Producing pigs for xenotransplantation is not like existing livestock practices. Worldwide, regulators require pathogen-free pigs raised behind a barrier under tightly controlled situations for pigs producing organs for transplant.
These practices are intended to deliver a consistent, quality medical product that has no chance of transmitting disease from pig to man.
Separating the production from design, as is done elsewhere, facilitates the rapid development in the field.
In xenotransplantation, the terms used are “pathogen free pigs” reared in a “designated pathogen free” (DPF) environment.
Each company designing pigs for xenotransplantation is devising a DPF for their own genetic designs without regard to the likelihood that advances in genetic designs will obsolete their products rapidly.
We expect rapid product advancement and turnover in the early period of xenotransplantation. New developments will come, as they have in the past, from academics and institutions with access to the samples from early cases will have the greatest advantage.
New genetic designs that have advantages, such as improved survival, larger compatible populations, or decreased immunosuppression and complications will quickly make older designs obsolete. A company with the leading design could be challenged and defeated very quickly.
We expect the xenotransplantation industry to be like computer chip industry where new designs, and companies, can be implemented in silicon faster and cheaper by independent chip fabricator experts. This separation allowed companies like AMD and now Nvidea to grow and thrive by using TSMC as a fabricator. Even Intel is separating chip design and chip fabrication in response to competition.
Typical construction methods are not well suited to xenotransplantation. The fixed designs now used require apriori knowledge of pregnancy rate, litter size, growth rate, and yield to size. For a specific product these design criteria can only be estimated and will vary greatly with different varieties and genetic designs. efficiency ’s explosive growth potential.
It takes 2 to 4 years to generate the first organ from a traditional sticks and bricks designed DPF including construction and the time it takes to populate the facility and grow animals to the size needed. For fast growing pig varieties, DPF designs for a 1,000 organ per year cost $30 to $50M with a yearly operating cost of at least $6M. For the minipigs and growth retarded pigs used by many genomic designers, the cost might be 50% to 100% more to provide for the longer growth period to size.