. The platform allows just-in-time production and agile scaling, which significantly minimizes capital and inventory costs. This will in turn provide cost savings to researchers who would obtain cytokines and antibodies manufactured through the use of this technology.
Protein-based therapeutics have been an important part of the clinician's toolbox since Pasteur discovered that smallpox infections could be prevented by vaccination. Vaccines are one of the most powerful tools in disease prevention, with childhood diseases, such as polio, smallpox, and diphtheria, largely contained owing to systematic immunizations. Other protein-based therapeutics, such as antibody-directed therapies for cancer, are also an important and growing category of therapeutics that offer increasingly tailored and effective options to fight diseases that have long been recalcitrant to treatment. While exciting, these therapeutics are often costly and can pose a financial burden on even well resourced health care systems. On a global scale, with two thirds of the world living on less than $3/day, most people cannot expect to benefit from many of these advanced medicines. This barrier to the use for protein-based drugs is compounded by the need for most of these drugs to be stored and distributed by an uninterrupted cold chain, which poses a significant challenge for applications in remote regions and in times of urgent need (e.g. infectious disease outbreaks). With the growth of human populations and the increasing frequency of such outbreaks, there is a need for de-centralized solutions to augment the conventional model of drug distribution. Moreover, as personalized medicine becomes further established, there will be a greater need for small-batch production of on-demand custom therapeutics, which at this point largely remains cost prohibitive.
Our purpose-built device aims to address the central challenges of biosafety, portability, cost and need for technical expertise.
- Biosafety: The molecular components in our system are cell-free and thus are biosafe. This means that the device, and the capacity to manufacture proteins, can be brought outside of the lab and made portable.
- Portability: Our purification device is portable and can be battery operated. The device will likely be about the size of a toaster over.
- Cost: Rather than simply plumbing off-the-shelf consumer components together, we are building a device from the ground up. Using this approach, we anticipate our purification device to cost $400 -$700, which is more than an order of magnitude below the estimated cost of competing systems.
- Technical expertise: With the concept of cassette-based production, our automated system will simply require users to add the cassette and press start. All production and purification steps will be automated within the device and therefore do not require user intervention. This is a key differentiator as it is the need for technical skill that currently is a key contributor that limits access to custom proteins.
- Higher Yield: We are also developing a number of key molecular innovations into the system that enable streamlined operation and higher therapeutic yield (therefore lower per dose cost).
- IP in the process of being filed.